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DIAGNOSIS AND TREATMENT OF LUMBAR DISC

HERNIATION WITH RADICULOPATHY


TECHNICAL REPORT (2012)

I. Literature Search Parameters....2


II. Evidentiary Tables.15
I. Literature Search Parameters (1947 July 2011)

Databases Searched:
MEDLINE (PubMed)
ACP Journal Club
Cochrane Database of Systematic Reviews
Database of Abstracts of Reviews of Effectiveness (DARE)
Cochrane Central Register of Controlled Trials
EMBASE Drugs and Pharmacology
Web of Science

Natural History of Lumbar Disc Herniation with Radiculopathy


Search Strategies by Clinical Question

1. What is the best working definition of lumbar disc herniation with radiculopathy?
2. What is the natural history of lumbar disc herniation with radiculopathy?

(("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang]))
AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR
("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[All Fields]) AND ("humans"[MeSH Terms] AND English[lang])) AND "natural history"[All Fields]

Diagnosis/Imaging of Lumbar Disc Herniation with Radiculopathy


Search Strategies by Clinical Question

1. What history and physical examination findings best support a diagnosis of lumbar disc herniation with radiculopathy?

((("lumbar"[title] AND diagnosis[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms]
AND English[lang])) AND ("Physical Examination"[Mesh] OR "Medical History Taking"[Mesh] OR history[title] OR examination[title] OR
findings[title] AND ("humans"[MeSH Terms] AND English[lang])) AND ("humans"[MeSH Terms] AND English[lang])) AND
(("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR
("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND ("humans"[MeSH Terms] AND English[lang])

2. What are the most appropriate diagnostic tests (including imaging and electrodiagnostics), and when are these tests indicated in the
evaluation and treatment of symptomatic lumbar disc herniation with radiculopathy?

((("lumbar"[title] AND diagnosis[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms]
AND English[lang])) AND ("Diagnostic Techniques and Procedures"[Mesh] OR "Diagnosis"[Mesh] AND ("humans"[MeSH Terms] AND
English[lang])) AND ("humans"[MeSH Terms] AND English[lang])) AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR
("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR ("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields])
OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND
("humans"[MeSH Terms] AND English[lang])

Medical/Interventional Treatment of Lumbar Disc Herniation with Radiculopathy


Search Strategies by Clinical Question

1. What is the role of pharmacological treatment in the management of lumbar disc herniation?

(("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR


("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND (("lumbar"[title] AND ("pharm*"[title] OR drug[title]) AND
("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang]))

2. What is the role of physical therapy/exercise in the treatment of lumbar disc herniation?

(("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR


("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND (((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title]
OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang])) AND ("Physical Therapy Modalities"[Mesh] OR "physical
therapy"[title])) OR ((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms]
AND English[lang])) AND ("Exercise"[Mesh] OR "Physical Fitness"[Mesh] OR "exercise"[title] OR "physical fitness"[title])))
3. What is the role of spinal manipulation in the treatment of lumbar disc herniation?

(("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR


("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND ((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title]
OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang])) AND ((("Musculoskeletal Manipulations"[Mesh] OR
"Manipulation, Chiropractic"[Mesh]) OR "Manipulation, Spinal"[Mesh]) OR "Chiropractic"[Mesh] OR "manipulation"[title] OR
"chiropractic"[title]))

4. What is the role of traction (manual or mechanical) in the treatment of lumbar disc herniation?

(("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR


("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND ((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title]
OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang])) AND ("traction"[mesh] OR "traction"[title]))

5. a.What is the role of epidural steroid injections for the treatment of lumbar disc herniation?
b. Is there an optimal frequency or quantity of injections for the treatment of lumbar disc herniations?
c. Does the approach (interlaminar, transforaminal, caudal) influence the risks or effectiveness of epidural steroid injections in the
treatment of lumbar disc herniations?

(("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR


("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND ((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title]
OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang])) AND (("Injections, Spinal"[Mesh] OR (("Injections"[Mesh] OR
injections[title]) AND (transforaminal[All Fields] OR interlaminar[All Fields] OR caudal[All Fields]))) OR "Nerve Block"[Mesh]))

6. What is the role of interventional spine procedures such as intradiscal electrothermal annuloplasty (IDEA or IDET) and percutaneous
discectomy (chemical or mechanical) in the treatment of lumbar disc herniation?

(("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR


("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND ((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title]
OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang])) AND ("Electric Stimulation Therapy"[Mesh] OR idet[All Fields]
OR "idea"[All Fields] OR (intradiscal[All Fields] AND electrothermal[All Fields] AND ("therapy"[Subheading] OR "therapy"[All Fields] OR
"therapeutics"[MeSH Terms] OR "therapeutics"[All Fields])) OR (intradiscal[All Fields] AND electrothermal[All Fields] AND
annuloplasty[All Fields]) OR ("diskectomy, percutaneous"[MeSH Terms] OR ("diskectomy"[All Fields] AND "percutaneous"[All Fields]) OR
"percutaneous diskectomy"[All Fields] OR ("percutaneous"[All Fields] AND "discectomy"[All Fields]) OR "percutaneous discectomy"[All
Fields]) OR (("intervertebral"[All Fields] AND "disk"[All Fields] AND "chemolysis"[All Fields]) OR "chemonucleolysis"[All Fields])))

7. What is the role of ancillary treatments such as bracing, electrical stimulation, acupuncture, and transcutaneous electrical stimulation
(TENS) in the treatment of lumbar disc herniation?

((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang]))
AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR
("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang]))) AND ((("Braces"[Mesh] OR "Traction"[Mesh]) OR ("Electric
Stimulation"[Mesh] OR "Electric Stimulation Therapy"[Mesh])) OR ("Acupuncture Therapy"[Mesh] OR "Acupuncture"[Mesh]) OR
bracing[title] OR brace[title] OR braces[title] OR traction[title] OR "electrical stimulation"[title] OR "electrostimulation"[title] OR
acupuncture[title] OR TENS[title])

8a. What is the likelihood that a patient with lumbar disc herniation with radiculopathy undergoing medical/interventional treatment would
have good/excellent functional outcomes at short (weeks to 6 months), medium (6 months - 2 years) and long-term (greater than 2
years)?

((((((((("lumbar"[title] AND diagnosis[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH


Terms] AND English[lang])) AND ("Physical Examination"[Mesh] OR "Medical History Taking"[Mesh] OR history[title] OR
examination[title] OR findings[title] AND ("humans"[MeSH Terms] AND English[lang])) AND ("humans"[MeSH Terms] AND English[lang]))
AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR
("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND ("humans"[MeSH Terms] AND English[lang])) OR
(((("lumbar"[title] AND diagnosis[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH
Terms] AND English[lang])) AND ("Diagnostic Techniques and Procedures"[Mesh] OR "Diagnosis"[Mesh] AND ("humans"[MeSH Terms]
AND English[lang])) AND ("humans"[MeSH Terms] AND English[lang])) AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR
("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR ("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields])
OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND
("humans"[MeSH Terms] AND English[lang]))) OR ((("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH
Terms] OR "radiculopathy"[All Fields]) OR ("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All
Fields] OR "polyradiculitis"[All Fields] OR radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND (("lumbar"[title] AND
("pharm*"[title] OR drug[title]) AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND
English[lang])))) OR ((("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All
Fields]) OR ("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All
Fields] OR radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND ((("lumbar"[title] AND ("herniation"[title] OR
"protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang])) AND (("Injections, Spinal"[Mesh] OR
(("Injections"[Mesh] OR injections[title]) AND (transforaminal[All Fields] OR interlaminar[All Fields] OR caudal[All Fields]))) OR "Nerve
Block"[Mesh])))) OR ((("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All
Fields]) OR ("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All
Fields] OR radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND ((("lumbar"[title] AND ("herniation"[title] OR
"protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang])) AND ("Electric Stimulation Therapy"[Mesh]
OR idet[All Fields] OR "idea"[All Fields] OR (intradiscal[All Fields] AND electrothermal[All Fields] AND ("therapy"[Subheading] OR
"therapy"[All Fields] OR "therapeutics"[MeSH Terms] OR "therapeutics"[All Fields])) OR (intradiscal[All Fields] AND electrothermal[All
Fields] AND annuloplasty[All Fields]) OR ("diskectomy, percutaneous"[MeSH Terms] OR ("diskectomy"[All Fields] AND "percutaneous"[All
Fields]) OR "percutaneous diskectomy"[All Fields] OR ("percutaneous"[All Fields] AND "discectomy"[All Fields]) OR "percutaneous
discectomy"[All Fields]) OR (("intervertebral"[All Fields] AND "disk"[All Fields] AND "chemolysis"[All Fields]) OR "chemonucleolysis"[All
Fields]))))) OR (((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND
English[lang])) AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All
Fields]) OR ("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All
Fields] OR radicular[title]) AND ("humans"[MeSH Terms] AND English[lang]))) AND ((("Braces"[Mesh] OR "Traction"[Mesh]) OR ("Electric
Stimulation"[Mesh] OR "Electric Stimulation Therapy"[Mesh])) OR ("Acupuncture Therapy"[Mesh] OR "Acupuncture"[Mesh]) OR
bracing[title] OR brace[title] OR braces[title] OR traction[title] OR "electrical stimulation"[title] OR "electrostimulation"[title] OR
acupuncture[title] OR TENS[title]))) AND ("Treatment Outcome"[Mesh] OR short-term[All Fields] OR medium-term[All Fields] OR long-
term[All Fields] OR "time"[mesh] OR "longitudinal studies"[MeSH])
8b. Are there prognostic factors (eg, age, duration or severity of symptoms) that make it more likely that a patient with lumbar disc
herniation with radiculopathy will have good/excellent functional outcomes at short (weeks to 6 months), medium (6 months - 2 years)
and long-term (greater than 2 years) following medical/interventional treatment?

((((((((("lumbar"[title] AND diagnosis[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH


Terms] AND English[lang])) AND ("Physical Examination"[Mesh] OR "Medical History Taking"[Mesh] OR history[title] OR
examination[title] OR findings[title] AND ("humans"[MeSH Terms] AND English[lang])) AND ("humans"[MeSH Terms] AND English[lang]))
AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR
("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND ("humans"[MeSH Terms] AND English[lang])) OR
(((("lumbar"[title] AND diagnosis[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH
Terms] AND English[lang])) AND ("Diagnostic Techniques and Procedures"[Mesh] OR "Diagnosis"[Mesh] AND ("humans"[MeSH Terms]
AND English[lang])) AND ("humans"[MeSH Terms] AND English[lang])) AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR
("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR ("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields])
OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND
("humans"[MeSH Terms] AND English[lang]))) OR ((("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH
Terms] OR "radiculopathy"[All Fields]) OR ("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All
Fields] OR "polyradiculitis"[All Fields] OR radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND (("lumbar"[title] AND
("pharm*"[title] OR drug[title]) AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND
English[lang])))) OR ((("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All
Fields]) OR ("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All
Fields] OR radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND ((("lumbar"[title] AND ("herniation"[title] OR
"protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang])) AND (("Injections, Spinal"[Mesh] OR
(("Injections"[Mesh] OR injections[title]) AND (transforaminal[All Fields] OR interlaminar[All Fields] OR caudal[All Fields]))) OR "Nerve
Block"[Mesh])))) OR ((("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All
Fields]) OR ("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All
Fields] OR radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND ((("lumbar"[title] AND ("herniation"[title] OR
"protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang])) AND ("Electric Stimulation Therapy"[Mesh]
OR idet[All Fields] OR "idea"[All Fields] OR (intradiscal[All Fields] AND electrothermal[All Fields] AND ("therapy"[Subheading] OR
"therapy"[All Fields] OR "therapeutics"[MeSH Terms] OR "therapeutics"[All Fields])) OR (intradiscal[All Fields] AND electrothermal[All
Fields] AND annuloplasty[All Fields]) OR ("diskectomy, percutaneous"[MeSH Terms] OR ("diskectomy"[All Fields] AND "percutaneous"[All
Fields]) OR "percutaneous diskectomy"[All Fields] OR ("percutaneous"[All Fields] AND "discectomy"[All Fields]) OR "percutaneous
discectomy"[All Fields]) OR (("intervertebral"[All Fields] AND "disk"[All Fields] AND "chemolysis"[All Fields]) OR "chemonucleolysis"[All
Fields]))))) OR (((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND
English[lang])) AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All
Fields]) OR ("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All
Fields] OR radicular[title]) AND ("humans"[MeSH Terms] AND English[lang]))) AND ((("Braces"[Mesh] OR "Traction"[Mesh]) OR ("Electric
Stimulation"[Mesh] OR "Electric Stimulation Therapy"[Mesh])) OR ("Acupuncture Therapy"[Mesh] OR "Acupuncture"[Mesh]) OR
bracing[title] OR brace[title] OR braces[title] OR traction[title] OR "electrical stimulation"[title] OR "electrostimulation"[title] OR
acupuncture[title] OR TENS[title]))) AND ("incidence"[MeSH Terms:noexp] OR "mortality"[MeSH Terms] OR "follow-up studies"[MeSH
Terms:noexp] OR (prognos[Text Word] OR prognoscan[Text Word] OR prognose[Text Word] OR prognosed[Text Word] OR
prognoses[Text Word] OR prognosi[Text Word] OR prognosic[Text Word] OR prognosies[Text Word] OR prognosing[Text Word] OR
prognosis[Text Word] OR prognosis/clinical[Text Word] OR prognosis/course[Text Word] OR prognosis/diagnosis[Text Word] OR
prognosis/drug[Text Word] OR prognosis/favorable[Text Word] OR prognosis/fear[Text Word] OR prognosis/good[Text Word] OR
prognosis/invasion[Text Word] OR prognosis/metastasis[Text Word] OR prognosis/outcome[Text Word] OR prognosis/outcomes[Text
Word] OR prognosis/prevention[Text Word] OR prognosis/prognostic[Text Word] OR prognosis/survival[Text Word] OR
prognosis/therapy[Text Word] OR prognosis/wish[Text Word] OR prognosis'[Text Word] OR prognosis''[Text Word] OR prognosisa[Text
Word] OR prognosisand[Text Word] OR prognosised[Text Word] OR prognosises[Text Word] OR prognosisof[Text Word] OR
prognosiss[Text Word] OR prognosistic[Text Word] OR prognositc[Text Word] OR prognositcally[Text Word] OR prognosite[Text Word]
OR prognositic[Text Word] OR prognositification[Text Word] OR prognosits[Text Word] OR prognosls[Text Word] OR prognosonis[Text
Word] OR prognososis[Text Word] OR prognosprognosis[Text Word] OR prognossis[Text Word] OR prognostc[Text Word] OR
prognosti[Text Word] OR prognostiating[Text Word] OR prognostic[Text Word] OR prognostic/clinicopathological[Text Word] OR
prognostic/diagnostic[Text Word] OR prognostic/end[Text Word] OR prognostic/experimental[Text Word] OR
prognostic/metastatic[Text Word] OR prognostic/pharmacogenetic[Text Word] OR prognostic/predicting[Text Word] OR
prognostic/predictive[Text Word] OR prognostic/predictors[Text Word] OR prognostic/progression[Text Word] OR
prognostic/proliferative[Text Word] OR prognostic/risk[Text Word] OR prognostic/severity[Text Word] OR prognostic/staging[Text Word]
OR prognostic/survival[Text Word] OR prognostic/therapeutic[Text Word] OR prognostic/treatment[Text Word] OR prognostic'[Text
Word] OR prognostic's[Text Word] OR prognostica[Text Word] OR prognosticable[Text Word] OR prognosticably[Text Word] OR
prognosticaion[Text Word] OR prognostical[Text Word] OR prognostically[Text Word] OR prognosticaly[Text Word] OR
prognosticantly[Text Word] OR prognosticants[Text Word] OR prognosticate[Text Word] OR prognosticated[Text Word] OR
prognosticates[Text Word] OR prognosticating[Text Word] OR prognostication[Text Word] OR prognostications[Text Word] OR
prognosticative[Text Word] OR prognosticator[Text Word] OR prognosticator's[Text Word] OR prognosticators[Text Word] OR
prognosticatory[Text Word] OR prognosticfactors[Text Word] OR prognosticfeature[Text Word] OR prognostician[Text Word] OR
prognosticians[Text Word] OR prognosticity[Text Word] OR prognosticks[Text Word] OR prognosticly[Text Word] OR
prognosticmeasurement[Text Word] OR prognostico[Text Word] OR prognosticon[Text Word] OR prognosticrisk[Text Word] OR
prognostics[Text Word] OR prognostification[Text Word] OR prognostify[Text Word] OR prognostigate[Text Word] OR
prognostigram[Text Word] OR prognostikon[Text Word] OR prognostis[Text Word] OR prognostische[Text Word] OR prognostisity[Text
Word] OR prognostive[Text Word] OR prognostix[Text Word] OR prognostocrit[Text Word] OR prognostric[Text Word] OR
prognosys[Text Word]) OR (predict[Text Word] OR predict/1[Text Word] OR predict/affect[Text Word] OR predict/assess[Text Word] OR
predict/classify[Text Word] OR predict/control[Text Word] OR predict/determine[Text Word] OR predict/estimate[Text Word] OR
predict/evaluate[Text Word] OR predict/exclude[Text Word] OR predict/explain[Text Word] OR predict/interpret[Text Word] OR
predict/monitor[Text Word] OR predict/prognosticate[Text Word] OR predict/rank[Text Word] OR predict/rationalize[Text Word] OR
predict/recover[Text Word] OR predict/refine[Text Word] OR predict/relate[Text Word] OR predict/rule[Text Word] OR
predict/sunnybrook[Text Word] OR predict'[Text Word] OR predict''[Text Word] OR predict's[Text Word] OR predict7[Text Word] OR
predicta[Text Word] OR predictab[Text Word] OR predictabe[Text Word] OR predictabel[Text Word] OR predictabilities[Text Word] OR
predictability[Text Word] OR predictability/rhythm[Text Word] OR predictability/unpredictability[Text Word] OR predictability'[Text
Word] OR predictability''[Text Word] OR predictabilty[Text Word] OR predictable[Text Word] OR predictable/controlled[Text Word] OR
predictable/unclear[Text Word] OR predictable/unpredictable[Text Word] OR predictable/variable[Text Word] OR predictable'[Text
Word] OR predictables[Text Word] OR predictablity[Text Word] OR predictably[Text Word] OR predictabuity[Text Word] OR
predictal[Text Word] OR predictalbe[Text Word] OR predictand[Text Word] OR predictands[Text Word] OR predictaquatic[Text Word] OR
predictar[Text Word] OR predictated[Text Word] OR predictative[Text Word] OR predictbias[Text Word] OR predictcancer[Text Word]
OR predictd[Text Word] OR predicte[Text Word] OR predicted[Text Word] OR predicted/100[Text Word] OR predicted/30[Text Word] OR
predicted/actual[Text Word] OR predicted/assumed[Text Word] OR predicted/baseline[Text Word] OR predicted/dlco[Text Word] OR
predicted/established[Text Word] OR predicted/expected[Text Word] OR predicted/explained[Text Word] OR predicted/fvc[Text Word]
OR predicted/have[Text Word] OR predicted/hypothesized[Text Word] OR predicted/hypothetical[Text Word] OR
predicted/measured[Text Word] OR predicted/observed[Text Word] OR predicted/predicted[Text Word] OR
predicted/recommended[Text Word] OR predicted/sd[Text Word] OR predicted/se[Text Word] OR predicted/uncharacterized[Text
Word] OR predicted/unit[Text Word] OR predicted/validated[Text Word] OR predicted/y[Text Word] OR predicted/year[Text Word] OR
predicted/yr[Text Word] OR predicted'[Text Word] OR predictedfrom[Text Word] OR predictedl[Text Word] OR predictedl/e[Text Word]
OR predictedmore[Text Word] OR predictedness[Text Word] OR predictee[Text Word] OR predictees[Text Word] OR predicter[Text
Word] OR predicters[Text Word] OR predictet[Text Word] OR predictfurors[Text Word] OR predictibility[Text Word] OR predictible[Text
Word] OR predictically[Text Word] OR predictice[Text Word] OR predictie[Text Word] OR predictied[Text Word] OR predictif[Text Word]
OR predictifs[Text Word] OR predictim[Text Word] OR predictin[Text Word] OR predictinf[Text Word] OR predicting[Text Word] OR
predicting/assembling[Text Word] OR predicting/assessing[Text Word] OR predicting/estimating[Text Word] OR
predicting/evaluating[Text Word] OR predicting/optimizing[Text Word] OR predicting/preventing[Text Word] OR predicting'[Text Word]
OR predictinginteractions[Text Word] OR predictingprognosis[Text Word] OR predictingthe[Text Word] OR predictintegral[Text Word]
OR predictio[Text Word] OR predictiom[Text Word] OR prediction[Text Word] OR prediction/3[Text Word] OR prediction/analysis[Text
Word] OR prediction/annotation[Text Word] OR prediction/assessment[Text Word] OR prediction/case[Text Word] OR
prediction/characterization[Text Word] OR prediction/confirmation[Text Word] OR prediction/control[Text Word] OR
prediction/detection[Text Word] OR prediction/diagnosis[Text Word] OR prediction/estimation[Text Word] OR
prediction/expectation[Text Word] OR prediction/experimental[Text Word] OR prediction/explanation[Text Word] OR
prediction/extrapolation[Text Word] OR prediction/feedback[Text Word] OR prediction/frisc[Text Word] OR prediction/histology[Text
Word] OR prediction/identification[Text Word] OR prediction/integration[Text Word] OR prediction/national[Text Word] OR
prediction/optimization[Text Word] OR prediction/parameter[Text Word] OR prediction/postdiction[Text Word] OR
prediction/ppfinder[Text Word] OR prediction/precipitation/prevention[Text Word] OR prediction/prevention[Text Word] OR
prediction/prognosis[Text Word] OR prediction/recognition[Text Word] OR prediction/reproducibility[Text Word] OR
prediction/sensitivity[Text Word] OR prediction/sensitivity/specificity[Text Word] OR prediction/singular[Text Word] OR
prediction/treatment[Text Word] OR prediction/verification[Text Word] OR prediction'[Text Word] OR prediction's[Text Word] OR
prediction36[Text Word] OR predictionable[Text Word] OR predictional[Text Word] OR predictionalgorithms[Text Word] OR
predictioncenter[Text Word] OR predictioncenter/casp6/org[Text Word] OR predictioning[Text Word] OR predictions[Text Word] OR
predictions/estimates[Text Word] OR predictions/garp[Text Word] OR predictions/h[Text Word] OR predictions/impressions[Text Word]
OR predictions/number[Text Word] OR predictions/total[Text Word] OR predictions'[Text Word] OR predictionst[Text Word] OR
predictit[Text Word] OR predictition[Text Word] OR predictitive[Text Word] OR predictiv[Text Word] OR predictivas[Text Word] OR
predictive[Text Word] OR predictive/confounding[Text Word] OR predictive/criterion[Text Word] OR predictive/data[Text Word] OR
predictive/descriptive[Text Word] OR predictive/diagnostic[Text Word] OR predictive/early[Text Word] OR
predictive/face/construct[Text Word] OR predictive/proactive[Text Word] OR predictive/prognostic[Text Word] OR
predictive/protective[Text Word] OR predictive/risk[Text Word] OR predictive/screening[Text Word] OR predictive/surrogate[Text Word]
OR predictive/validation[Text Word] OR predictive/vector[Text Word] OR predictive'[Text Word] OR predictivefactors[Text Word] OR
predictively[Text Word] OR predictively'[Text Word] OR predictiveness[Text Word] OR predictiveness'[Text Word] OR predictiveof[Text
Word] OR predictives[Text Word] OR predictivetrade[Text Word] OR predictivevalue[Text Word] OR predictivites[Text Word] OR
predictivities[Text Word] OR predictivity[Text Word] OR predictivo[Text Word] OR predictivre[Text Word] OR predictivy[Text Word] OR
predictly[Text Word] OR predictment[Text Word] OR predictnls[Text Word] OR predictol[Text Word] OR predictome[Text Word] OR
predictomics[Text Word] OR predicton[Text Word] OR predictons[Text Word] OR predictor[Text Word] OR predictor/correlate[Text
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predictor/independent[Text Word] OR predictor/mediator[Text Word] OR predictor/moderator[Text Word] OR predictor/outcome[Text
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predictors/determinants[Text Word] OR predictors/formulas[Text Word] OR predictors/indicators[Text Word] OR
predictors/institutionalization[Text Word] OR predictors/markers[Text Word] OR predictors/measures[Text Word] OR
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coursersef[Text Word] OR courses[Text Word] OR courses/1[Text Word] OR courses/1,000[Text Word] OR courses/100[Text Word] OR
courses/165[Text Word] OR courses/24[Text Word] OR courses/33[Text Word] OR courses/activities[Text Word] OR
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courses/classes[Text Word] OR courses/clerkships[Text Word] OR courses/conferences[Text Word] OR courses/congresses[Text Word]
OR courses/course[Text Word] OR courses/cycle[Text Word] OR courses/disciplines[Text Word] OR courses/individual[Text Word] OR
courses/lectures[Text Word] OR courses/materials[Text Word] OR courses/nt/is[Text Word] OR courses/patient[Text Word] OR
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courses/schools[Text Word] OR courses/seminars[Text Word] OR courses/themes/topics[Text Word] OR courses/topics[Text Word] OR
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Word] OR coursewise[Text Word] OR coursework[Text Word] OR coursework/continuing[Text Word] OR coursey[Text Word]))

Surgical Treatment of Lumbar Disc Herniation with Radiculopathy

1a. Are there signs or symptoms associated with lumbar radiculopathy that predict a favorable surgical outcome?

(((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang]))
AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR
("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang]))) AND ("Surgical Procedures, Operative"[Mesh] OR microdiscectomy[All
Fields] OR ("laminectomy"[MeSH Terms] OR "laminectomy"[All Fields]) OR ("laminectomy"[MeSH Terms] OR "laminectomy"[All Fields]
OR "laminotomy"[All Fields]) OR (("endoscopy"[MeSH Terms] OR "endoscopy"[All Fields] OR "endoscopic"[All Fields]) AND
("diskectomy"[MeSH Terms] OR "diskectomy"[All Fields] OR "discectomy"[All Fields])) OR ("Nucl Eng Des/Fusion"[Journal] OR "fusion"[All
Fields]))) AND (symptom[All Fields] OR ("diagnosis"[Subheading] OR "diagnosis"[All Fields] OR "symptoms"[All Fields] OR
"diagnosis"[MeSH Terms] OR "symptoms"[All Fields]) OR ("signs and symptoms"[MeSH Terms] OR ("signs"[All Fields] AND
"symptoms"[All Fields]) OR "signs and symptoms"[All Fields] OR "finding"[All Fields]) OR ("diagnosis"[Subheading] OR "diagnosis"[All
Fields] OR "findings"[All Fields] OR "diagnosis"[MeSH Terms] OR "findings"[All Fields]) OR indicate[All Fields] OR indication[All Fields] OR
indications[All Fields])

1b. What is the role of epidural steroid injections or selective nerve root blocks in diagnosis or patient selection for subsequent surgical
treatment of a lumbar disc herniation?

(("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR


("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang])) AND ((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title]
OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang])) AND (("Injections, Spinal"[Mesh] OR (("Injections"[Mesh] OR
injections[title]) AND (transforaminal[All Fields] OR interlaminar[All Fields] OR caudal[All Fields]))) OR "Nerve Block"[Mesh])) AND
(("diagnosis"[Subheading] OR "diagnosis"[All Fields] OR "diagnosis"[MeSH Terms]) OR ("patient selection"[MeSH Terms] OR ("patient"[All
Fields] AND "selection"[All Fields]) OR "patient selection"[All Fields]))

2. When is the optimal timing for surgical intervention?

(((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang]))
AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR
("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang]))) AND ("Surgical Procedures, Operative"[Mesh] OR microdiscectomy[All
Fields] OR ("laminectomy"[MeSH Terms] OR "laminectomy"[All Fields]) OR ("laminectomy"[MeSH Terms] OR "laminectomy"[All Fields]
OR "laminotomy"[All Fields]) OR (("endoscopy"[MeSH Terms] OR "endoscopy"[All Fields] OR "endoscopic"[All Fields]) AND
("diskectomy"[MeSH Terms] OR "diskectomy"[All Fields] OR "discectomy"[All Fields])) OR ("Nucl Eng Des/Fusion"[Journal] OR "fusion"[All
Fields]))) AND (("time"[MeSH Terms] OR "time"[All Fields]) OR timing[All Fields])

3. Does discectomy (with or without preoperative medical/interventional treatment) result in better outcomes (clinical or radiographic)
than medical/interventional treatment for lumbar disc herniation?

((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang]))
AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR
("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang]))) AND ("Diskectomy"[Mesh] OR ("diskectomy"[MeSH Terms] OR
"diskectomy"[All Fields] OR "discectomy"[All Fields]) OR ("diskectomy"[MeSH Terms] OR "diskectomy"[All Fields]))

4. Are there clinical circumstances in which lumbar fusion is appropriate in the treatment of lumbar disc herniation?

((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang]))
AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR
("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang]))) AND ("Spinal Fusion"[Mesh] OR fusion[title])
5. Is there a difference in outcome (clinical or radiographic) or complications between different surgical approaches in the treatment of a
lumbar disc herniation?

(((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang]))
AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR
("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang]))) AND ("Surgical Procedures, Operative"[Mesh] OR microdiscectomy[All
Fields] OR ("laminectomy"[MeSH Terms] OR "laminectomy"[All Fields]) OR ("laminectomy"[MeSH Terms] OR "laminectomy"[All Fields]
OR "laminotomy"[All Fields]) OR (("endoscopy"[MeSH Terms] OR "endoscopy"[All Fields] OR "endoscopic"[All Fields]) AND
("diskectomy"[MeSH Terms] OR "diskectomy"[All Fields] OR "discectomy"[All Fields])) OR ("Nucl Eng Des/Fusion"[Journal] OR "fusion"[All
Fields]))) AND ("treatment outcome"[MeSH] OR ("complications"[Subheading] OR "complications"[All Fields]))

6. What are the medium-term (1 - 4 years) and long-term (greater than four years) results of surgical management of lumbar disc
herniation?

(((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang]))
AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR
("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang]))) AND ("surgery"[subheading] OR "Surgical Procedures,
Operative"[Mesh] OR microdiscectomy[All Fields] OR ("laminectomy"[MeSH Terms] OR "laminectomy"[All Fields]) OR
("laminectomy"[MeSH Terms] OR "laminectomy"[All Fields] OR "laminotomy"[All Fields]) OR (("endoscopy"[MeSH Terms] OR
"endoscopy"[All Fields] OR "endoscopic"[All Fields]) AND ("diskectomy"[MeSH Terms] OR "diskectomy"[All Fields] OR "discectomy"[All
Fields])) OR ("Nucl Eng Des/Fusion"[Journal] OR "fusion"[All Fields])) OR "surg*"[title]) AND (medium-term[All Fields] OR "medium
term"[All Fields] OR "long term"[All Fields] OR long-term[All Fields])

7. Is there a difference in outcome or complications between different sites of service for the surgical management of a lumbar disc
herniation?

((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang]))
AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR
("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang]))) AND "Health Facilities"[Mesh]
Value of Spine Care

1. What is the cost-effectiveness of treatment options in the management of lumbar disc herniation?

((("lumbar"[title] AND ("herniation"[title] OR "protrusion"[title] OR "extrusion"[title])) AND ("humans"[MeSH Terms] AND English[lang]))
AND (("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR ("radiculopathy"[MeSH Terms] OR "radiculopathy"[All Fields]) OR
("polyradiculopathy"[MeSH Terms] OR "polyradiculopathy"[All Fields]) OR "radiculitis"[All Fields] OR "polyradiculitis"[All Fields] OR
radicular[title]) AND ("humans"[MeSH Terms] AND English[lang]))) AND ("economics"[subheading] OR "Costs and Cost Analysis"[Mesh]
OR cost-effective[All Fields] OR ("cost-benefit analysis"[MeSH Terms] OR ("cost-benefit"[All Fields] AND "analysis"[All Fields]) OR "cost-
benefit analysis"[All Fields] OR ("cost"[All Fields] AND "effectiveness"[All Fields]) OR "cost effectiveness"[All Fields]))

2. Does the surgical approach for lumbar disc herniation have an affect on the value of treatment?

3. Does the site-of-service chosen for surgical management of lumbar disc herniation affect the value of treatment?
II. Evidentiary Tables (Articles Reviewed in 2011/2012)

Lumbar Disc Herniation


Natural History

Of the studies reviewed to address the natural history of lumbar disc herniation with radiculopathy or radiculitis, none provided
adequate subgroup analyses relative to the natural history of patients that were untreated.
Question #3:
What history and physical examination findings best support a diagnosis of lumbar disc herniation?

Article Level
(Alpha by of Description of study Conclusion
Author) evidenc
e

Albeck MJ. A Level III Prospective Retrospective Critique of methodology


critical Nonconsecutive patients
assessment Type of Study Design: case series Small sample size
of clinical evidenc No universally-applied gold standard
diagnosis of e Stated objective of study: To verify the reliability of clinical No consistently applied gold standard
disc diagnosticparameters in the diagnosis of lumbar disc herniation. Poor reference standard/no gold
herniation in standard applied
patients with Diagnostic test(s) studied: Lacked subgroup analysis
monoradicular Clinical exam/history Other:
sciatica. Acta Electromyography
Neurochirurgi Myelogram
ca. MRI Work group conclusions
1996;138(1):4 CT Potential Level: III
0-44. CT/Myelogram Downgraded Level:
Other:
Conclusions relative to question
Compared to: This paper provides evidence
Clinical exam/history that:Monoradicular sciatica is predictive of
Electromyography a disc herniation affecting the 5th lumbar or
Myelogram first sacral root.
MRI
CT
CT/Myelogram
Other: intraoperative assessment

Gold standard used? Yes No


If so, what was the gold standard? surgery

Number of patients: 80
Consecutively assigned? No

Results/subgroup analysis (relevant to question): Using


clinical parameters, when a disc was present the level of the
disc herniation was predicted accurately in 93%. However,
only sciatica was predictive of disc herniation; onset, worker's
compensation, scoliosis, segmental spasm, trunk list,
"provided" pain, finger-floor distance, straight leg raise,
paresis, muscle wasting, impaired reflex and hypesthesia
were not reliably predictive of a disc herniation.

Author conclusions (relative to question): In patients with


monoradicular sciatica further clinical parameters do not add
to the diagnosis of lumbar disc herniation.

Christodoulid Level III Prospective Retrospective Critique of methodology


es AN. Nonconsecutive patients
Ipsilateral Type of Study Design: case series Small sample size
sciatica on evidenc No universally-applied gold standard
femoral nerve e Stated objective of study: To determine the diagnostic value No consistently applied gold standard
stretch test is diagnosticof a femoral nerve stretch test combined with a straight leg Poor reference standard/no gold
pathognomoni raise. standard applied
c of an L4/5 Lacked subgroup analysis
disc Diagnostic test(s) studied: Other:
protrusion. J Clinical exam/history
Bone Joint Electromyography
Surg Br. Jan Myelogram Work group conclusions
1989;71(1):88 MRI Potential Level: III
-89. CT Downgraded Level:
CT/Myelogram
Other: Conclusions relative to question
This paper provides evidence that:In
Compared to: patients with suspected L4/5 disc
Clinical exam/history protrusion, the induction of sciatica during
Electromyography the femoral nerve stretch test may be
Myelogram diagnostic of a lesion at this level.
MRI
CT
CT/Myelogram
Other: Intraoperative assessment

Gold standard used? Yes No


If so, what was the gold standard? surgery

Number of patients: 40/200

Consecutively assigned? No

Results/subgroup analysis (relevant to question): All forty


patients with positive femoral nerve stretch testing had a disc
herniation confirmed by surgical exploration. Two patients
with negative myelographic studies were found to have
lateral disc herniations at surgery.

Author conclusions (relative to question): In patients with


suspected L4/5 disc protrusion, the induction of sciatica
during the femoral nerve stretch test is diagnostic of a lesion
at this level.

Jensen OH. Level I Prospective Retrospective Critique of methodology


The level- Nonconsecutive patients
diagnosis of a Type of Study Design: case series Small sample size
lower lumbar evidenc No universally-applied gold standard
disc e Stated objective of study: The purpose of this study was to No consistently applied gold standard
herniation: the diagnosticcalculate the positive predictive value and negative predictive Poor reference standard/no gold
value of value of sensory and motor abnormalities as signs of the standard applied
sensibility and level of a lower lumbar disc herniation. Lacked subgroup analysis
motor testing. Other:
Clin Diagnostic test(s) studied:
Rheumatol. Clinical exam/history
Dec Electromyography Work group conclusions
1987;6(4):564 Myelogram Potential Level: I
-569. MRI Downgraded Level:
CT
CT/Myelogram Conclusions relative to question
Other: sensory and motor compared to contralateral side This paper provides evidence that:Sensory
and motor testing of a patient with a
Compared to: suspected lumbar disc herniation and
Clinical exam/history sciatica can provide specific clues to the
Electromyography level of disc herniation, but are not very
Myelogram sensitive in determining the exact level.
MRI
CT
CT/Myelogram
Other:

Gold standard used? Yes No


If so, what was the gold standard? surgery

Number of patients: 52

Consecutively assigned? Yes

Results/subgroup analysis (relevant to question): Sensory


abnormalities were found in 54% of patients with a herniated
disc. The positive predictive value (PPV) of sensory
disturbances in the L5 dermatome as a sign of a L4-5 disc
herniation was 76% and the negative predictive value (NPV)
was 55%. The PPV of sensory disturbance in the S1
dermatome as a sign of a L5-S1 disc herniation was 50%
and the NPV was 62%. Motor weakness was found in 54%
of patients. The PPV of paresis of dorsiflexion of the foot as
a sign on herniated disc at L4-5 was 69% and the NPV was
47%. The PPV of paresis of the four lateral toes as a sign of
L4-5 herniated disc was calculated to be 76% and the NPV to
be 51%.

Author conclusions (relative to question): Pin prick


sensibility, especially in the foot, and muscular strength of
dorsiflexion of the foot and extension of the lateral four toes
should be tested in patients with a suspected lumbar nerve
compression syndrome. If a lower herniated nucleus
pulposus is suspected, hypalgesia in the L5 dermatome and
paresis of the above mentioned muscle synergies offer rather
specific clues as to the level of the herniation, but these signs
are unfortunately not very sensitive.

Jonsson B, Level II Prospective Retrospective Critique of methodology


Stromqvist B. Nonconsecutive patients
Symptoms Type of Study Design: comparative Small sample size
and signs in evidenc No universally-applied gold standard
degeneration e Stated objective of study: to determine the frequency of some No consistently applied gold standard
of the lumbar diagnosticof the common symptoms in patients with lumbar nerve-root Poor reference standard/no gold
spine. A compression and to evaluate the frequency of neurological standard applied
prospective, disturbances in different groups of patients. Lacked subgroup analysis
consecutive Other: Heterogenous group of
study of 300 Diagnostic test(s) studied: herniated discs at multiple levels. No
operated Clinical exam/history analysis of which level corresponded with
patients. J Electromyography which symptoms.
Bone Joint Myelogram
Surg Br. May MRI
1993;75(3):38 CT Work group conclusions
1-385. CT/Myelogram Potential Level: II
Other: Downgraded Level:

Compared to: Conclusions relative to question


Clinical exam/history This paper provides evidence that:Nerve
Electromyography root tension signs are often positive in
Myelogram patients with a disc herniation.
MRI
CT
CT/Myelogram
Other: One or more of the above

Gold standard used? Yes No


If so, what was the gold standard? surgery
Number of patients: 100/300

Consecutively assigned? Yes

Results/subgroup analysis (relevant to question): Reduced


spinal mobility was very common, being found in 96% of
patients with disc herniation. The median duration of
preoperative leg pain was two years in stenosis as compared
with five months in cases of disc herniation. Of the patients
with complete disc herniation, 63% had a straight leg raise of
less than 30 degrees. In patients with disc hernia there was a
motor deficit of the involved root in 69% and a sensory
disturbance in 60%.

Author conclusions (relative to question): The preoperative


duration of symptoms was signficantly shorter in patients with
disc herniation. Pain at rest, at night, and on coughing was
as common in lateral stenosis as in disc herniation, but
regular consumption of analgesics was more common in
patients with disc herniation. Positive straight-leg-raising
tests were very common in disc herniation. Sensory
disturbances were most common in patients with complete
disc herniations.

Kortelainen P, Level I Prospective Retrospective Critique of methodology


Puranen J, Nonconsecutive patients
Koivisto E, Type of Study Design: case series Small sample size
Lahde S. evidenc No universally-applied gold standard
Symptoms e Stated objective of study: to evaluate the reliability of the No consistently applied gold standard
and signs of diagnosticclinical diagnosis of level of ruptured disc and the utility of Poor reference standard/no gold
sciatica and lumbar myelography for gaining further information. standard applied
their relation Lacked subgroup analysis
to the Diagnostic test(s) studied: Other:
localization of Clinical exam/history
the lumbar Electromyography
disc Myelogram Work group conclusions
herniation. MRI Potential Level: I
Spine (Phila CT Downgraded Level:
Pa 1976). CT/Myelogram
Jan-Feb Other: Conclusions relative to question
1985;10(1):88 This paper provides evidence that:physical
-92. Compared to: examination, including subjective and
Clinical exam/history objective findings such as positive straight
Electromyography leg raise, sensory testing and myotomal
Myelogram weakness, in a patient with a suspected
MRI lumbar disc herniation and sciatica can
CT provide specific clues to the level of disc
CT/Myelogram herniation.
Other:

Gold standard used? Yes No


If so, what was the gold standard? surgery

Number of patients: 403

Consecutively assigned? Yes

Results/subgroup analysis (relevant to question): For L5,


pain projection was 79% reliable; the reliability rose to 86%
with extensor hallucis longus (EHL) weakness. S1 pain was
56% reliable; dropped Achilles raised reliability to 80%; and
the addition of a sensory deficit raised the probability to 86%.
Myelography was accurate in 90.8% with a 3.7% false
positive rate and a 5.5% false negative rate.

Author conclusions (relative to question):


The cough impulse test was positive in 74% of patients with a
disc herniation. Lasegue's sign was positive in 94% of
patients with a disc herniation. However, these findings are
non-specific. A positive straight leg raise occurred less
frequently with high level lumbar disc herniations and was
more commonly positive under 30 degrees for lower
herniations. Projected pain could be localized according to
the distribution of the lumbosacral roots in 93% of cases.
Pain projection was the most important symptom localizing
the level, particularly in the area of the fifth lumbar root. Part
of the sensory disturbance, as well as the pain projection,
from the L4-5 disc is distributed to the first sacral area. The
achilles reflex was of value in the diagnosis of L5-S1 disc
ruptures when associated with pain projection and sensory
deficit in the first sacral root. The patellar reflex had no value
in the diagnosis of low lumbar lesions. EHL weakness was
due to L4-5 rupture in 70% of cases and was a strong sign of
L4-5 rupture even if first sacral root projection was present.

Majlesi J, Level III Prospective Retrospective Critique of methodology


Togay H, Nonconsecutive patients
Unalan H, Type of Study Design: case control Small sample size
Toprak S. The evidenc No universally-applied gold standard
sensitivity and e Stated objective of study: to measure the sensitivity and No consistently applied gold standard
specificity of diagnosticspecificity of the Slump test and compare it with the straight Poor reference standard/no gold
the Slump leg raise test in patients with and without lumbar disc standard applied
and the herniations. Lacked subgroup analysis
Straight Leg Other:
Raising tests Diagnostic test(s) studied:
in patients Clinical exam/history
with lumbar Electromyography Work group conclusions
disc Myelogram Potential Level: III
herniation. J MRI Downgraded Level:
Clin CT
Rheumatol. CT/Myelogram Conclusions relative to question
Apr Other: Slump test and straight leg raise This paper provides evidence that:the
2008;14(2):87 Slump test and straight leg raise had
-91. Compared to: similar specificity in the diagnosis of a
Clinical exam/history herniated lumbar disc, but the Slump test
Electromyography was more sensitive.
Myelogram
MRI
CT
CT/Myelogram
Other:
Gold standard used? Yes No
If so, what was the gold standard? MRI

Number of patients: 38; 37 controls

Consecutively assigned? No

Results/subgroup analysis (relevant to question): When all


the patients were considered, the sensitivity of the Slump test
was 0.84, and its specificity was 0.83. The sensitivity of the
straight leg raise test was 0.52, and its specificity was 0.89.
These make the positive predictive values of the Slump and
the straight leg raise 0.84 (confidence interval: 0.740.90),
and 0.83 (confidence interval: 0.0.67 0.92), respectively.
And the negative predictive values were 0.83 (confidence
interval: 0.73 0.90) and 0.64 (confidence interval: 0.57
0.69), respectively.

Author conclusions (relative to question): The results of this


study show that, although overlooked over the years, due to
its sensitivity, the Slump test may be a valuable tool for
suggesting a diagnosis of lumbar disc herniation, and could
be used extensively.

Poiraudeau S, Level I Prospective Retrospective Critique of methodology


Foltz V, Nonconsecutive patients
Drape JL, et Type of Study Design: case series Small sample size
al. Value of evidenc No universally-applied gold standard
the bell test e Stated objective of study: to evaluate the reliability, No consistently applied gold standard
and the diagnosticsensitivity, specificity, positive predictive value and negative Poor reference standard/no gold
hyperextensio predictive value for the diagnosis of sciatica associated with standard applied
n test for disc herniation of the bell test and hyperextension test. Lacked subgroup analysis
diagnosis in Other: mix of acute/chronic
sciatica Diagnostic test(s) studied:
associated Clinical exam/history
with disc Electromyography Work group conclusions
herniation: Myelogram Potential Level: I
comparison MRI Downgraded Level:
with CT
Lasegue's CT/Myelogram Conclusions relative to question
sign and the Other: Bell test (pressure at interspinous level), This paper provides evidence that:all four
crossed hyperextension test, Lasegue's, crossed leg diagnostic tests (hyperextension, Bell,
Lasegue's Lasegue's and Crossed Lasegue's) are
sign. Compared to: useful in diagnosing lumbar disc herniation
Rheumatolog Clinical exam/history with radiculopathy.
y (Oxford). Electromyography
Apr Myelogram
2001;40(4):46 MRI
0-466. CT
CT/Myelogram
Other: sacroradiculography

Gold standard used? Yes No


If so, what was the gold standard? MR, CT, or myelogram

Number of patients: 43/78

Consecutively assigned? Yes

Results/subgroup analysis (relevant to question): Lasegue's


sign had the best sensitivity 0.77-0.83, while the crossed leg
test had the best specificity (0.74-0.89). Overall, the positive
predictive value for all four signs were fair (0.55-0.69) and the
negative predictive values were weak to fair (0.45-0.63).

Author conclusions (relative to question): The clinical values


of the Bell test and hyperextension test are of interest and at
least similar to those of Lasegue's and Crossed Lasegue's
signs. The combination of hyperextension with Crossed
Lasegue's has excellent specificity and a good positive
predictive value for the diagnosis of sciatica associated with
disc herniation. Thus the Bell test and hyperextension test
could be performed systematically in standardized physical
examination of sciatica.

Rabin A, Level I Prospective Retrospective Critique of methodology


Gerszten PC, Nonconsecutive patients
Karausky P, Type of Study Design: case series Small sample size
Bunker CH, evidenc No universally-applied gold standard
Potter DM, e Stated objective of study: To compare the sensitivity of two No consistently applied gold standard
Welch WC. diagnosticmethods of performing the straight-leg raise (SLR) test, one Poor reference standard/no gold
The sensitivity in the supine position and the other in the seated position, in standard applied
of the seated patients presenting with signs and symptoms consistent with Lacked subgroup analysis
straight-leg lumbar radiculopathy. Other: mixed duration (at least four
raise test weeks)
compared Diagnostic test(s) studied:
with the Clinical exam/history
supine Electromyography Work group conclusions
straight-leg Myelogram Potential Level: I
raise test in MRI Downgraded Level:
patients CT
presenting CT/Myelogram Conclusions relative to question
with magnetic Other: seated vs. supine straight leg raise This paper provides evidence that:the
resonance supine SLR is moderately sensitive in
imaging Compared to: diagnosing lumbar disc herniation with
evidence of Clinical exam/history radiculopathy. The supine SLR is more
lumbar nerve Electromyography sensitive than the seated SLR in
root Myelogram diagnosing lumbar disc herniation with
compression. MRI radiculopathy.
Arch Phys CT
Med Rehabil. CT/Myelogram
Jul Other:
2007;88(7):84
0-843. Gold standard used? Yes No
If so, what was the gold standard? MRI

Number of patients: 57

Consecutively assigned? Yes


Results/subgroup analysis (relevant to question): The
sensitivity (95% CI) of the supine SLR test in reproducing the
patients radicular pain in light of an MRI scan indicating the
presence of nerve root compression was .67 (95% CI, 0.53-
0.79). The sensitivity (95% CI) of the seated SLR
test was at .41 (95% CI, 0.29-0.55). This represented a
statistically significant difference with a p value of 0.003.

Author conclusions (relative to question): The traditional SLR


test performed in a supine position is more sensitive in
reproducing leg pain than the seated SLR test in patients
presenting with signs and symptoms consistent with lumbar
radiculopathy with MRI evidence of nerve root compression.

Summers B, Level I Prospective Retrospective Critique of methodology


Mishra V, Nonconsecutive patients
Jones JM. Type of Study Design: case series Small sample size
The flip test: a evidenc No universally-applied gold standard
reappraisal. e Stated objective of study: to test the construct validity of the No consistently applied gold standard
Spine (Phila diagnosticflip test against the passive supine straight leg raise (SLR) in Poor reference standard/no gold
Pa 1976). Jul patients with classic clinical signs of sciatica standard applied
1 Lacked subgroup analysis
2009;34(15):1 Diagnostic test(s) studied: Other:
585-1589. Clinical exam/history
Electromyography
Myelogram Work group conclusions
MRI Potential Level: I
CT Downgraded Level:
CT/Myelogram
Other: flip test Conclusions relative to question
This paper provides evidence that:Sitting
Compared to: and supine straight leg raising tests have
Clinical exam/history discrepancy. Flip Test (Sitting SLR) is
Electromyography positive when supine straight leg raising
Myelogram test is positive at less than 45 degrees.
MRI
CT
CT/Myelogram
Other: Supine SLR

Gold standard used? Yes No


If so, what was the gold standard? MRI

Number of patients: 67

Consecutively assigned? Yes

Results/subgroup analysis (relevant to question): The kappa


was calculated taking different cut-off points, and maximum
agreement occurred at 48/49 SLR. Kappa 0.771; 95%
confidence interval: 0.611 to 0.932.

Author conclusions (relative to question): Flip Test remains a


useful check of nerve root tension but only for patients with
supine SLRs below 45. The most reliable response was not
a flip but the demonstration of pain on extension of the knee.
We would recommend the term sitting SLR test, as a more
accurate and less misleading name.

Vucetic N, Level I Prospective Retrospective Critique of methodology


Svensson O. Nonconsecutive patients
Physical signs Type of Study Design: case series Small sample size
in lumbar disc evidenc No universally-applied gold standard
hernia. e Stated objective of study: to investigate if the physical signs No consistently applied gold standard
Clinical diagnosticcould predict the degree of lumbar disc herniation Poor reference standard/no gold
Orthopaedics standard applied
and Related Diagnostic test(s) studied: Lacked subgroup analysis
Research. Clinical exam/history Other:
1996(333):19 Electromyography
2-201. Myelogram
MRI Work group conclusions
CT Potential Level: I
CT/Myelogram Downgraded Level:
Other: lumbar ROM, Lasegue signs, pin prick testing,
reflexes and motor testing for foot Conclusions relative to question
This paper provides evidence
Compared to: that:Crossed Lasegue testing and lumbar
Clinical exam/history range of motion in the sagittal plane may
Electromyography be helpful in predicting the type of disc
Myelogram herniation.
MRI
CT
CT/Myelogram
Other: surgery

Gold standard used? Yes No


If so, what was the gold standard? surgery

Number of patients: 163

Consecutively assigned? Yes

Results/subgroup analysis (relevant to question): Lumbar


range of motion and crossed Lasegue testing was helpful in
predicting 71% of ruptured annulus and 80% of intact
annulus

Author conclusions (relative to question): Lumbar ROM and


Crossed Lasegue sign were the only significant physical
examination findings which predict the degree of herniation.
Question #4:
What are the most appropriate diagnostic tests (including imaging and electrodiagnostics), and when are
these tests indicated in the evaluation and treatment of symptomatic lumbar disc herniation?

Article Level
(Alpha by of Description of study Conclusion
Author) evidence

Albeck MJ, Level II Prospective Retrospective Critique of methodology


Taher G, Nonconsecutive patients
Lauritzen M, Type of Study Design: case series Small sample size
Trojaborg W. evidence No universally-applied gold standard
Diagnostic diagnostic Stated objective of study: To assess the diagnostic No consistently applied gold standard
value of value of electrophysiological tests in patients with Poor reference standard/no gold standard
electrophysiol sciatica. applied
ogical tests in Lacked subgroup analysis
patients with Diagnostic test(s) studied: Other:
sciatica. Acta Clinical exam/history
Neurol Electromyography
Scand. Apr Myelogram Work group conclusions
2000;101(4):2 MRI Potential Level: I
49-254. CT Downgraded Level: II
CT/Myelogram
Other: electrophysiologic (EMG, nerve Conclusions relative to question
conduction velocities, dermatomal sensory evoked This paper provides evidence that:
potentials, F-wave, H-reflex) electrodiagnostic testing (electromyography,
nerve conduction studies, F-waves,
Compared to: somatosensory evoked potentials) has limited
Clinical exam/history diagnostic value in patients with lumbar disc
Electromyography herniation with radiculopathy, though H-reflex
Myelogram has a high positive predictive value for S1
MRI radiculopathy.
CT
CT/Myelogram
Other: surgery
Gold standard used? Yes No
If so, what was the gold standard? surgery

Number of patients: 20/25

Consecutively assigned? Yes

Results/subgroup analysis (relevant to question): A


high predictive value was found for the H reflex
examination, but low for the other modalities.

Author conclusions (relative to question): The


diagnostic value of electrophysiological tests in
patients with sciatica is limited.

Beyaz EA, Level III Prospective Retrospective Critique of methodology


Akyz G, Us Nonconsecutive patients
O. The role of Type of Study Design: case control Small sample size
somatosensor evidence No universally-applied gold standard
y evoked diagnostic Stated objective of study: To determine whether No consistently applied gold standard
potentials in sensory evoked potentials (SEPs) make a Poor reference standard/no gold standard
the diagnosis contribution far beyond that of conventional applied
of methods, to compare lumbar recordings to cortical Lacked subgroup analysis
lumbosacral ones, and to compare follow sensory nerve Other:
radiculopathie stimulated SEPs to following mixed nerve stimulated
s. ones in the diagnosis of lumbar disc herniation
Electromyogr Work group conclusions
aphy and Diagnostic test(s) studied: Potential Level: III
clinical Clinical exam/history Downgraded Level:
neurophysiolo Electromyography
gy. Myelogram Conclusions relative to question
2009(4):131- MRI This paper provides evidence that: SEPs may
142. CT provide diagnostic information beyond
http://www.mr CT/Myelogram conventional electrodiagnostic studies.
w.interscienc Other: SEP (scalp vs lumbar and sensory vs Electromyography, nerve conduction studies
e.wiley.com/c mixed nerve) and F-waves are of limited utility. H-reflexes
ochrane/clcen have a relatively high sensitivity and specificity
tral/articles/42 Compared to: in the diagnosis of S1 radiculopathy.
3/CN- Clinical exam/history
00698423/fra Electromyography
me.html. Myelogram
MRI
CT
CT/Myelogram
Other: Late response (F wave, H reflex), Nerve
conduction

Gold standard used? Yes No


If so, what was the gold standard? MRI

Number of patients: 20 and 18 controls

Consecutively assigned? No

Results/subgroup analysis (relevant to


question): Sensitivities were: EMG 50%, lumbar-
recorded sural SEP 39%, scalp recorded sural SEP
33%, H reflex 28%, lumbar recorded post tibial 22%,
scalp post tibial 17%, F wave 6%. Specificities were:
EMG 100%, late response and scalp-recorded
posterior tibial SEP 100%, lumbar-recorded sural
SEP 50%

Author conclusions (relative to question): SEPs may


provide diagnostic information beyond conventional
electrodiagnostic methods and that lumbar-recorded
SEPs may have an advantage over scalp-recorded
ones and sensory nerve stimulated SEPs over mixed
nerve stimulated ones

Dillingham Level III Prospective Retrospective Critique of methodology


TR, Dasher Nonconsecutive patients
KJ. The Type of Study Design: case series Small sample size
lumbosacral evidence No universally-applied gold standard
electromyogr diagnostic Stated objective of study: to use this previously No consistently applied gold standard
aphic screen: collected data and determine the minimum number Poor reference standard/no gold standard
revisiting a of muscles needed to identify subjects with EMG and applied
classic paper. surgically confirmed lumbar disc herniations. Lacked subgroup analysis
Clin Other:
Neurophysiol. Diagnostic test(s) studied:
Dec Clinical exam/history
2000;111(12): Electromyography Work group conclusions
2219-2222. Myelogram Potential Level: III
MRI Downgraded Level:
CT
CT/Myelogram Conclusions relative to question
Other: This paper provides evidence that:a four
muscle electromyography screen is sensitive
Compared to: in the diagnosis of nerve root compression,
Clinical exam/history though this is not specific for the level of
Electromyography involvement.
Myelogram
MRI
CT
CT/Myelogram
Other: surgery

Gold standard used? Yes No


If so, what was the gold standard? surgery

Number of patients: 206

Consecutively assigned? No

Results/subgroup analysis (relevant to


question): Selected four muscle EMG screens
identified over 97% of EMG confirmed
radiculopathies and over 89% of surgically confirmed
disc herniations.
Author conclusions (relative to question): These
findings underscore the utility of four muscle EMG
screens in the evaluation of patients with suspected
lumbosacral radiculopathy.

Dumitru D, Level III Prospective Retrospective Critique of methodology


Dreyfuss P. Nonconsecutive patients
Dermatomal/s Type of Study Design: case control Small sample size
egmental evidence No universally-applied gold standard
somatosensor diagnostic Stated objective of study: to evaluate the diagnostic No consistently applied gold standard
y evoked utility of both dermatomal and segmental Poor reference standard/no gold standard
potential somatosensory evoked potentials (SEPs) with applied
evaluation of respect to unilateral/unilevel L5 or S1 nerve root Lacked subgroup analysis
L5/S1 compromise. Other:
unilateral/unil
evel Diagnostic test(s) studied:
radiculopathie Clinical exam/history Work group conclusions
s. Muscle Electromyography Potential Level: III
Nerve. Apr Myelogram Downgraded Level:
1996;19(4):44 MRI
2-449. CT Conclusions relative to question
CT/Myelogram This paper provides evidence that:SEPs are
Other: SEP specific for the diagnosis of lumbar
radiculopathy when compared to
Compared to: asymptomatic controls, though are less reliable
Clinical exam/history in determining the exact level of involvement
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: control

Gold standard used? Yes No


If so, what was the gold standard? CT/MRI

Number of patients: 20
Consecutively assigned? No

Results/subgroup analysis (relevant to


question): the specificity for both segmental and
dermatomal evaluations were found to be equal to or
greater than 93%, with most values approaching
98%. Unfortunately, the sensitivities for these same
techniques were considerably less. The superficial
peroneal nerve segmental study proposed for
assessing L5 radicular insults demonstrated the best
sensitivity with values at 70% and 60%, respective
confidence intervals of 90% and 95%. Dermatomal
responses for the fifth lumbar root evaluating these
same L5 radiculopathies revealed sensitivities of
50% for both with 90% and 95% confidence interval
levels. The SEP evaluations of S1 radicular insults
for sural nerve and S1 dermatomal responses
demonstrated respective sensitivities of 30% and
20% for both studies at 90% confidence intervals,
while the respective 95% confidence interval values
were 30% and 10%

Author conclusions (relative to question): The


clinical utility of both segmental and dermatomal
SEPs are questionable in patients with known
unilateral/unilevel L5 and S1 nerve root compromise.

Fries JW, Level I Prospective Retrospective Critique of methodology


Abodeely DA, Nonconsecutive patients
Vijungco JG, Type of Study Design: comparative Small sample size
Yeager VL, evidence No universally-applied gold standard
Gaffey WR. diagnostic Stated objective of study: to compare CT to No consistently applied gold standard
Computed myelography in the diagnosis of herniated nucleus Poor reference standard/no gold standard
tomography pulposus applied
of herniated Lacked subgroup analysis
and extruded Diagnostic test(s) studied: Other:
nucleus Clinical exam/history
pulposus. J Electromyography
Comput Myelogram Work group conclusions
Assist MRI Potential Level: I
Tomogr. Oct CT Downgraded Level:
1982;6(5):874 CT/Myelogram
-887. Other: Conclusions relative to question
This paper provides evidence that: CT and
Compared to: myelography show comparable rates of
Clinical exam/history diagnosis of lumbar disc herniation.
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: surgery

Gold standard used? Yes No


If so, what was the gold standard? surgery

Number of patients: 185

Consecutively assigned? Yes

Results/subgroup analysis (relevant to


question): Using CT imaging the true positive rate
was 92% to diagnose a disc herniation whereas it
was 87% using myelography. The false negative
rate was 8% using CT and 13% using myelography.
The true negative rate using CT was 78% and 89%
with myelography. The false positive rate with CT
was 22% and 11% with myelography.

Author conclusions (relative to question):

Jackson RP, Level I Prospective Retrospective Critique of methodology


Cain JE, Jr., Nonconsecutive patients
Jacobs RR, Type of Study Design: comparative Small sample size
Cooper BR, evidence No universally-applied gold standard
McManus diagnostic Stated objective of study: to compare the relative No consistently applied gold standard
GE. The accuracies of CT, myelography, CT myelography Poor reference standard/no gold standard
neuroradiogra and MRI in the diagnosis of a herniated nucleus applied
phic pulposus Lacked subgroup analysis
diagnosis of Other:
lumbar Diagnostic test(s) studied:
herniated Clinical exam/history
nucleus Electromyography Work group conclusions
pulposus: II. Myelogram Potential Level: I
A comparison MRI Downgraded Level:
of computed CT
tomography CT/Myelogram Conclusions relative to question
(CT), Other: This paper provides evidence that:MRI, CT
myelography, myelography, myelography and CT show
CT- Compared to: equivalent rates in diagnosing lumbar disc
myelography, Clinical exam/history herniation in symptomatic patients.
and magnetic Electromyography
resonance Myelogram
imaging. MRI
Spine (Phila CT
Pa 1976). CT/Myelogram
Dec Other: surgery
1989;14(12):1
362-1367. Gold standard used? Yes No
If so, what was the gold standard? surgery

Number of patients: 59; 52 with HNP and 7 controls

Consecutively assigned? Yes

Results/subgroup analysis (relevant to


question): MRI was the most accurate test 76.5%,
myelo CT was 76%, CT was 73.6%, and
myelography was 71.4%. Myelo CT had the lowest
false negative rate 27.2% whereas MRI had the
lowest false positive rate 13.5%. Although the
difference was not statistically significant, myelo CT
had the greatest sensitivity (72.8%) and MRI had the
greatest specificity (86.5%)

Author conclusions (relative to question): MRI


compares very favorably with other currently
available imaging modalities for diagnosing lumbar
disc herniation.

Janssen ME, Level I Prospective Retrospective Critique of methodology


Bertrand SL, Nonconsecutive patients
Joe C, Levine Type of Study Design: case series Small sample size
MI. Lumbar evidence No universally-applied gold standard
herniated disk diagnostic Stated objective of study: To compare the accuracy, No consistently applied gold standard
disease: sensitivity, specificity, cost and safety of MRI, Poor reference standard/no gold standard
comparison of myelography and post-myelographic CT scan in the applied
MRI, diagnosis of lumbar disc herniation. Lacked subgroup analysis
myelography, Other:
and post- Diagnostic test(s) studied:
myelographic Clinical exam/history
CT scan with Electromyography Work group conclusions
surgical Myelogram Potential Level: I
findings. MRI Downgraded Level:
Orthopedics. CT
Feb CT/Myelogram Conclusions relative to question
1994;17(2):12 Other: This paper provides evidence that:MRI
1-127. provided the most sensitivity and specificity in
Compared to: the diagnosis of lumbar disc herniation when
Clinical exam/history compared to myelography or CT-myelography.
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: surgery
Gold standard used? Yes No
If so, what was the gold standard? surgery

Number of patients: 60

Consecutively assigned? Yes

Results/subgroup analysis (relevant to


question): MRI accurately predicted operative
findings in 98/102 disc levels (96%), while the
accuracy of myelography (81%) and post-myelogram
CT scan (57%) was significantly less. When
myelography and CT scan were combined, the
accuracy was 84%.

Author conclusions (relative to question): The


results of this study reflect that MRI is a clinically
superior diagnostic test in the evaluation of patients
with suspected lumbar disc herniation, and that it
should be the diagnostic study of choice when
available.

Marin R, Level IV Prospective Retrospective Critique of methodology


Dillingham Nonconsecutive patients
TR, Chang A, Type of Study Design: case control Small sample size
Belandres evidence No universally-applied gold standard
PV. Extensor diagnostic Stated objective of study: to assess the sensitivity No consistently applied gold standard
digitorum and specificity of the clinical and electrodiagnostic Poor reference standard/no gold standard
brevis reflex extensor digitorium brevis reflex (EDBR) in a normal applied
in normals population and in patients with L-5 and S-1 Lacked subgroup analysis
and patients radiculopathies, in an effort to find a useful L-5 deep Other:
with tendon reflex.
radiculopathie
s. Muscle Diagnostic test(s) studied: Work group conclusions
Nerve. Jan Clinical exam/history Potential Level: III
1995;18(1):52 Electromyography Downgraded Level: IV
-59. Myelogram
MRI Conclusions relative to question
CT This paper provides evidence that:the extensor
CT/Myelogram digitorum brevis reflex electrophysiological
Other: clinical and electrodiagnostic EDBR studies and clinical exam do not distinguish
between L5 or S1 radiculopathy and are not
Compared to: ideal screening tools.
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Gold standard used? Yes No


If so, what was the gold standard? MRI, not
consistently

Number of patients: 35/88

Consecutively assigned? No

Results/subgroup analysis (relevant to


question): The sensitivity of electrodiagnostic
extensor digitorum brevis reflex was 35% for the L5
root and 39% for the S1 root and 37% for combined
radiculopathy. The specificity was 87%. The H reflex
sensitivity for L5 was 6% and S1 was 50% with a
specificity of 91%.

Author conclusions (relative to question): EDBR


(extensor digitorum brevis reflex) clinical and
electrodiagnostic reflexes have low sensitivities, high
specificities, and do not discriminate L-5 from S-1
root involvement

Pape E, Level I Prospective Retrospective Critique of methodology


Eldevik OP, Nonconsecutive patients
Vandvik B. Type of Study Design: case series Small sample size
Diagnostic evidence No universally-applied gold standard
validity of diagnostic Stated objective of study: to study the validity of No consistently applied gold standard
somatosensor sensory nerve SEP to diagnose L4, L5, and S1 Poor reference standard/no gold standard
y evoked sensory radiculopathy in sciatica and to examine applied
potentials in whether SEP-diagnosed nerve root compromise is Lacked subgroup analysis
subgroups of associated with the type of radiologically diagnosed Other:
patients with degeneration of the lumbar spine, the presence of
sciatica. sensory sciatic symptoms during registration, the
European spinal level, the number of nerve root lesions, Work group conclusions
Spine previous sciatic episodes, and the duration of the Potential Level: I
Journal. Feb present episode. Downgraded Level:
2002;11(1):38
-46. Diagnostic test(s) studied: Conclusions relative to question
Clinical exam/history This paper provides evidence that:SEP has
Electromyography strong validity in patients with nerve root
Myelogram compression but has low specificity in the
MRI diagnosis of lumbar disc herniation.
CT
CT/Myelogram
Other: SEP

Compared to:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Gold standard used? Yes No


If so, what was the gold standard? Myelogram,
CT/Myelogram

Number of patients: 65
Consecutively assigned? Yes

Results/subgroup analysis (relevant to


question): The true-positive rate was higher in
patients with facet joint hypertrophy with or without
additional disc disease than in patients with disc
pathology only, and highest if the sciatic sensory
symptoms were present during the SEP
registration.

Author conclusions (relative to question): SEP can


be used as an additional diagnostic procedure to
imaging studies if the latter do not fully clarify
whether or not there is nerve root compromise.

Pfirrmann Level I Prospective Retrospective Critique of methodology


CW, Dora C, Nonconsecutive patients
Schmid MR, Type of Study Design: case series Small sample size
Zanetti M, evidence No universally-applied gold standard
Hodler J, diagnostic Stated objective of study: to describe a system for No consistently applied gold standard
Boos N. MR grading lumbar nerve root compromise depicted on Poor reference standard/no gold standard
image-based routine MR images, to evaluate its reliability and to applied
grading of correlate image-based grades with surgical grades. Lacked subgroup analysis
lumbar nerve Other:
root Diagnostic test(s) studied:
compromise Clinical exam/history
due to disk Electromyography Work group conclusions
herniation: Myelogram Potential Level: I
reliability MRI Downgraded Level:
study with CT
surgical CT/Myelogram Conclusions relative to question
correlation. Other: This paper provides evidence that:there is a
Radiology. high correlation between MRI interpretation
Feb Compared to: and operative findings of disc herniations.
2004;230(2):5 Clinical exam/history
83-588. Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: surgery

Gold standard used? Yes No


If so, what was the gold standard? surgery

Number of patients: 68/80

Consecutively assigned? Yes

Results/subgroup analysis (relevant to


question): The Spearman correlation coefficient was
high between MRI grading and surgical findings (r =
0.86, P < .001).

Author conclusions (relative to question): The MR


imagebased grading system used in this study
enables discrimination between grades of nerve root
compromise in the lumbar spine with sufficient
reliability for both research and clinical purposes.

Samuelsson Level I Prospective Retrospective Critique of methodology


L, Lundin A. Nonconsecutive patients
Thermal Type of Study Design: case control Small sample size
quantitative evidence No universally-applied gold standard
sensory diagnostic Stated objective of study: To evaluate whether No consistently applied gold standard
testing in thermal quantitative sensory testing (QST) is Poor reference standard/no gold standard
lumbar disc applicable in the study of sensory dysfunction in applied
herniation. lumbosacral disc herniations. Lacked subgroup analysis
European Other:
Spine
Journal. Diagnostic test(s) studied:
2002;11(1):71 Clinical exam/history Work group conclusions
-75. Electromyography Potential Level: I
Myelogram Downgraded Level:
MRI
CT Conclusions relative to question
CT/Myelogram This paper provides evidence that:thermal
Other: thermal quantitative sensory testing quantitative sensory testing has differing
thresholds between symptomatic and normal
Compared to: dermatomes, but is not accurate in localizing
Clinical exam/history the level.
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: surgery

Gold standard used? Yes No


If so, what was the gold standard? surgery

Number of patients: 69

Consecutively assigned? Yes

Results/subgroup analysis (relevant to


question): The discriminant analysis showed that
the proportion of herniated discs classified correctly
was 48% in patients with disc herniations at the L4/5
level and 71% at the L5/S1 level.

Author conclusions (relative to question): There was


a significant difference in thermal thresholds
between all dermatomes representing different nerve
root levels as well as between the side of the
herniated disc and the corresponding asymptomatic
side. However, thermal QST seems to have the
same poor predictive value for identifying the
anatomic location of a herniated lumbar disc as
conventional electrophysiologic methods.

Tabaraud F, Level III Prospective Retrospective Critique of methodology


Hugon J, Nonconsecutive patients
Chazot F, et Type of Study Design: case control Small sample size
al. Motor evidence No universally-applied gold standard
evoked diagnostic Stated objective of study: To determine how No consistently applied gold standard
responses accurate motor evoked potentials are in the Poor reference standard/no gold standard
after lumbar diagnosis of radiculopathy in patients with applied
spinal complaints of radiculopathy with or without objective Lacked subgroup analysis
stimulation in neurological signs. Other:
patients with
L5 or S1 Diagnostic test(s) studied:
radicular Clinical exam/history Work group conclusions
involvement. Electromyography Potential Level: III
Electroencep Myelogram Downgraded Level:
halogr Clin MRI
Neurophysiol. CT Conclusions relative to question
Apr CT/Myelogram This paper provides evidence that: motor
1989;72(4):33 Other: motor evoked potentials (MEP) evoked potentials may be helpful in diagnosing
4-339. radiculopathy.
Compared to:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Gold standard used? Yes No


If so, what was the gold standard? surgery

Number of patients: 45 LDH; 25 controls

Consecutively assigned? No
Results/subgroup analysis (relevant to
question): MEP latency prolongation >0.8 occurred
in 72% of patients with L5 radiculopathy and 66%
with S1 radiculopathy

Author conclusions (relative to question): Subclinical


radiculopathy can be detected by motor EMG for L5
and S1 radiculopathy.

Thornbury Level IV Prospective Retrospective Critique of methodology


JR, Fryback Nonconsecutive patients
DG, Turski Type of Study Design: comparative Small sample size
PA, et al. evidence No universally-applied gold standard
Disk-Caused diagnostic Stated objective of study: to determine if MRI can No consistently applied gold standard
Nerve replace myelography or CT in the diagnosis of Poor reference standard/no gold standard
Compression lumbar herniated nucleus pulposus. applied
in Patients Lacked subgroup analysis
with Acute Diagnostic test(s) studied: Other: methodological limitations
Low-Back- Clinical exam/history
Pain - Electromyography
Diagnosis Myelogram Work group conclusions
with Mr, Ct MRI Potential Level: III
Myelography, CT Downgraded Level: IV
and Plain Ct. CT/Myelogram
Radiology. Other: Conclusions relative to question
Mar This paper provides evidence that: MRI, CT,
1993;186(3):7 Compared to: and CT myelography are all useful tools in the
31-738. Clinical exam/history diagnosis of lumbar disc herniation.
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: 22 had surgery

Gold standard used? Yes No


If so, what was the gold standard? 22 had surgery
Number of patients: 22/95

Consecutively assigned? Yes

Results/subgroup analysis (relevant to question): CT


was more reliable at identifying protruded discs
(100%) but the sample was only 5 patients. CT
myelogram was more reliable at diagnosing extruded
discs (83%) but the sample was only 6 patients. MRI
more often than not (66% of the time) correctly
identified protruded or extruded discs, but the
sample was only 11 patients. CT sensitivity was 94%
with a specificity of 64%; MRI sensitivity was 100%
with a specificity of 57%; CT myelography has a
sensitivity of 88% with a specificity of 57%.

Author conclusions (relative to question): MRI


should replace CT myelography, but not replace
plain CT.

Tullberg T, Level II Prospective Retrospective Critique of methodology


Svanborg E, Nonconsecutive patients
Isacsson J, Type of Study Design: case series Small sample size
Grane P. A evidence No universally-applied gold standard
preoperative diagnostic Stated objective of study: To determine the accuracy No consistently applied gold standard
and and value of EMGs in patients with herniated lumbar Poor reference standard/no gold standard
postoperative discs in terms of helping diagnose and direct applied
study of the treatment and evaluating patients post-operatively. Lacked subgroup analysis
accuracy and Other:
value of Diagnostic test(s) studied:
electrodiagno Clinical exam/history
sis in patients Electromyography Work group conclusions
with Myelogram Potential Level: I
lumbosacral MRI Downgraded Level: II
disc CT
herniation. CT/Myelogram Conclusions relative to question
Spine. Other: SEPs, This paper provides evidence that:
1993;18(7):83 electromyography has limited utility in the
7-842. Compared to: diagnosis of lumbar disc herniation with
Clinical exam/history radiculopathy.
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: surgery

Gold standard used? Yes No


If so, what was the gold standard? surgery

Number of patients: 20

Consecutively assigned? Yes

Results/subgroup analysis (relevant to


question): 65% of patients had some abnormal
electrophysiologic findings, but only 25% correlated
with CT localization

Author conclusions (relative to question): EMG is


not useful to diagnose the exact location of a
herniated lumbar disc but may be useful when
diagnostic studies and clinical findings disagree.
Question #5:
What is the role of pharmacological treatment in the management of lumbar disc herniation?

Article Level
(Alpha by of Description of study Conclusion
Author) evidence

Finckh A, Level I Prospective Retrospective Critique of methodology:


Zufferey P, Nonconsecutive patients
Schurch MA, Study design: RCT Nonrandomized
Balague F, Type of Nonmasked reviewers
Waldburger evidence Stated objective of study: To test the short-term efficacy of a Nonmasked patients
M, So AK. therapeutic single IV pulse of glucocorticosteroids on the symptoms of No validated outcome measures
Short-term acute discogenic sciatica. used
efficacy of Small sample size
intravenous Type of treatment(s): IV bolus of 500 mg of methylpredisolone <80% follow-up
pulse or normal saline. During the study all patients received Lacked subgroup analysis
glucocorticoi standard therapy (NSAID, tramadol, acetaminophen) and Diagnostic method not stated
ds in acute physical therapy. Some patients received additional treatment Other:
discogenic after three days.
sciatica. A
randomized Total number of patients: 60 Work group conclusions
controlled Number of patients in relevant subgroup(s): intravenous Potential Level: I
trial. Spine corticosteroid: 31 patients, intravenous saline: 29 patients Downgraded Level:
(Phila Pa
1976). Feb Consecutively assigned? No Conclusions relative to question
15 This paper provides evidence that:a
2006;31(4):3 Duration of follow-up: one, two, three, 10 and 30 days single IV infusion of glucocorticoids
77-381. provides only temporary (three days)
Validated outcome measures used (list): Primary: VAS relief of pain. A glucocorticoid bolus
sciatica. Secondary: VAS low back pain & global pain, McGill has no effect on functioning or
pain, ODI objective signs of radicular irritation
related to lumbar disc herniation.
Nonvalidated outcome measures used (list): signs of radicular
irritation

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): For the


primary outcome measure, the maximum mean VAS sciatic
scale improvement of 5.7 cm occurred on day one. None of
the secondary outcome measures was significantly different
between the two groups. As expected, no durable benefit was
observed at day 30 with a single intravenous bolus of
glucocorticoids for any outcome.

Author conclusions (relative to question): A single intravenous


pulse of glucocorticoid provides a small and transient
improvement in sciatic leg pain. The transient benefit and small
effect size of intravenous glucocorticoids on symptoms of
acute sciatica probably do not warrant a large clinical use in
this indication.

Genevay S, Level I Prospective Retrospective Critique of methodology:


Viatte S, Nonconsecutive patients
Finckh A, Study design: RCT Nonrandomized
Zufferey P, Type of Nonmasked reviewers
Balague F, evidence Stated objective of study: To assess the efficacy of Nonmasked patients
Gabay C. therapeutic adalimumab, a tumor necrosis factor alpha inhibitor, in patients No validated outcome measures
Adalimumab with radicular pain due to lumbar disc herniation. used
in severe Small sample size
and acute Type of treatment(s): Experimental group: adjuvant treatment <80% follow-up
sciatica: A with two subcutaneous injections of adalimumab at seven day Lacked subgroup analysis
multicenter, intervals. Placebo group: "matching control." Diagnostic method not stated
randomized, Other:
double-blind, Total number of patients: 61
placebo- Number of patients in relevant subgroup(s): Experimental
controlled group: 31, placebo group: 30 Work group conclusions
trial. Arthritis Potential Level: I
and Consecutively assigned? Yes Downgraded Level:
Rheumatism.
62(8):2339- Duration of follow-up: six months Conclusions relative to question
2346. This paper provides evidence that:in
Validated outcome measures used (list): Primary: VAS leg contrast to the authors' conclusion, a
pain. Secondary: VAS low back pain, ODI, SF-12. subcutaneous injection of adalimumab
does not result in overall improvement
Nonvalidated outcome measures used (list): surgery, work at six weeks or six months, relative to
status, drug use. Unconventional use of validated outcome placebo. The authors utilized
tools: defined "responders" as having VAS scores for leg pain nonvalidated interpretation of outcome
and back pain or ODI improved by > 30%, without having measures to support their conclusion
surgery. "Low Residual Disease" was defined by VAS 0-20, that treatment was effective, however,
without surgery; ODI 20. when evaluating the VAS, ODI and
SF-12 there was overlap in confidence
Diagnosis made by: intervals.
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Leg pain: A


significant, small effect size is reported in favor of the
experimental group on days one and two after treatment. On
these days, the two groups' confidence intervals overlap. At
six months the number of patients meeting the "Responder"
and "Low Residual Disease" criteria was significantly greater in
the experimental group. Back pain: At six months the number
of patients meeting the "Responder" criteria was significantly
greater in the experimental group. Surgery:
Experimental/Placebo: week six - 1/5; week 24- 6/13.
Author conclusions (relative to question): A short course of
adalimumab added to the treatment regimen of patients
experiencing acute and severe sciatica resulted in a small
decrease in leg pain and significantly fewer surgical
procedures.

Kanayama Level II Prospective Retrospective Critique of methodology:


M, Nonconsecutive patients
Hashimoto T, Study design: RCT Nonrandomized
Shigenobu Type of Nonmasked reviewers
K, Oha F, evidence Stated objective of study: Evaluate the efficacy of the 5-HT Nonmasked patients
Yamane S. therapeutic receptor inhibitor in the treatment of symptomatic lumbar disc No validated outcome measures
New herniation. used
treatment of Small sample size
lumbar disc Type of treatment(s): Treatment group: oral 5-HT receptor <80% follow-up
herniation inhibitor daily for two weeks. Control group: oral diclofenac Lacked subgroup analysis
involving 5- daily for two weeks. Diagnostic method not stated
hydroxytrypt Other: After the second week study
amine2A Total number of patients: 40 patients were allowed to choose other
receptor Number of patients in relevant subgroup(s): 20 treatment including medications and
inhibitor: a injections.
randomized Consecutively assigned? Yes
controlled
trial. J Duration of follow-up: Primary end-point: two weeks; additional Work group conclusions
Neurosurg treatment greater than one year Potential Level: II
Spine. Apr Downgraded Level:
2005;2(4):44 Validated outcome measures used (list): VAS (overall
1-446. percentage of improvement) Conclusions relative to question
This paper provides evidence that:at
Nonvalidated outcome measures used (list): additional health two weeks, 5-HT receptor inhibitors
care and diclofenac provide comparable
relief from low back pain, leg pain and
Diagnosis made by: leg numbness due to lumbar disc
Clinical exam/history herniation.
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): The mean


VAS improvement rates in the 5-HT inhibitor and diclofenac
groups were 33% and 46% for low back pain, 32% and 32%
for leg pain, 35% and 32% for leg numbness, respectively.
There was no statistical difference between the two groups.
No additional medical interventions were required in 50% of
the 5-HT receptor inhibitor treated patients and 15% of those
receiving diclofenac. Surgery was required in 20% of the 5-HT
receptor inhibitor group and 30% of the NSAID group.

Author conclusions (relative to question): The study


demonstrated that the efficacy of 5-HT receptor inhibitor was
comparable with that of NSAID in the treatment of symptomatic
lumbar disc herniation.

Kasimcan O, Level IV Prospective Retrospective Critique of methodology:


Kaptan H. Nonconsecutive patients
Efficacy of Study design: case series Nonrandomized
gabapentin Type of Nonmasked reviewers
for evidence Stated objective of study: To analyze the effects of gabapentin Nonmasked patients
radiculopathy therapeutic on reduction of the severity of radicular pain and improvement No validated outcome measures
caused by of quality of life in patients with lumbar disc herniation and /or used
lumbar spinal lumbar spinal stenosis over a relatively short period. Small sample size
stenosis and <80% follow-up
lumbar disk Type of treatment(s): Titration of gabapentin three times daily Lacked subgroup analysis
hernia. to a maximum dose of 2400 mg/day Diagnostic method not stated
Neurol Med Other: short duration; no control
Chir Total number of patients: 78 including lumbar spinal stenosis group
(Tokyo).50(1 patients)
2):1070- Number of patients in relevant subgroup(s): 33
1073. Work group conclusions
Consecutively assigned? No Potential Level: IV
Downgraded Level:
Duration of follow-up: 3 months
Conclusions relative to question
Validated outcome measures used (list): VAS radicular pain This paper provides evidence
that:gabapentin three times daily
Nonvalidated outcome measures used (list): Odom's criteria, titrated to a maximum dose of 2400
walking distance mg/day can significantly reduce
radicular pain and improve function.
Diagnosis made by:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Mean scores


for VAS, walking distance and Odom's criteria all showed a
statistically significant improvement at three months compared
to baseline. Walking distance improved from 0-100 m in 29
patients to 1000 m in 24 patients at three months. Odom's
criteria was good or excellent in 28 patients at three months.

Author conclusions (relative to question): Gabapentin


monotherapy can reduce pain and increase walking distance
significantly in in patients with lumbar disc herniation.

Keynan O, Level II Prospective Retrospective Critique of methodology:


Mirovsky Y, Nonconsecutive patients
Dekel S, Study design: RCT Nonrandomized
Gilad VH, Type of Nonmasked reviewers
Gilad GM. evidence Stated objective of study: To evaluate the therapeutic efficacy Nonmasked patients
Safety and therapeutic of agmatine sulfate in patients with herniated lumbar disc No validated outcome measures
efficacy of associated radiculopathy. used
dietary Small sample size
agmatine Type of treatment(s): Treatment group: 14 day course of 2,670 <80% follow-up
sulfate in grams /day of oral agmantine sulfate. Placebo group: identical Lacked subgroup analysis
lumbar disc- capsules of indigestible dietary fiber. Concomitant treatment Diagnostic method not stated
associated permitted: physical therapy, medication, epidural steroid Other:
radiculopathy injections, discectomy.
. An open-
label, dose- Total number of patients: 99 Work group conclusions
escalating Number of patients in relevant subgroup(s): treatment group: Potential Level: II
study 31, placebo group: 30 Downgraded Level:
followed by a
randomized, Consecutively assigned? Yes Conclusions relative to question
double-blind, This paper provides evidence that:a
placebo- Duration of follow-up: two months two week treatment of agmatine is
controlled more effective than placebo in
trial. Pain Validated outcome measures used (list): VAS back and leg treatment of lumbar disc herniation
Medicine.11( pain, McGill Pain, ODI, SF-36. with radiculopathy. The therapeutic
3):356-368. efficacy is not demonstrated beyond
Nonvalidated outcome measures used (list): the 20 day follow-up.

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Symptoms


improved in both groups over time. In the period immediately
following treatment, at 15-20 days, statistically significantly
enhanced improvements were seen in the treatment group
compared to the placebo group. At 45-50 days and 75-80 days
the difference between treatment and placebo group did not
meet statistical significance. There was no significant
difference in the use of physical therapy, medication, epidural
steroid injections and discectomy between the groups.

Author conclusions (relative to question): During the period


immediately after taking agmatine sulfate, people suffering
from lumbar disc associated radiculopathy undergo significant
improvement in their symptoms and general health-related
quality of life as compared to those taking placebo.

Korhonen T, Level II Prospective Retrospective Critique of methodology:


Karppinen J, Nonconsecutive patients
Paimela L, et Study design: RCT Nonrandomized
al. The Type of Nonmasked reviewers
treatment of evidence Stated objective of study: To evaluate the long term efficacy of Nonmasked patients
disc- therapeutic infliximab in patients with acute/subacute sciatica secondary to No validated outcome measures
herniation- herniated disc. used
induced Small sample size
sciatica with Type of treatment(s): treatment group: intravenous infliximab, <80% follow-up
infliximab: 5 mg/kg; Lacked subgroup analysis
one-year placebo group: saline infusion Diagnostic method not stated
follow-up Other:
results of Total number of patients: 40
FIRST II, a Number of patients in relevant subgroup(s):
randomized treatment group: 21, placebo group: 19. Work group conclusions
controlled Potential Level: I
trial. Spine. Consecutively assigned? Yes Downgraded Level: II
2006(24):275
9-2766. Duration of follow-up: one year Conclusions relative to question
http://www.m This paper provides evidence that:A
rw.interscien Validated outcome measures used (list): VAS leg and back single intravenous dose of infliximab is
ce.wiley.com pain, ODI, RAND 36 not superior to placebo for the
/cochrane/clc treatment of radiculopathy due to
entral/articles Nonvalidated outcome measures used (list): time to response lumbar disc herniation at one year.
/732/CN- (>75% leg pain reduction); number of discectomies; reduction
00573732/fra of straight leg restriction; differences in reflexes, sensory, sick
me.html. leaves.
Diagnosis made by:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): There was


no clinically significant difference in leg or back pain (VAS),
>75% pain reduction, Health-Related QOL, or SLR.

Author conclusions (relative to question): We cannot


recommend the clinical use of infliximab in disc herniation
induced sciatica.

Korhonen T, Level II Prospective Retrospective Critique of methodology:


Karppinen J, Nonconsecutive patients
Paimela L, et Study design: RCT Nonrandomized
al. The Type of Nonmasked reviewers
treatment of evidence Stated objective of study: To evaluate the efficacy of infliximab, Nonmasked patients
disc therapeutic a monoclonal antibody against tumor necrosis factor (TNF)- No validated outcome measures
herniation- alpha in a randomized controlled setting. used
induced Small sample size
sciatica with Type of treatment(s): treatment group: infliximab, 5 mg/kg <80% follow-up
infliximab: single infusion; Lacked subgroup analysis
results of a control group: saline infusion. Diagnostic method not stated
randomized, Other:
controlled, 3- Total number of patients: 40
month follow- Number of patients in relevant subgroup(s): treatment group:
up study. 21, control group: 19 Work group conclusions
Spine. Potential Level: I
2005(24):272 Consecutively assigned? Yes Downgraded Level: II
4-2728.
http://www.m Duration of follow-up: three months Conclusions relative to question
rw.interscien This paper provides evidence that:A
ce.wiley.com Validated outcome measures used (list): Primary: VAS leg single intravenous dose of infliximab
/cochrane/clc pain. 5mg/kg is no better than a placebo for
entral/articles Secondary: VAS back pain, ODI the treatment of sciatica due to lumbar
/816/CN- disc herniation at 12 weeks.
00561816/fra Nonvalidated outcome measures used (list): Improvement of
me.html. straight leg raise restriction, sick leave, discectomies.

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): There was


no clinically significant difference between the treatment and
placebo groups in back or leg pain, ODI or sick leave.

Author conclusions (relative to question): Results do not


support the use of a single infusion of infliximab 5 mg/kg to
treat moderate to severe disc herniation induced sciatica.

Pirbudak L, Level I Prospective Retrospective Critique of methodology:


Karakurum Nonconsecutive patients
G, Oner U, Study design: RCT Nonrandomized
Gulec A, Type of Nonmasked reviewers
Karadasli H. evidence Stated objective of study: To determine the efficacy of Nonmasked patients
Epidural therapeutic amitriptyline as an adjunct to epidural steroid injections in the No validated outcome measures
corticosteroid management of chronic lumbar radicular pain. used
injection and Small sample size
amitriptyline Type of treatment(s): All patients received a blind interlaminar <80% follow-up
for the epidural injection at the involved level with 10 ml solution of Lacked subgroup analysis
treatment of betamethasone dipropionate (10mg) + betamethasone sodium Diagnostic method not stated
chronic low phosphate (4mg) + bupivacaine (0.25%). In addition, a postural Other:
back pain exercise program was initiated during the follow-up period.
associated The injection was repeated at the end of the second week, if
with the improvement was partial, and at the end of the sixth week, Work group conclusions
radiculopathy if there was still incomplete recovery. Potential Level: I
. Pain Clin. Downgraded Level:
2003;15(3):2 Treatment group: 10mg/day amitryptiline orally (may be titrated
47-253. up to 50mg/day according to clinical response) for nine Conclusions relative to question
months. This paper provides evidence that:the
addition of amitriptyline to blind lumbar
Control group: Placebo (sugar) tablets instead of amitryptiline. interlaminar epidural steroid injections
provides significant relief as compared
Total number of patients: 92 with placebo and interlaminar epidural
Number of patients in relevant subgroup(s): 46 steroid injections at up to nine months.

Consecutively assigned? No

Duration of follow-up: nine months (two weeks, six weeks,


three months, six months, nine months).

Validated outcome measures used (list): VAS, ODI

Nonvalidated outcome measures used (list): Self-rating


(complete recovery, partial recovery, no recovery at all)

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: Inclusion criteria: chronic LBP of at least three
months' duration not responding to other conservative
modalities (NSAIDs, physical, bracing, etc.); unilateral radicular
pain; lumbar nerve root compression on MRI, which indicates
disc herniation corresponding to the clinical symptoms; age
greater than 35 years

Results/subgroup analysis (relevant to question): Six months


and nine months results: The placebo group outcomes did not
differ statistically when compared with baseline values. The
amitryptiline group experienced statistically significant
improvements compared with baseline values (p=0.002) and
when compared with the placebo group.

Author conclusions (relative to question): The study showed


that epidural steroid and amitryptiline combination proved
beneficial in the management of chronic low back pain
associated with radiculopathy.
Question #6:
What is the role of physical therapy/exercise in the treatment of lumbar disc herniation?

Article Level
(Alpha by of Description of study Conclusion
Author) evidence

Bakhtiary Level II Prospective Retrospective Critique of methodology:


AH, Safavi- Nonconsecutive patients
Farokhi Z, Study design: RCT Nonrandomized
Rezasoltani Type of Nonmasked reviewers
A. Lumbar evidence Stated objective of study: To investigate the effect of Nonmasked patients
stabilizing therapeutic lumbar stabilizing exercise (LSE) in patients with LDH. No validated outcome measures used
exercises Small sample size
improve Type of treatment(s): Crossover Design. <80% follow-up
activities of Group A: four weeks LSE; followed by four weeks of no Lacked subgroup analysis
daily living in exercise. Diagnostic method not stated
patients with Group B: four weeks of no exercise; followed by four Other: Low baseline pain values; no
lumbar disc weeks of LSE. The LSE protocol included four stages of stated primary outcome measure
herniation. stabilizing exercises from easy to advanced.
J Back
Musculoskel Total number of patients: 60 Work group conclusions
etal Rehabil Number of patients in relevant subgroup(s): Group A: 30; Potential Level: I
2005;18:55 Group B: 30 Downgraded Level: II
60.
Consecutively assigned? Conclusions relative to question
This paper provides evidence that:four
Duration of follow-up: 8 weeks (0, 4 and 8 weeks) weeks of lumbar stabilization exercise
results in decreased pain and improved
Validated outcome measures used (list): VAS function in patients with lumbar disc
herniation with radiculopathy.
Nonvalidated outcome measures used (list): range of
trunk flexion; range of left and right straight leg raise; time
required to complete the following activities of daily living
(ADL): laying prone on the floor from standing position,
standing up from laying prone on the floor, climbing steps
[five steps], 10 meter walking [as fast as they can, without
pain]

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: Inclusion criteria: LDH at L4-5 or L5-S1
confirmed on CT or MRI; history of LBP, sciatic pain and
reduced functional performance for more than two
months.

Results/subgroup analysis (relevant to


question): Significant differences between groups A and
B were seen in the mean changes on all outcome
measures at the end of four weeks. After crossover, there
were no significant differences between the groups in any
of the outcomes measured at eight weeks.

Author conclusions (relative to question): This clinical trial


showed that a lumbar stabilizing exercise protocol may
increase lumbar stability and improve ADL performance in
patients who have suffered with a herniated lumbar disc
for more than two months. The results of this study may
encourage physiotherapists to use LSE to treat patients
with lumbar herniated disc.

Thackeray A, Level III Prospective Retrospective Critique of methodology:


Fritz JM, Nonconsecutive patients
Brennan GP, Study design: RCT Nonrandomized
Zaman FM, Type of Nonmasked reviewers
Willick SE. A evidence Stated objective of study: To investigate the therapeutic Nonmasked patients
pilot study therapeutic outcomes of physical therapy after selective nerve root No validated outcome measures used
examining blocks (SNRB) and of SNRBs alone in people with LBP Small sample size
the and sciatica due to disc herniation. <80% follow-up
effectiveness Lacked subgroup analysis
of physical Type of treatment(s): Control group: SNRB; Treatment Diagnostic method not stated
therapy as group: SNRB+ physical therapy (end-range directional Other:
an adjunct to exercises; +/- mechanical traction; strengthening;
selective flexibility; stabilization; cardiovascular)
nerve root Work group conclusions
block in the Total number of patients: 44 Potential Level: II
treatment of Number of patients in relevant subgroup(s): Downgraded Level: III
lumbar Control group: 23; Treatment group: 21.
radicular Conclusions relative to question
pain from Consecutively assigned? This paper provides evidence
disk that:supervised exercises intended to
herniation: a Duration of follow-up: six months reduce symptoms after SNRBs were no
randomized more beneficial than SNRBs alone.
controlled Validated outcome measures used (list): Primary: Low
trial. Phys Back Pain Disability Questionnaire (DISQ); numeric pain
Ther. rating scale (NPRS)
Dec;90(12):1
717-1729. Nonvalidated outcome measures used (list): Global
Rating of Change (GROC), Fear Avoidance Belief
Questionnaire, Sciatic Bothersome Index, body pain
diagram

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: Inclusion criteria: LDH on MRI within six months
of baseline examination consistent with the patient's
symptoms; scheduled to receive transforaminal SNRB
within two weeks of baseline examination; between 18-60
years old; pain, paresthesia or both in the lumbar spine,
extending distal to the gluteal fold, within 24 hours of
enrollment.

Results/subgroup analysis (relevant to


question): Intention -to- treat analysis (adjusted) and as-
treated analysis both show no significant difference in
outcomes between the control and treatment groups.

Author conclusions (relative to question): The results of


this pilot study failed to show that physical therapy
interventions, intended to centralize symptoms after
SNRBs, were more beneficial than SNRBs alone.
Question #7:
What is the role of spinal manipulation in the treatment of lumbar disc herniation?

Article Level
(Alpha by of Description of study Conclusion
Author) evidence

Burton AK, Level III Prospective Retrospective Critique of methodology:


Tillotson KM, Nonconsecutive patients
Cleary J. Study design: RCT Nonrandomized
Single-blind Type of Nonmasked reviewers
randomised evidence Stated objective of study: To test the hypothesis that Nonmasked patients
controlled therapeutic manipulative treatment provides at least equivalent 12 month No validated outcome measures
trial of outcomes when compared with treatment by chemonucleolysis used
chemonucleo for patients with sciatica due to confirmed lumbar disc Small sample size
lysis and herniation. <80% follow-up
manipulation Lacked subgroup analysis
in the Type of treatment(s): Control group: chemonucleolysis Diagnostic method not stated
treatment of Treatment group: manipulation Other:
symptomatic
lumbar disc Total number of patients: 40
herniation. Number of patients in relevant subgroup(s): Control:20; Work group conclusions
Eur Spine J Treatment:20 Potential Level: II
2000;9:202- Downgraded Level: III
7. Consecutively assigned? No
Conclusions relative to question
Duration of follow-up: 12 months This paper provides evidence that:
Level III that spinal manipulation is as
Validated outcome measures used (list): Roland Morris effective as chemonucleolysis in
Disability Questionnaire patients without clear indications for
surgical intervention.
Nonvalidated outcome measures used (list): pain thermometer
(back & leg); lumbar range of motion Level IV: Spinal manipulation is
beneficial in treating patients with
Diagnosis made by: lumbar disc herniation with
Clinical exam/history radiculopathy.
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): By 12


months both groups had significant improvement in mean
scores on back and leg pain and Roland Morris without
significant differences between groups.

Author conclusions (relative to question): Osteopathic


manipulation can be considered a safe and effective treatment
option for patients with a lumbar radicular syndrome due to
LDH, in the absence of clear indications for surgical
intervention.

McMorland Level IV Prospective Retrospective Critique of methodology:


G, Suter E, Nonconsecutive patients
Casha S, du Study design: RCT Nonrandomized
Plessis SJ, Type of Nonmasked reviewers
Hurlbert RJ. evidence Stated objective of study: To compare the clinical efficacy of Nonmasked patients
Manipulation therapeutic spinal manipulation against microdiscectomy in patients with No validated outcome measures
or sciatica secondary to LDH. used
microdiskect Small sample size
omy for Type of treatment(s): Control group: microdiscectomy. <80% follow-up
sciatica? A Treatment group: spinal manipulative therapies Lacked subgroup analysis
prospective Diagnostic method not stated
randomized Total number of patients: 40 Other:
clinical study. Number of patients in relevant subgroup(s): 20
J
Manipulative Consecutively assigned? Yes Work group conclusions
Physiol Ther. Potential Level: IV
Oct;33(8):57 Duration of follow-up: 12 weeks, one year Downgraded Level:
6-584.
Validated outcome measures used (list): SF-36, McGill Pain Conclusions relative to question
Questionnaire, Aberdeen Back Pain Scale, Roland-Morris. This paper provides evidence
that:spinal manipulation is beneficial in
Nonvalidated outcome measures used (list): treating patients with lumbar disc
herniation with radiculopathy.
Diagnosis made by:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): 60% of


patients with lumbar radiculopathy due to LDH who fail three
months of medical management will obtain comparable relief to
those patients that undergo successful surgery.

Author conclusions (relative to question): Of patients with


sciatica that fail three months of medical management, 60%
benefit from spinal manipulation to the same degree as if they
undergo surgical intervention. For the 40% that are unsatisfied,
surgery provides an excellent outcome.

Santilli V, Level I Prospective Retrospective Critique of methodology:


Beghi E, Nonconsecutive patients
Finucci S. Study design: RCT Nonrandomized
Chiropractic Type of Nonmasked reviewers
manipulation evidence Stated objective of study: To assess the short-and long-term Nonmasked patients
in the therapeutic effects of spinal manipulation on acute back pain and sciatica No validated outcome measures
treatment of with disc protrusion. used
acute back Small sample size
pain and Type of treatment(s): spinal manipulation vs. sham <80% follow-up
sciatica with manipulation. Lacked subgroup analysis
disc Diagnostic method not stated
protrusion: a Total number of patients: 102 Other:
randomized Number of patients in relevant subgroup(s): spinal
double-blind manipulation: 53 patients; sham manipulation: 49 patients
clinical trial Work group conclusions
of active and Consecutively assigned? Yes Potential Level: I
simulated Downgraded Level:
spinal Duration of follow-up: 180 days
manipulation Conclusions relative to question
s. Spine J. Validated outcome measures used (list): VAS 1 (back & This paper provides evidence
Mar-Apr buttock ) & VAS 2 (leg), SF-36 that:spinal manipulation is significantly
2006;6(2):13 more effective than sham treatment for
1-137. Nonvalidated outcome measures used (list): Disc morphology, the relief of back and leg pain due to
Kellner Rating (psychological profile) acute (less than 10 days) lumbar disc
herniation with radiculopathy.
Diagnosis made by:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): A


significantly greater number of patients treated with spinal
manipulation had no back, buttock or leg pain at 180 days.
VAS 1: 28% vs. 6 %. VAS 2: 55% vs. 20%. There was no
significant difference in the SF-36, psychological testing and
disc morphology between the groups.

Author conclusions (relative to question): Active spinal


manipulations have more effect than simulated manipulations
on pain relief for acute back pain and sciatica with disc
protrusion.
Question #8:
What is the role of traction (manual or mechanical) in the treatment of lumbar disc herniation?

Article Level
(Alpha by of Description of study Conclusion
Author) evidence

Unlu Z, Tascl Level II Prospective Retrospective Critique of methodology:


S, Tarhan S, Nonconsecutive patients
Pabuscu Y, Study design: RCT Nonrandomized
Islak S. Type of Nonmasked reviewers
Comparison evidence Stated objective of study: Compare the outcomes of traction, Nonmasked patients
of 3 physical therapeutic ultrasound (US), and low power laser (LPL) therapies in No validated outcome measures
therapy patients with acute lower back pain and leg pain caused by used
modalities for LDH. Small sample size
acute pain in <80% follow-up
lumbar disc Type of treatment(s): mechanical traction with 35-50% body Lacked subgroup analysis
herniation weight, ultrasound, LPL Diagnostic method not stated
measured by Other: randomization method not
clinical Total number of patients: 60 stated.
evaluation Number of patients in relevant subgroup(s): 20
and
magnetic Consecutively assigned? Yes Work group conclusions
resonance Potential Level: I
imaging. J. Duration of follow-up: three months Downgraded Level: II
Manip.
Physiol. Validated outcome measures used (list): VAS; ODI; Roland- Conclusions relative to question
Ther. Mar- Morris; This paper provides evidence that:
Apr Level II evidence that pain and
2008;31(3):1 Nonvalidated outcome measures used (list): clinical signs; MRI disability due to acute lumbar
91-198. disc morphology radiculopathy secondary to lumbar disc
herniation may improve over three
Diagnosis made by: months in patients undergoing
Clinical exam/history mechanical traction with 35-50% body
Electromyography weight, however it is equal in
Myelogram effectiveness to low power laser and
MRI ultrasound.
CT
CT/Myelogram Level IV evidence that pain and
Other: disability due to acute lumbar
radiculopathy secondary to LDH may
improve over three months in patients
Results/subgroup analysis (relevant to question): There were undergoing mechanical traction with
significant reductions in pain and disability scores between 35-50% body weight.
baseline and follow-up in all three groups. There was a
significant reduction in the size of the disc herniation on MRI
after treatment. There was no correlation between clinical
findings, pain and disability scores, and change in LDH size.

Author conclusions (relative to question): Traction, ultrasound,


and LPL therapies were all effective in the treatment of this
group of patients with acute LDH.
Question #9:
a. What is the role of epidural steroid injections for the treatment of lumbar disc herniation?
b. Is there an optimal frequency or quantity of injections for the treatment of lumbar disc herniations?
c. Does the approach (interlaminar, transforaminal, caudal) influence the risks or effectiveness of epidural steroid
injections in the treatment of lumbar disc herniations?

Article Level
(Alpha by of Description of study Conclusion
Author) evidence

Ackerman Level I Prospective Retrospective Critique of methodology:


WE, Ahmad Nonconsecutive patients
M. The Study design: RCT Nonrandomized
efficacy of Type of Nonmasked reviewers
lumbar evidence Stated objective of study: To test the null hypothesis that Nonmasked patients
epidural therapeutic these three methods of lumbar epidural steroid injections No validated outcome measures
steroid (caudal, interlaminar, transforaminal) are equally effective for used
injections in the management of radicular pain associated with lumbar Small sample size
patients with disc herniation at L5-S1. <80% follow-up
lumbar disc Lacked subgroup analysis
herniations. Type of treatment(s): Epidural steroid injection: Caudal, Diagnostic method not stated
Anesth. Interlaminar, Transforaminal Other: volumes of injections varied
Analg. May
2007;104(5): Total number of patients: 90
1217-1222. Number of patients in relevant subgroup(s): 30 in each Work group conclusions
subgroup Potential Level: I
(caudal, interlaminar, transforaminal) Downgraded Level:

Consecutively assigned? Yes Conclusions relative to question


This paper provides evidence
Duration of follow-up: 24 weeks that:transforaminal injections are more
effective than caudal or interlaminar
Validated outcome measures used (list): Oswestry Low injections in the treatment of patients
Back Pain Disability Scale, Beck Depression Score, Numeric with lumbar disc herniation with
Pain Intensity Score radiculopathy.

Nonvalidated outcome measures used (list):


Diagnosis made by:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question):


(A) Pain scores improved in all groups. All groups showed
significant improvement in functional and depression
outcome measures two weeks following their last treatment.

(B) Patients had an average of 1.5, 2.2 and 2.5 injections in


the transforaminal, interlaminar, and caudal groups,
respectively.

(C) Pain scores improved in all groups but were significantly


lower in the transforaminal group. At 24 weeks the
transforaminal epidural steroid group had significantly more
patients reporting complete (30%) or partial relief (53%). At
24 weeks, complete or partial pain relief in the
transforaminal, interlaminar, and caudal groups was
reported in 25, 18, and 17 patients respectively. All groups
showed significant improvement in functional and depression
outcome measures two weeks after their last injection.
However, no differences were noted between groups in the
depression and functional outcomes.

Author conclusions (relative to question): The transforaminal


approach offers the benefit of increased analgesic efficacy
compared to the caudal and interlaminar approaches.

Ghahreman Level I Prospective Retrospective Critique of methodology:


A, Ferch R, Nonconsecutive patients
Bogduk N. Study design: RCT Nonrandomized
The Efficacy Type of Nonmasked reviewers
of evidence Stated objective of study: To determine the efficacy of Nonmasked patients
Transforamin therapeutic transforaminal injection of steroid and local anesthetic, local No validated outcome measures
al Injection of anesthetic alone, normal saline alone, intramuscular injection used
Steroids for of steroid or normal saline on radicular pain secondary to Small sample size
the lumbar disc herniation. <80% follow-up
Treatment of Lacked subgroup analysis
Lumbar Type of treatment(s): Ganglionic approach to deliver Diagnostic method not stated
Radicular transforaminal injection of steroid and local anesthetic, local Other:
Pain. Pain anesthetic, or normal saline. Intramuscular injection of
Med.;11(8):1 steroid or normal saline.
149-1168. Work group conclusions
Total number of patients: 150 Potential Level: I
Number of patients in relevant subgroup(s): transforaminal Downgraded Level:
steroid and local anesthetic: 28; transforaminal local
anesthetic: 27; transforaminal normal saline: 37; Conclusions relative to question
intramuscular steroid: 30; intramuscular normal saline: 28. This paper provides evidence
that:transforaminal epidural steroid
Consecutively assigned? Yes injection is an effective treatment for a
proportion of patients with symptomatic
Duration of follow-up: one month and 12 month follow-up lumbar disc herniations and is superior
to intramuscular saline, intramuscular
Validated outcome measures used (list): Numeric Rating steroids, transforaminal saline, and
Scale, Roland-Morris, SF-36. transforaminal local anesthetics for
short-term (30 days) pain relief and
Nonvalidated outcome measures used (list): Proportion of functional improvement.
patients who underwent each treatment who obtained
complete relief or at least 50% relief of pain for at least one
month after treatment, Patient- Specified Functional Outcome
Scale; use of other healthcare, duration of relief, proportion of
patients who required rescue treatment or surgery.

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question):


(A) 54% of transforaminal epidural steroid group experienced
>50% radicular pain relief at one month after treatment (CI
0.36-0.72). This outcome was statistically significant
compared to the transforaminal normal saline, transforaminal
local anesthetic, intramuscular normal saline and
intramuscular steroid groups. The transforaminal steroid
group had concomitant improvements in function and
disability.

(B) The transforaminal epidural steroid injectate of 2.5 m was


comprised of 70 mg triamcinolone and 0.75 ml of 5%
bupivacaine. No variation in dosage or frequency could be
determined to affect the outcomes. Patients who did not
obtain relief from the first transforaminal epidural steroid
injection were offered a second "rescue" transforaminal
epidural steroid injection. Among the patients who accepted
a rescue transforaminal epidural steroid injection, 50%
obtained relief.

C)Transforaminal steroid injection was found to be more


effective than intramuscular steroid injection for the treatment
of lumbar radiculopathy secondary to lumbar disc herniation.
No discrete complications from the injections were identified.

Author conclusions (relative to question): Transforaminal


epidural steroid injection is a viable alternative to surgery for
lumbar radicular pain due to disc herniation. Its immediate
yield is modest , but substantial, and not a placebo effect. For
long-term efficacy, proof beyond a reasonable doubt would
require prohibitively large studies.

Karppinen J, Level I Prospective Retrospective Critique of methodology:


Malmivaara Nonconsecutive patients
A, Kurunlahti Study design: RCT Nonrandomized
M, et al. Type of Nonmasked reviewers
Periradicular evidence Stated objective of study: The purpose of the study was to Nonmasked patients
infiltration for therapeutic test the efficacy of periradicular corticosteroid injection for No validated outcome measures
sciatica: a sciatica. used
randomized Small sample size
controlled Type of treatment(s): Treatment group: single <80% follow-up
trial. Spine transforaminal epidural steroid injection. Control Lacked subgroup analysis
(Phila Pa group:Transforaminal injection of normal saline Diagnostic method not stated
1976). May 1 Other:
2001;26(9):1 Total number of patients: 160
059-1067. Number of patients in relevant subgroup(s): Steroid: 80,
Saline: 80 Work group conclusions
Potential Level: I
Consecutively assigned? Yes Downgraded Level:

Duration of follow-up: two months Conclusions relative to question


This paper provides evidence
Validated outcome measures used (list): Visual Analog that:transforaminal epidural steroid
Scale Leg Pain (primary outcome); Oswestry Low Back injection is an effective treatment for a
Disability Questionnaire; Nottingham Health Profile proportion of patients with symptomatic
lumbar disc herniations, as compared
Nonvalidated outcome measures used (list): with saline injection, for short-term (four
weeks) pain relief.
Diagnosis made by:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:
Results/subgroup analysis (relevant to question): Contained
Disc Herniations: Transforaminal epidural steroid injections
were significantly better for leg pain at four weeks and
Nottingham Health Profile emotional scores at three months,
compared to transforaminal normal saline.

Author conclusions (relative to question): Transforaminal


epidural steroid injection is superior to transforaminal normal
saline injection for treatment of leg pain due to most
contained disc herniations.

Karppinen J, Level I Prospective Retrospective Critique of methodology:


Ohinmaa A, Nonconsecutive patients
Malmivaara Study design: RCT Nonrandomized
A, et al. Cost Type of Nonmasked reviewers
effectiveness evidence Stated objective of study: To describe the efficacy and cost- Nonmasked patients
of therapeutic effectiveness of periradicular infiltration with steroid in No validated outcome measures
periradicular subgroups of patients with sciatica. used
infiltration for Small sample size
sciatica: Type of treatment(s): Treatment group: single <80% follow-up
subgroup transforaminal epidural steroid injection. Control group: Lacked subgroup analysis
analysis of a transforaminal injection of normal saline. Diagnostic method not stated
randomized Other:
controlled Total number of patients: 160
trial. Spine Number of patients in relevant subgroup(s): Transforaminal
(Phila Pa epidural steroid injection/Transforaminal normal saline Work group conclusions
1976). Dec 1 injection: Bulges:18/11; Contained: 24/26; Extrusions: 38/43. Potential Level: I
2001;26(23): Downgraded Level:
2587-2595. Consecutively assigned? Yes
Conclusions relative to question
Duration of follow-up: 12 months This paper provides evidence
that:transforaminal epidural steroid
Validated outcome measures used (list): Visual Analog injection is an effective treatment for a
Scale leg (primary outcome); Oswestry Low Back Disability proportion of patients with symptomatic
Questionnaire; Nottingham Health Profile lumbar disc herniations, as compared
with saline injection, for short-term (four
Nonvalidated outcome measures used (list): Cost- weeks) pain relief.
effectiveness

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question):


(A) Bulges: There was no known significant differences
between the treatments. Extrusions: There was significant
improvement with transforaminal normal saline at six months.
Contained: Transforaminal epidural steroid injections were
significantly better for leg pain at four weeks, and Nottingham
Health Profile emotional scores at three months. Area under
the curve was significantly better with transforaminal epidural
steroid injection for Visual Analog Scale and Nottingham
Health Profile from baseline to three months post treatment.

(B) ) Only one injection, no booster injections allowed.


Volume was 2 ml for L4 and L5 and 3 ml for S1 root levels.

(C) Only 1 approach, transforaminal, was used and all were


done with fluoroscopy with contrast to confirm (ie
neurogram).

Author conclusions (relative to question): Transforaminal


epidural steroid injection is superior to transforaminal normal
saline injection for treatment of leg pain due to most
contained disc herniations and resulted in saved medical
costs due to contained lumbar disc herniation. For
extrusions, steroid appears counter-effective.

Kolsi I, Level III Prospective Retrospective Critique of methodology:


Delecrin J, Nonconsecutive patients
Berthelot JM, Study design: RCT Nonrandomized
Thomas L, Type of Nonmasked reviewers
Prost A, evidence Stated objective of study: Compare the short-term efficacy on Nonmasked patients
Maugars Y. therapeutic pain and functional impairment of nerve root sheath (NRS) No validated outcome measures
Efficacy of vs. interspinous (ISS) glucocorticoid injection. used
nerve root Small sample size
versus Type of treatment(s): NRS/ISS <80% follow-up
interspinous Lacked subgroup analysis
injections of Total number of patients: 30 Diagnostic method not stated
glucocorticoi Number of patients in relevant subgroup(s): NRS 17; ISS 13 Other: improper randomization
ds in the
treatment of Consecutively assigned? No
disk-related Work group conclusions
sciatica. A Duration of follow-up: 28 days; Late follow-up average eight Potential Level: II
pilot, months Downgraded Level: III
prospective,
randomized, Validated outcome measures used (list): VAS; Roland- Conclusions relative to question
double-blind Morris This paper provides evidence that:nerve
study. Joint root sheath and interspinous
Bone Spine. Nonvalidated outcome measures used (list): Surgery glucocorticoid injection are comparably
2000;67(2):1 effective in the treatment of lumbar disc
13-118. Diagnosis made by: herniation with radiculopathy.
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Both


treatment groups had improvement in their pain and disability
with no significant difference between treatment groups. At
the eight month follow-up, three patients in each group had
surgery, and the remainder of the patients were pain free.

Author conclusions (relative to question): Whether NRS is


superior to ISS remains to be proven.

Manchikanti Level III Prospective Retrospective Critique of methodology:


L, Singh V, Nonconsecutive patients
Falco FJ, Study design: RCT Nonrandomized
Cash KA, Type of Nonmasked reviewers
Pampati V. evidence Stated objective of study: To compare interlaminar epidural Nonmasked patients
Evaluation of therapeutic corticosteroid injection to interlaminar epidural local No validated outcome measures
the anesthetic injection used
effectiveness Small sample size
of lumbar Type of treatment(s): interlaminar epidural corticosteroid <80% follow-up
interlaminar injection, interlaminar epidural local anesthetic injection Lacked subgroup analysis
epidural Diagnostic method not stated
injections in Total number of patients: 120 Other: Repeat injections allowed-not
managing Number of patients in relevant subgroup(s): steroid: 60, local clear in subgroup analysis the extent of
chronic pain anesthetic: 60 repeat injections
of lumbar
disc Consecutively assigned? No
herniation or Work group conclusions
radiculitis: a Duration of follow-up: three, six and 12 months Potential Level: II
randomized, Downgraded Level: III
double-blind, Validated outcome measures used (list): Numeric Rating
controlled Scale (NRS), ODI Conclusions relative to question
trial. Pain This paper provides evidence
Physician. Nonvalidated outcome measures used (list): medication use that:interlaminar epidural steroid
Jul- injection provides better relief of pain
Aug;13(4):34 Diagnosis made by: and disability at six months than sham
3-355. Clinical exam/history (interlaminar epidural local anesthetic)
Electromyography in the treatment of patients with lumbar
Myelogram disc herniation with radiculopathy. This
MRI paper included many patients with
CT chronic and bilateral pain, and the work
CT/Myelogram group questioned the underlying
Other: diagnosis.

Results/subgroup analysis (relevant to question):


1) At three months and 12 months, both groups had
significant NRS and ODI improvement.
2) At six months the steroid group had significantly greater
NRS & ODI improvement than the local anesthetic group.
3) No significant difference in opioids but both groups
improved.

Author conclusions (relative to question): Both the local


anesthetic and steroid groups had significant long and short-
term improvement in VAS and ODI.

Schaufele Level IV Prospective Retrospective Critique of methodology:


MK, Hatch L, Nonconsecutive patients
Jones W. Study design: case control Nonrandomized
Interlaminar Type of Nonmasked reviewers
versus evidence Stated objective of study: Determine a difference in short- Nonmasked patients
transforamin therapeutic term pain improvement and long-term surgical rates between No validated outcome measures
al epidural interlaminar and transforaminal injection techniques. used
injections for Small sample size
the treatment Type of treatment(s): Interlaminar epidural steroid injection; <80% follow-up
of transforaminal epidural steroid injection Lacked subgroup analysis
symptomatic Diagnostic method not stated
lumbar Total number of patients: 40 Other: follow-up injections not
intervertebral Number of patients in relevant subgroup(s): interlaminar: 20, standardized
disc steroid: 20
herniations.
Pain Consecutively assigned? Yes Work group conclusions
Physician. Potential Level: III
Oct Duration of follow-up: Numeric Rating Scale(NRS): 18 days; Downgraded Level: IV
2006;9(4):36 surgery: one year
1-366. Conclusions relative to question
Validated outcome measures used (list): NRS This paper provides evidence
that:transforaminal epidural steroid
Nonvalidated outcome measures used (list): Surgery injection is more effective than
interlaminar epidural steroid injection for
Diagnosis made by: short term radicular pain relief, and is
Clinical exam/history associated with fewer surgical
Electromyography interventions for lumbar disc herniation.
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): There was


a statistically significant improvement in the NRS scores at
follow-up benefiting the transforaminal group. The average
NRS improvement was 46% in the transforaminal group and
19% in the interlaminar group. Surgery was performed in
25% of the interlaminar group and 10% of the transforaminal
group.

Author conclusions (relative to question): Transforaminal


epidural steroid injections for treatment of radicular pain due
to lumbar disc herniation resulted in better short-term pain
improvement and fewer long-term surgeries.

Vad VB, Level II Prospective Retrospective Critique of methodology:


Bhat AL, Nonconsecutive patients
Lutz GE, Study design: RCT Nonrandomized
Cammisa F. Type of Nonmasked reviewers
Transforamin evidence Stated objective of study: To compare transforaminal Nonmasked patients
al epidural therapeutic epidural steroid injection with saline trigger point injection No validated outcome measures
steroid used in the treatment of lumbosacral radiculopathy used
injections in secondary to herniated nucleus pulposus. Small sample size
lumbosacral <80% follow-up
radiculopathy Type of treatment(s): transforaminal epidural steroid Lacked subgroup analysis
:a injection/ paravertebral trigger point injection Diagnostic method not stated
prospective Other: randomization process unclear
randomized Total number of patients: 50
study. Spine Number of patients in relevant subgroup(s): transforaminal
(Phila Pa epidural steroid injection: 25, saline trigger point injection: 25 Work group conclusions
1976). Jan 1 Potential Level: II
2002;27(1):1 Consecutively assigned? Yes Downgraded Level:
1-16.
Duration of follow-up: 12 months Conclusions relative to question
This paper provides evidence that:
Validated outcome measures used (list): VAS; Roland- transforaminal epidural steroid injection
Morris is more effective in relieving radicular
pain and improving function than a
Nonvalidated outcome measures used (list): patient sham control of trigger point injections
satisfaction with normal saline in patients with
lumbar radiculopathy due to lumbar disc
Diagnosis made by: herniation.
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Successful


outcomes were defined as patient satisfaction scores of good
or very good, Roland Morris improvement of at least five and
VAS reduced by at least 50% at one year. The success rate
was significantly better in the transforaminal epidural steroid
group (84%) compared to the saline trigger point group
(48%).

Author conclusions (relative to question): The group


receiving the transforaminal epidural steroid injection had a
significantly better success rate at one year follow-up
compared to the group receiving the saline trigger point
injection for the treatment of lumbosacral radiculopathy.
Question #10:
What is the role of interventional spine procedures such as intradiscal electrothermal annuloplasty (IDEA or IDET) and
percutaneous discectomy (chemical or mechanical) in the treatment of lumbar disc herniation?

NOTE:
For the purpose of this guideline, the work group defined percutaneous discectomy as any discectomy procedure that
does not require open dissection of the thoracolumbar fascia. This includes endoscopic discectomy.

Article Level
(Alpha by of Description of study Conclusion
Author) evidence

Ahn Y, Lee Level IV Prospective Retrospective Critique of methodology:


SH, Lee JH, Nonconsecutive patients
Kim JU, Liu Study design: case series Nonrandomized
WC. Type of Nonmasked reviewers
Transforamin evidence Stated objective of study: To assess the clinical outcome, Nonmasked patients
al therapeutic prognostic factors and the technical pitfalls of percutaneous No validated outcome measures
percutaneou endoscopic lumbar discectomy for upper lumbar disc herniation. used
s endoscopic Small sample size
lumbar Type of treatment(s): percutaneous discectomy <80% follow-up
discectomy Lacked subgroup analysis
for upper Total number of patients: 45 Diagnostic method not stated
lumbar disc Number of patients in relevant subgroup(s): 45 Other:
herniation:
clinical Consecutively assigned? Yes
outcome, Work group conclusions
prognostic Duration of follow-up: 25-52 months with a mean of 38.8 Potential Level: IV
factors, and months Downgraded Level:
technical
consideration Validated outcome measures used (list): The intensity of the Conclusions relative to question
. Acta pain was measured using a visual analog scale (VAS, 010 This paper provides evidence that:
Neurochir points). transforaminal endoscopic
(Wien). Mar percutaneous discectomy can be
2009;151(3): Nonvalidated outcome measures used (list): The patients effective for treatment of upper lumbar
199-206. status was classified as excellent (Prolo scale score, 910), disc herniations at L1-2 and L2-3.
good (78), fair (56), and poor (4 or less)

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Based on the


Prolo scale, the outcomes were excellent in 21 of 45 patients
(46.7%), good in 14 patients (31.1%), fair in six patients
(13.3%), and poor in four patients (8.9%). The combined rate of
excellent or good outcome at the final follow-up was 77.8%. The
mean VAS for radicular pain was 8.38 1.22, and after
operation decreased to 2.36 1.65 (P < 0.0001).

Author conclusions (relative to question): Patient selection and


an anatomically modified surgical technique are important
factors in a successful outcome after transforaminal
percutaneous endoscopic operation for upper lumbar disc
herniation.

Ahn Y, Lee Level IV Prospective Retrospective Critique of methodology:


SH, Park Nonconsecutive patients
WM, Lee HY, Study design: case series Nonrandomized
Shin SW, Type of Nonmasked reviewers
Kang HY. evidence Stated objective of study: To evaluate the efficacy of Nonmasked patients
Percutaneou therapeutic endoscopic discectomy for recurrent disc herniations and to No validated outcome measures
s endoscopic determine the prognostic factors affecting surgical outcome. used
lumbar Small sample size
discectomy Type of treatment(s): percutaneous endoscopic lumbar <80% follow-up
for recurrent discectomy Lacked subgroup analysis
disc Diagnostic method not stated
herniation: Total number of patients: 43 Other:
surgical Number of patients in relevant subgroup(s): 43
technique,
outcome, Consecutively assigned? Yes Work group conclusions
and Potential Level: IV
prognostic Duration of follow-up: The mean follow-up period was 31 Downgraded Level:
factors of 43 months (2439 months).
consecutive Conclusions relative to question
cases. Spine Validated outcome measures used (list): Visual analog scales This paper provides evidence that:
(Phila Pa (VAS). percutaneous endoscopic lumbar
1976). Aug discectomy is effective for recurrent
15 Nonvalidated outcome measures used (list): The surgical disc herniation in selected cases.
2004;29(16): outcomes were assessed using the MacNab criteria
E326-332. The work group debated the eligibility
Diagnosis made by: of this paper for inclusion in the
Clinical exam/history guideline. Several members opposed
Electromyography its inclusion because the paper
Myelogram evaluated the treatment of recurrent
MRI herniations. Proponents pointed out
CT that patients included in the study had
CT/Myelogram a mean pain-free interval after their
Other: previous surgery of 63 months, ranging
from six to 186 months. Furthermore,
the question serving as the basis for
Results/subgroup analysis (relevant to question): Based on the the literature review and guideline
MacNab criteria, the surgical outcomes were rated as follows: formulation did not specifically exclude
excellent in 12 patients (27.9%), good in 23 (53.5%), fair in six recurrent herniation (although all
(13.9%), and poor in two (4.7%). Therefore, the percentage of committee members inferred that the
successful out- comes was 81.4%, whereas the rate of guideline development was intended to
improvement was 95.3%. The preoperative mean VAS was address virgin disc herniations).
8.72 +/- 1.20, which decreased to 2.58 +/- 1.55 at the final
follow-up (P<0.0001).

Author conclusions (relative to question): Percutaneous


endoscopic lumbar discectomy is effective for recurrent disc
herniation in selected cases.
Alo KM, Level IV Prospective Retrospective Critique of methodology:
Wright RE, Nonconsecutive patients
Sutcliffe J, et Study design: case series Nonrandomized
al. Type of Nonmasked reviewers
Percutaneou evidence Stated objective of study: To report outcomes of 50 patients Nonmasked patients
s lumbar therapeutic treated with the Dekompressor 1.5mm percutaneous lumbar No validated outcome measures
discectomy: discectomy probe at a six month follow-up. used
clinical Small sample size
response in Type of treatment(s): percutaneous lumbar discectomy <80% follow-up
an initial Lacked subgroup analysis
cohort of fifty Total number of patients: 50 Diagnostic method not stated
consecutive Number of patients in relevant subgroup(s): 50 Other:
patients with
chronic Consecutively assigned? Yes
radicular Work group conclusions
pain. Pain Duration of follow-up: six months Potential Level: IV
Prac Downgraded Level:
2004;4(1):19 Validated outcome measures used (list): VAS
-29. Conclusions relative to question
Nonvalidated outcome measures used (list): analgesic This paper provides evidence
consumption, self-reported functional improvement, overall that:Satisfactory outcomes can be
satisfaction achieved in patients with radicular pain
associated with disc herniations that
Diagnosis made by: are less than 6 mm in size and are
Clinical exam/history treated with the Dekompressor
Electromyography 1.5mm percutaneous lumbar
Myelogram discectomy probe.
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Percutaneous


discectomy was completed in 50 patients (62 levels) with an
average reduction in preoperative pain score (VAS) of 60.25%
(P < 0.001). Of the patients included in the study, 74% reported
reducing their analgesic intake, 90% reported improvement in
post-decompression functional status, and overall satisfaction
with therapy was greater than 80%. There were no procedure
related complications.

Author conclusions (relative to question): This preliminary


cohort obtained safe and efficacious disc removal and pain
relief without complication at six months. Percutaneous
discectomy can be successfully integrated into a conservative
treatment algorithm for chronic discogenic leg pain patients.

Cervellini P, Level IV Prospective Retrospective Critique of methodology:


De Luca GP, Nonconsecutive patients
Mazzetto M, Study design: case series Nonrandomized
Colombo F. Type of Nonmasked reviewers
Micro- evidence Stated objective of study: To describe the author's experience Nonmasked patients
endoscopic- therapeutic in the treatment of extraforaminal disc herniation via the No validated outcome measures
discectomy microendoscopic far lateral approach used
(MED) for far Small sample size
lateral disc Type of treatment(s): microendoscopic far lateral approach <80% follow-up
herniation in Lacked subgroup analysis
the lumbar Total number of patients: 17 Diagnostic method not stated
spine. Number of patients in relevant subgroup(s): 17 Other: consecutive patients?; review
Technical process not described
note. Acta Consecutively assigned?
Neurochir
Suppl. Duration of follow-up: 1-4 years Work group conclusions
2005;92:99- Potential Level: IV
101. Validated outcome measures used (list): Downgraded Level:

Nonvalidated outcome measures used (list): MacNab criteria Conclusions relative to question
This paper provides evidence that:The
Diagnosis made by: minimally invasive surgical treatment
Clinical exam/history via the microendoscopic far lateral
Electromyography approach, is a viable treatment
Myelogram alternative for far lateral disc
MRI herniations.
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): All patients


had excellent or good outcomes.

Author conclusions (relative to question): The minimally


invasive surgical treatment via the microendoscopic far lateral
approach, in our initial experience, has a high rate of success

Cohen SP, Level IV Prospective Retrospective Critique of methodology:


Williams S, Nonconsecutive patients
Kurihara C, Study design: case series Nonrandomized
Griffith S, Type of Nonmasked reviewers
Larkin TM. evidence Stated objective of study: To determine the treatment outcomes Nonmasked patients
Nucleoplasty therapeutic of 16 consecutive patients with lumbar radicular pain secondary No validated outcome measures
with or to a herniated disc who underwent nucleoplasty as their primary used
without therapy. Small sample size
intradiscal <80% follow-up
electrotherm Type of treatment(s): Nucleoplasty, intradiscal electrothermal Lacked subgroup analysis
al therapy therapy (IDET) Diagnostic method not stated
(IDET) as a Other:
treatment for Total number of patients: 16
lumbar Number of patients in relevant subgroup(s): 7
herniated Work group conclusions
disc. J Spinal Consecutively assigned? Yes Potential Level: IV
Disord Tech. Downgraded Level:
Feb 2005;18 Duration of follow-up: 8.6 months
Suppl:S119- Conclusions relative to question
124. Validated outcome measures used (list): The primary indicator This paper provides evidence
of success was a greater than, or equal to, 50% reduction in that:nucleoplasty was not an effective
pain at the latest follow-up visit. treatment option in this small
retrospectively reviewed cohort of
Nonvalidated outcome measures used (list): Three secondary patients.
measures included: reduction in opioid usage, retention on
active duty, and response to the question: Given the known
outcome, would you repeat the procedure?

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: discography

Results/subgroup analysis (relevant to question): Only one of


the seven patients in the relevant subgroup reported a greater
than, or equal to, 50% reduction in pain, which was the primary
outcome measure of success. That patient underwent a two
level nucleoplasty procedure.

Author conclusions (relative to question): The authors


concluded that given their selection criteria, nucleoplasty was
not an effective long term treatment for lumbar radiculopathy.

Davis GW, Level IV Prospective Retrospective Critique of methodology:


Onik G, Nonconsecutive patients
Helms C. Study design: case series Nonrandomized
Automated Type of Nonmasked reviewers
percutaneou evidence Stated objective of study: To report on the outcomes of 518 Nonmasked patients
s therapeutic consecutive patients treated for disc related sciatica with No validated outcome measures
discectomy. automated percutaneous discectomy (APD). used
Spine Small sample size
1991;16(3):3 Type of treatment(s): APD <80% follow-up
59-363 Lacked subgroup analysis
Total number of patients: 518 Diagnostic method not stated
Number of patients in relevant subgroup(s): 518 Other:

Consecutively assigned? Yes


Work group conclusions
Duration of follow-up: two years Potential Level: IV
Downgraded Level:
Validated outcome measures used (list):
Conclusions relative to question
Nonvalidated outcome measures used (list): Successful This paper provides evidence that:
outcome: moderate to complete pain relief, no narcotic percutaneous discectomy can be used
medication, return to preinjury functional status, and patient effectively in patients with sciatica
satisfaction with the procedure. caused by small, contained disc
herniations.
Diagnosis made by:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): 85% overall


success rate: 87% success in noncompensation patients; 74%
in compensation patients

Author conclusions (relative to question): APD should play a


valuable role in the treatment of primary and recurrent disc
herniation.

Faubert C, Level IV Prospective Retrospective Critique of methodology:


Caspar W. Nonconsecutive patients
Lumbar Study design: case series Nonrandomized
percutaneou Type of Nonmasked reviewers
s evidence Stated objective of study: To present the short-term follow-up Nonmasked patients
discectomy. therapeutic analysis of 28 patients who underwent a percutaneous No validated outcome measures
Initial discectomy at L4-5 after presenting with an L5 radiculopathy used
experience in that was refractory to conservative therapy. Small sample size
28 cases. <80% follow-up
Neuroradiolo Type of treatment(s): percutaneous lumbar discectomy Lacked subgroup analysis
gy. Diagnostic method not stated
1991;33(5):4 Total number of patients: 28 Other:
07-410. Number of patients in relevant subgroup(s): 28

Consecutively assigned? No Work group conclusions


Potential Level: IV
Duration of follow-up: at least two months. Downgraded Level:

Validated outcome measures used (list): Conclusions relative to question


This paper provides evidence
Nonvalidated outcome measures used (list): Subjective that:percutaneous lumbar discectomy
is a viable treatment alternative for
Diagnosis made by: patients presenting with an L5
Clinical exam/history radiculopathy from an L4-5 disc
Electromyography herniation that is refractory to
Myelogram conservative treatment. The lack of
MRI validated outcome measures
CT decreased the value of this
CT/Myelogram retrospective case series.
Other:

Results/subgroup analysis (relevant to question): 18 of 28


patients (64.3%) were considered to have good or fair
outcomes. Ten of 28 (35.7%) patients had no leg or back pain
relief, experienced a worsening condition, and were unable to
resume work or other activities. Nine of 28 (32.1%) were later
treated with open surgery. There were no major operative
complications. Four patients (14.3%) were considered to have
had poor indications for percutaneous discectomy because of
concomitant spinal stenosis, the presence of a "lateralized
foraminal herniation," or because the predominant symptom
was back pain.

Author conclusions (relative to question): Percutaneous


discectomy is a viable alternative to open surgery as a first step
procedure when performed in experienced hands.

Gallucci M, Level I Prospective Retrospective Critique of methodology:


Limbucci N, Nonconsecutive patients
Zugaro L, et Study design: RCT Nonrandomized
al. Sciatica: Type of Nonmasked reviewers
Treatment evidence Stated objective of study: To prospectively compare the clinical Nonmasked patients
with therapeutic effectiveness of intraforaminal and intradiscal injections of a No validated outcome measures
intradiscal mixture of a steroid, a local anesthetic and oxygen-ozone (O2- used
and O3) to intraforaminal and intradiscal injections of a steroid and Small sample size
intraforamina an anesthetic in the management of radicular pain related to <80% follow-up
l injections of acute lumbar disc herniation. Lacked subgroup analysis
steroid and Diagnostic method not stated
oxygen- Other: 12% of treatment group had
ozone versus Type of treatment(s): Group A, the control group, underwent two injections
steroid only. intraforaminal and intradiscal injections of 2 mL of triamcinolone
Radiology. acetonide (40 mg/mL Kenacort; Bristol-Myers Squibb,
2007;242(3): Sermoneta, Italy), with 1 mL injected in the epidural space and Work group conclusions
907-913. 1 mL injected inside the disc, and 24 mL of 2% ropivacaine Potential Level: I
(Naropina; AstraZeneca, Basiglio, Italy), about 2 mL injected in Downgraded Level:
the epidural space and 1 mL injected inside the disc. Group B,
the treatment group, received the same treatment with the Conclusions relative to question
addition of an O2-O3 mixture, with an ozone concentration of This paper provides evidence
28 mcg/mL. Intraforaminal and intradiscal injections of O2-O3 that:intraforaminal and intradiscal local
(57 mL; mean 6.5 & 5.8 mL, respectively) were injected in anesthetic, steroid and O2-O3
Group B. injections proved superior to
intraforaminal and intradiscal local
Total number of patients: 159 anesthetic and steroid injections alone
Number of patients in relevant subgroup(s): Group A (control) at six months in the treatment of
included 77 patients; Group B (treatment) included 82 patients. radicular pain caused by lumbar disc
herniation. Both groups achieved
Consecutively assigned? Yes success at two weeks and three
months.
Duration of follow-up: six months

Validated outcome measures used (list): ODI


Nonvalidated outcome measures used (list):

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question):


In Group A, the treatment was a success in 69 (90%) of 77
patients (95% confidence interval [CI]: 80.6%, 95.4%) after two
weeks, 52 (67%) patients (95% CI: 55.9%, 77.8%) after three
months, and 36 (47%) patients (95% CI: 35.3%, 58.5%) after
six months.

In group B, the treatment was a success in 72 (88%) of 82


patients (95% CI: 78.8%, 93.4%) after two weeks, 64 (78%)
patients (95% CI: 67.5%, 86.4%) after three months, and 61
(74%) patients (95% CI: 63.6%, 83.3%) after six months.

There was a statistically significant difference (P<.01) in the


success rate in favor of Group B - the group treated with O2-O3
injections.

Author conclusions (relative to question): O2-O3


chemodiscolysis should be regarded as a useful treatment for
the management of lumbar disc herniation.

Gerszten Level III Prospective Retrospective Critique of methodology:


PC, Smuck Nonconsecutive patients
M, Rathmell Study design: RCT Nonrandomized
JP, et al. Type of Nonmasked reviewers
Plasma disc evidence Stated objective of study: To assess the utility of transforaminal Nonmasked patients
decompressi therapeutic epidural steroid injections (TFESI) versus plasma disc No validated outcome measures
on compared decompression (PDD) for patients with contained disc used
with herniations who had already failed TFESI. Small sample size
fluoroscopy- <80% follow-up
guided Type of treatment(s): TFESI, PDD Lacked subgroup analysis
transforamin Diagnostic method not stated
al epidural Total number of patients: 85 Other:
steroid Number of patients in relevant subgroup(s): PDD Group: 45
injections for patients, (29 patients at 6 months follow-up); TFESI Group: 40
symptomatic patients,(28 patients at 6 months follow-up). Work group conclusions
contained Potential Level: II
lumbar disc Consecutively assigned? Yes Downgraded Level: III
herniation: a
prospective, Duration of follow-up: six months Conclusions relative to question
randomized, This paper provides evidence that:
controlled Validated outcome measures used (list): VAS (primary Level III evidence that patients with
trial. J outcome), SF-36, ODI radicular pain associated with a lumbar
Neurosurg disc herniation had significantly
Spine. Nonvalidated outcome measures used (list): analgesic use, greater reductions in back and leg pain
Apr;12(4):35 employment status, patient satisfaction and improved quality of life scores
7-371. following treatment with plasma disc
Diagnosis made by: decompression compared to a
Clinical exam/history repeated course of failed
Electromyography transforaminal epidural steroid
Myelogram injection.
MRI
CT Level IV evidence that select patients
CT/Myelogram with contained disc herniations, not
Other: responsive to a transforaminal epidural
steroid injection, may experience
significant reductions in radicular pain
Results/subgroup analysis (relevant to question): At six and improved quality of life scores at
months, leg pain VAS scores were significantly reduced from six months following lumbar plasma
baseline in both treatment groups. Back pain VAS and ODI disc decompression.
scores were significantly reduced from baseline in the PDD
group, while these scores for the TFESI group were not. Leg
and back pain VAS scores, and ODI scores differed significantly
between the two groups favoring the PDD group. The PDD
group had significantly greater improvement in SF-36 physical
function, bodily pain, social function and physical components
summary scores compared to the TFESI group. A significantly
greater percentage of patients in the PDD group were satisfied
with care. The number of patients working full or part-time (69-
70%) was similar for both groups. Reduction in the use of
analgesics did not differ between the groups.

Author conclusions (relative to question): this study shows that


patients with radicular pain associated with a contained lumbar
disc herniation and treated with PDD following a failed TFESI
receive clinically significant benefits over a repeated course of
TFESI.

Haines SJ, Level III Prospective Retrospective Critique of methodology:


Jordan N, Nonconsecutive patients
Boen JR, Study design: RCT Nonrandomized
Nyman JA, Type of Nonmasked reviewers
Oldridge NB, evidence Stated objective of study: To estimate the success rates of Nonmasked patients
Lindgren BR. therapeutic automated or endoscopic percutaneous discectomy and No validated outcome measures
Discectomy conventional discectomy in comparable patients and to used
strategies for document the resource consumption of patients treated in these Small sample size
lumbar disc ways. <80% follow-up
herniation: Lacked subgroup analysis
results of the Type of treatment(s): automated percutaneous discectomy; Diagnostic method not stated
LAPDOG conventional discectomy Other: litigation status of subjects;
trial. J Clin changed procedures mid-study from
Neurosci. Jul Total number of patients: 34 automated percutaneous discectomy to
2002;9(4):41 Number of patients in relevant subgroup(s): automated endoscopic discectomy with no
1-417. percutaneous discectomy / endoscopic percutaneous subgroup analysis
discectomy - 21; conventional discectomy - 13

Consecutively assigned? Yes Work group conclusions


Potential Level: II
Duration of follow-up: six months Downgraded Level: III
Validated outcome measures used (list): modified Roland Conclusions relative to question
Scale; SF-36. This paper provides evidence
that:patients treated with automated or
Nonvalidated outcome measures used (list): A four dimension endoscopic discectomy and
outcome assessment matrix developed by the authors that conventional discectomy have
incorporated patient assessment of pain frequency and severity, comparable outcomes at six months.
ability to participate in activities of work and leisure and
analgesic use, factors commonly used in published studies of This potentially Level II study was
treatment for herniated lumbar disc. downgraded to Level III because of the
small sample size of the two groups
Diagnosis made by: (enrollment was projected to include
Clinical exam/history 330 patients). There was also disparity
Electromyography between the number of patients
Myelogram involved in litigation between the two
MRI groups.
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): There was no


statistical difference between the two groups for the primary and
secondary outcome measures. The success rate for the
primary outcome measure was 41% in the automated
percutaneous discectomy group and 40% in the conventional
discectomy group. Both groups showed significant
improvement in the secondary outcome measures at six
months.

Author conclusions (relative to question): The authors


concluded that their trial did not enroll sufficient numbers of
patients to reach a definitive conclusion about the efficacy and
cost-effectiveness of standard and automated or endoscopic
percutaneous discectomy in the treatment of radiculopathy
related to lumbar disc herniation.
Hermantin Level II Prospective Retrospective Critique of methodology:
FU, Peters T, Nonconsecutive patients
Quartararo L, Study design: comparative Nonrandomized
Kambin P. A Type of Nonmasked reviewers
prospective, evidence Stated objective of study: Evaluate the results of arthroscopic Nonmasked patients
randomized therapeutic percutaneous lumbar discectomy compared with open No validated outcome measures
study discectomy in patients with lumbar disc herniation and used
comparing radiculopathy. Small sample size
the results of <80% follow-up
open Type of treatment(s): video-assisted endoscopic Lacked subgroup analysis
discectomy microdiscectomy, open discectomy Diagnostic method not stated
with those of Other: randomization limited to
video- Total number of patients: 60 patients not sent for one procedure or
assisted Number of patients in relevant subgroup(s): another and only performed in select
arthroscopic 30 endoscopic discectomy; 30 open discectomy patients who agreed to randomization
microdiscect and who met inclusion criteria for
omy. J Bone Consecutively assigned? No endoscopic percutaneous lumbar
Joint Surg discectomy.
Am. Jul Duration of follow-up: Open discectomy: 31 months (19-42
1999;81(7):9 months); endoscopic discectomy: 32 months ( 21- 42 months).
58-965. Work group conclusions
Validated outcome measures used (list): Pain intensity Scale Potential Level: II
(0-10) Downgraded Level:

Nonvalidated outcome measures used (list): Conclusions relative to question


(1) Satisfactory outcome based on excellent or good results This paper provides evidence
related to the following: patient's perioperative self-evaluation, that:compared to open discectomy,
return to normal activity, findings on physical exam, and patient select patients with lumbar disc
satisfaction. (2) Four point patient satisfaction scale. herniation and radiculopathy treated
with endoscopic discectomy
Diagnosis made by: postoperatively consume less opioids
Clinical exam/history and resume normal activity levels
Electromyography sooner.
Myelogram
MRI
CT
CT/Myelogram
Other: imaging

Results/subgroup analysis (relevant to question): The mean


postoperative pain score was 1.9 and 1.2 in the open
discectomy and endoscopic discectomy groups, respectively.
There was no difference in satisfactory outcomes between the
groups: 93% satisfactory outcome in open discectomy, 97% in
endoscopic. A very satisfactory outcome was reported in 67%
and 73% of the open discectomy and endoscopic discectomy
groups, respectively. Narcotic use was longer (25 days vs
seven days) in patients treated with open discectomy. Average
postoperative disability was 49 and 27 days in the open
discectomy and endoscopic discectomy groups, respectively.

Author conclusions (relative to question): In carefully selected


patients, endoscopic percutaneous lumbar discectomy is a
useful treatment for lumbar disc herniation.

Jang JS, An Level IV Prospective Retrospective Critique of methodology:


SH, Lee SH. Nonconsecutive patients
Transforamin Study design: case series Nonrandomized
al Type of Nonmasked reviewers
percutaneou evidence Stated objective of study: To document the outcome for 35 Nonmasked patients
s endoscopic therapeutic patients with intraforaminal and extraforaminal herniated discs No validated outcome measures
discectomy who were surgically treated with transforaminal percutaneous used
in the endoscopic lumbar discectomies. Small sample size
treatment of <80% follow-up
foraminal Type of treatment(s): transforaminal percutaneous endoscopic Lacked subgroup analysis
and lumbar discectomy Diagnostic method not stated
extraforamin Other: Follow-up not standardized
al lumbar Total number of patients: 35
disc Number of patients in relevant subgroup(s): 35
herniations. J Work group conclusions
Spinal Disord Consecutively assigned? Yes Potential Level: IV
Tech. Jul Downgraded Level:
2006;19(5):3 Duration of follow-up: 18 months (10-35 months)
38-343. Conclusions relative to question
Validated outcome measures used (list): VAS This paper provides evidence that:the
posterolateral endoscopic approach to
Nonvalidated outcome measures used (list): MacNab criteria foraminal and extraforaminal lumbar
disc herniations for the decompression
Diagnosis made by: of the exiting root constitutes a
Clinical exam/history minimally invasive procedure that
Electromyography seems to be effective in the majority of
Myelogram patients. However, 17% of patients
MRI experienced postoperative
CT dysesthesias in the distribution of the
CT/Myelogram affected nerve root and 8.6% of
Other: patients eventually had open surgery
for persistent radiculopathy.

Results/subgroup analysis (relevant to question): In the


immediate postoperative period, six patients (17%) developed
burning dysesthesia in the sensory distribution of the operated
nerve root. The mean preoperative and postoperative VAS
scores went from 8.6 before the surgery to 3.2 after the surgery.
These improvements were statistically significant (P<0.01).
Overall, excellent or good outcomes were obtained in 30
(85.7%) of the 35 patients as determined at the last follow-up
examination according to the MacNab criteria.

Author conclusions (relative to question): In our limited


experience, the posterolateral endoscopic approach to
foraminal and extraforaminal lumbar disc herniations for the
decompression of the exiting root contributes a minimally
invasive procedure that seems to be safe and effective.

Kanai A. Level IV Prospective Retrospective Critique of methodology:


Treatment of Nonconsecutive patients
lumbar disk Study design: case series Nonrandomized
herniation by Type of Nonmasked reviewers
percutaneou evidence Stated objective of study: Evaluate the efficacy of a modification Nonmasked patients
s intradiscal therapeutic of minimally invasive percutaneous intradiscal high-pressure No validated outcome measures
high- injection with saline (IDHP) on persistent pain and disability used
pressure caused by lumbar disc herniation refractory to conservative Small sample size
injection of care. <80% follow-up
saline. Pain Lacked subgroup analysis
Medicine. Type of treatment(s): Intradiscal high-pressure injection with Diagnostic method not stated
2009;10(1):7 saline Other:
6-84.
Total number of patients: 25
Number of patients in relevant subgroup(s): annular tear group: Work group conclusions
20; nontear group: 5. Potential Level: IV
Downgraded Level:
Consecutively assigned? Yes
Conclusions relative to question
Duration of follow-up: Clinical: six months; MRI: 3-6 months This paper provides evidence
that:Intradiscal high-pressure injection
Validated outcome measures used (list): Visual Analog Scale with saline for the treatment of lumbar
(VAS), MRI radiculopathy due to extruded and
sequestered discs reliably provides
Nonvalidated outcome measures used (list): Japanese significant pain relief and recovery at
Orthopaedic Association (JOA) Score six months follow-up.

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Tear group


disc morphology included 100% of the extruded and
sequestered discs and 44% of the protruded discs. The tear
group had significantly improved VAS and JOA scores at six
months compared to the nontear group. The tear group had
disappearance of all lumbar disc herniations on follow-up MRI.

The nontear group had 56% of the protruded lumbar disc


herniations, and no extrusions or sequestrations. The nontear
group had a one month improvement in VAS and JOA scores.
There were slight changes in lumbar disc herniation morphology
on follow-up MRI between preprocedure and postprocedure
images in the nontear group.

There were no complications reported in either group.

Author conclusions (relative to question): Intradiscal high-


pressure injection of saline is associated with good outcomes in
patients with lumbar radiculopathy due to lumbar disc
herniation. The treatment is more effective in patients with
extrusions and sequestrations.

Lierz P, Alo Level IV Prospective Retrospective Critique of methodology:


KM, Felleiter Nonconsecutive patients
P. Study design: case series Nonrandomized
Percutaneou Type of Nonmasked reviewers
s lumbar evidence Stated objective of study: To assess the utility of using the Nonmasked patients
discectomy therapeutic Dekompressor system under CT-control in an attempt to No validated outcome measures
using the improve postinterventional results and minimize the rate of used
Dekompress complications Small sample size
or system <80% follow-up
under CT- Type of treatment(s): Automated percutaneous lumbar Lacked subgroup analysis
control. Pain discectomy (Dekompressor) Diagnostic method not stated
Pract. May- Other:
Jun Total number of patients: 64
2009;9(3):21 Number of patients in relevant subgroup(s):
6-220. Work group conclusions
Consecutively assigned? No Potential Level: IV
Downgraded Level:
Duration of follow-up: one year
Conclusions relative to question
Validated outcome measures used (list): Visual Analog Scale This paper provides evidence that:with
standardized selection criteria, single
Nonvalidated outcome measures used (list): Opioid use, level automated percutaneous lumbar
Activities of daily living, patient satisfaction discectomy is associated with rapid
and sustained satisfactory relief from
Diagnosis made by: radicular pain due to a contained
Clinical exam/history lumbar disc herniation of 6 mm or less.
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: Diagnostic selective nerve root block; Imaging ("eg.
MRI")

Results/subgroup analysis (relevant to question): The average


pain score was significantly improved at two days, and six and
12 months post-procedure. Reduction in analgesic use and
improvement in activities of daily living were seen in 80% and
77%, respectively, at 12 months. Patient satisfaction was
reported for 77% at 12 months. There was a significant
favorable difference in patient satisfaction, analgesic use, and
activities of daily living in patients treated at a single level.

Author conclusions (relative to question): When standardized


patient selection criteria are used, treatment of patients with
radicular pain associated with contained disc herniation using
Dekompressor can be a safe and efficient procedure.

Mayer HM, Level III Prospective Retrospective Critique of methodology:


Brock M. Nonconsecutive patients
Percutaneou Study design: RCT Nonrandomized
s endoscopic Type of Nonmasked reviewers
discectomy: evidence Stated objective of study: Present the results of a prospective Nonmasked patients
surgical therapeutic randomized study on two series of patients with comparable No validated outcome measures
technique indication criteria treated at our institution by either used
and percutaneous endoscopic discectomy or microdiscectomy. Small sample size
preliminary <80% follow-up
results Type of treatment(s): percutaneous endoscopic discectomy Lacked subgroup analysis
compared to (PED) and microdiscectomy (MD) were used to treat patients Diagnostic method not stated
microsurgical with lumbar radicular symptoms due to contained or small Other: randomization not described
discectomy. noncontained disc herniation.
J Neurosurg.
Feb Total number of patients: 40 Work group conclusions
1993;78(2):2 Number of patients in relevant subgroup(s): PED group, 20 Potential Level: II
16-225. patients; MD group, 20 patients Downgraded Level: III

Consecutively assigned? No Conclusions relative to question


This paper provides evidence
Duration of follow-up: two years that:percutaneous endoscopic
discectomy and microdiscectomy
Validated outcome measures used (list): provide statistically significant clinical
improvement from lumbar radicular
Nonvalidated outcome measures used (list): clinical scoring symptoms due to contained or small
system; patient's subjective evaluation; postoperative disability noncontained lumbar disc herniation at
two years. At two year follow-up patient
Diagnosis made by: satisfaction is greater in the
Clinical exam/history percutaneous endoscopic discectomy
Electromyography group, and average postoperative
Myelogram disability was markedly less in the
MRI percutaneous endoscopic discectomy
CT group compared to the
CT/Myelogram microdiscectomy group.
Other: discography, post-discography CT

Results/subgroup analysis (relevant to question): At two years


both the PED and MD group had statistically significant
improvement over their baseline clinical outcome score. The
patient's subjective evaluation of treatment was more favorable
in the PED group. Average postoperative disability was 7.7
weeks in the PED group and 22.9 weeks in the MD group.
19/20 patients in the PED group and 13/20 patients in the MD
group returned to their previous occupation.
Author conclusions (relative to question): PED can be a
surgical alternative for patients with contained or small
subligamentous lumbar disc herniations.

Revel M, Level III Prospective Retrospective Critique of methodology:


Payan C, Nonconsecutive patients
Vallee C, Study design: RCT Nonrandomized
Laredo JD, Type of Nonmasked reviewers
Lassale B, evidence Stated objective of study: To compare results of automated Nonmasked patients
Roux C, therapeutic percutaneous discectomy (APD) with those of No validated outcome measures
Carter H, chemonucleolysis. used
Salomon C, Small sample size
Delmas E, Type of treatment(s): automated percutaneous discectomy, <80% follow-up
Roucoules J. chemonucleolysis Lacked subgroup analysis
Automated Diagnostic method not stated
percutaneou Total number of patients: Of the 165 patients who were initially Other:
s randomized, 19 were excluded before treatment. Of the 141
lumbar treated patients, five were excluded after the first follow-up. This
discectomy left 69 patients in the automated percutaneous discectomy Work group conclusions
versus group and 72 in the chemonucleolysis group. Potential Level: II
chemonucleo Number of patients in relevant subgroup(s): Downgraded Level: III
lysis in the 69 automated percutaneous discectomy
treatment of Conclusions relative to question
sciatica. A Consecutively assigned? No This paper provides evidence
randomized that:automated percutaneous
multicenter Duration of follow-up: one, three, six, and 12 months discectomy can be expected to yield
trial. favorable outcomes in 44% of patients
Spine 1993; Validated outcome measures used (list): Visual Analog Scales, at six months.
18:1-7. Waddell Main functional outcome

Nonvalidated outcome measures used (list): MacNab Criteria


(investigators' opinion); patient self-assessment of treatment
outcome (none, moderate, good, very good) - a successful
outcome occurred if the patient considered their improvement
better than moderate.
Diagnosis made by:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Among the


patients who underwent the technical aspect of the procedure,
APD was deemed unsatisfactory in 10% of the patients.
Twenty-five of the patients withdrew from follow-up and were
considered failures. The overall assessment at six months for
those who completed the study was better in 83% and 68% of
the investigators and patients, respectively. Treatment with APD
was considered a success by 44% of the patients at six months.
At 12 months the overall success rate was 37%, and 61%
among those followed for one year.

Author conclusions (relative to question): there is no


methodologic nuance that can explain away the disappointing
results with APD.

Ruetten S, Level II Prospective Retrospective Critique of methodology:


Komp M, Nonconsecutive patients
Merk H, Study design: RCT Nonrandomized
Godolias G. Type of Nonmasked reviewers
Full- evidence Stated objective of study: comparison of results of lumbar Nonmasked patients
endoscopic therapeutic discectomies in full-endoscopic(FE) interlaminar(IL) and No validated outcome measures
interlaminar transforaminal(TF) technique with conventional microsurgical used
and technique(MI). Small sample size
transforamin <80% follow-up
al lumbar Type of treatment(s): Full-endoscopic interlaminar(FEIL) and Lacked subgroup analysis
discectomy full-endoscopic transforaminal(FETF) techniques; Microsurgical Diagnostic method not stated
versus technique(MI). Other: Full endoscopic approach
conventional blends data on two different technical
microsurgical Total number of patients: 200 approaches (38 transforaminal and 53
technique: a Number of patients in relevant subgroup(s): FEIL 59, FETF 41; interlaminar) without subgroup
prospective, MI 100 analysis. Diagnostic radiology studies
randomized, not described
controlled Consecutively assigned?
study. Spine
(Phila Pa Duration of follow-up: 24 months(178 patients: MI 87; FE 91) Work group conclusions
1976). Apr Potential Level: I
20 Validated outcome measures used (list): VAS leg and back; Downgraded Level: II
2008;33(9):9 NASS (German Version); ODI
31-939. Conclusions relative to question
Nonvalidated outcome measures used (list): a second surgical This paper provides evidence that:full-
procedure; postoperative pain and pain medication; endoscopic interlaminar and
postoperative work disability. transforaminal techniques provide
statistically equivalent improvements in
Diagnosis made by: pain and function over two years
Clinical exam/history compared to conventional
Electromyography microdiscectomy in patients with
Myelogram radicular pain due to lumbar disc
MRI herniation. Compared with
CT conventional microdiscectomy, full-
CT/Myelogram endoscopic discectomy is associated
Other: The indication for surgery was defined according to with significantly less postoperative
present-day standards based on radicular pain symptoms and work disability and use of pain
existing neurologic deficits. medication.

Results/subgroup analysis (relevant to question): There was


constant and significant improvement in leg pain and daily
activities in all groups. There was no significant differences in
results between the groups. 17/184 patients underwent a
second surgical procedure: MI 10 and FE 7 patients
respectively. Postoperative pain and pain medication were
significantly reduced in the FE-group. The mean postoperative
work disability was significantly less in the FE-group, 25 days in
the FE-group versus 49 days in the MI-group.
Author conclusions (relative to question): The clinical results of
the full endoscopic technique are equal to those of the
microsurgical technique.

Schaufele Level IV Prospective Retrospective Critique of methodology:


MK. Single Nonconsecutive patients
level lumbar Study design: case series Nonrandomized
disc Type of Nonmasked reviewers
herniations evidence Stated objective of study: Determine the effect and magnetic Nonmasked patients
resulting in therapeutic resonance imaging changes of targeted disc decompression No validated outcome measures
radicular using an intradiscal catheter for focal heating of symptomatic used
pain: pain lumbar disc herniation resulting in radicular pain. Small sample size
and <80% follow-up
functional Type of treatment(s): Percutaneous electrothermal disc Lacked subgroup analysis
outcomes decompression. Diagnostic method not stated
after Other:
treatment Total number of patients: 22
with targeted Number of patients in relevant subgroup(s): 16 patients
disc available for 12 months follow-up Work group conclusions
decompressi Potential Level: IV
on. Pain Consecutively assigned? No Downgraded Level:
Med. Oct
2008;9(7):83 Duration of follow-up: Clinical: three, six, and 12 months. Conclusions relative to question
5-843. Disc morphology: three months This paper provides evidence that:the
effect size for improvement in pain and
Validated outcome measures used (list): Visual Analog Scale, function due to disc protrusions is small
SF-36, patient satisfaction with this form of treatment.

Nonvalidated outcome measures used (list): lumbar disc


herniation change after treatment

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Significant


improvements for back and leg pain scores was present at all
follow-up time points. The average Visual Analog Scale back
and leg pain improvement was 2.4 and 2.6, respectively. Effect
sizes for back and leg pain were 0.9 and 1.0, respectively.

Significant improvements for SF-36 bodily pain and physical


function domains were present at all follow-up time points. The
average improvement in SF-36 bodily pain and physical
function scores were 28.8 and 25.4, respectively. Effect sizes
for SF-36 bodily pain and physical function were 1.4 and 1.2,
respectively.

Magnetic resonance imaging follow-up on 15/22 patients at


three months showed an average improvement on
anterioposterior, transverse and cranio-caudad images of 1.6
mm, 2.6 mm and 2.5 mm, respectively.

Author conclusions (relative to question): Targeted disc


decompression provided moderate improvement in leg pain and
function in the majority of patients with chronic radicular pain.

van Alphen Level III Prospective Retrospective Critique of methodology:


HA, Nonconsecutive patients
Braakman R, Study design: RCT Nonrandomized
Berfelo MW, Type of Nonmasked reviewers
Broere G, evidence Stated objective of study: to compare chymopapain and surgery Nonmasked patients
Bezemer PD, therapeutic in the treatment of one level disc herniation that failed surgery No validated outcome measures
Kostense PJ. used
Chemonucle Type of treatment(s): microdiscectomy versus chymopapain Small sample size
olysis or <80% follow-up
discectomy? Total number of patients: 151 Lacked subgroup analysis
Results of a Number of patients in relevant subgroup(s): 78 discectomy and Diagnostic method not stated
randomized 73 chymopapain Other: No subgroup analysis related
multicentre to sequestered or extruded discs.
trial in Consecutively assigned? Yes
patients with
a herniated Duration of follow-up: one year Work group conclusions
lumbar Potential Level: II
intervertebral Validated outcome measures used (list): Downgraded Level: III
disc (a
preliminary Nonvalidated outcome measures used (list): subjective Conclusions relative to question
report). Acta outcomes scale from doctors and patients, reoperation This paper provides evidence that:
neurochirurgi microdiscectomy is associated with
ca. Diagnosis made by: better outcomes than chymopapain
Supplementu Clinical exam/history
m. 1988:35- Electromyography
38. Myelogram
http://www.m MRI
rw.interscien CT
ce.wiley.com CT/Myelogram
/cochrane/clc Other:
entral/articles
/442/CN-
00057442/fra Results/subgroup analysis (relevant to question): 25%
me.html. reoperation rate after chymopapain compared to 3% for
microdiscectomy. Better patient and doctor reported outcomes
following microdiscectomy (25% crossover from chymopapain
to surgery group within one year). After crossover the overall
success rate in an intent-to- treat analysis showed 73% success
with chymopapain and 78% with surgery

Author conclusions (relative to question): Chymopapain is an


option in patients for whom conservative treatment has failed.
Question #11:
What is the role of ancillary treatments such as bracing, electrical stimulation, acupuncture, and transcutaneous electrical stimulation
(TENS) in the treatment of lumbar disc herniation?

Article Level
(Alpha by of Description of study Conclusion
Author) evidence

Unlu Z, Tascl Level II Prospective Retrospective Critique of methodology:


S, Tarhan S, Nonconsecutive patients
Pabuscu Y, Study design: RCT Nonrandomized
Islak S. Type of Nonmasked reviewers
Comparison evidence Stated objective of study: To compare pain and functional Nonmasked patients
of 3 physical therapeutic outcomes of ultrasound, traction, and "low powered" laser No validated outcome measures used
therapy for patients with symptomatic acute (less than 3 months) Small sample size
modalities for lumbar disc herniation <80% follow-up
acute pain in Lacked subgroup analysis
lumbar disc Type of treatment(s): ultrasound, low powered laser, Diagnostic method not stated
herniation intermittent traction Other: randomization method not stated
measured by
clinical Total number of patients: 60
evaluation Number of patients in relevant subgroup(s): 20 in each Work group conclusions
and group Potential Level: II
magnetic Downgraded Level: II
resonance Consecutively assigned? Yes
imaging. Conclusions relative to question
Journal of Duration of follow-up: three months This paper provides evidence that:
Manipulative Level II evidence comparing multiple
and Validated outcome measures used (list): VAS for back treatments; Level IV evidence for individual
Physiological and leg pain, "modified" Oswestry Disability, Roland treatment efficacy.
Therapeutics Disability questionnaire (RDQ)
. Mar-Apr Patients with symptomatic acute lumbar disc
2008;31(3):1 Nonvalidated outcome measures used (list): MRI disc herniations will improve when treated with
91-198. size, physical exam changes ultrasound, low powered laser or intermittent
traction. Since the study did not include an
Diagnosis made by: untreated control group, the possibility of
Clinical exam/history spontaneous improvement in this group of
Electromyography patients cannot be excluded.
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): All


groups had significant improvement in pain and disability
scores at all time periods and at the end of the study
period (three months). All had MRI evidence of
decreased disc herniation size. There were no differences
between the groups

Author conclusions (relative to question): The authors


concluded all three treatments (low powered laser,
traction, and ultrasound) were effective in the
management of this group of patients with acute lumbar
disc herniation.
Question #12:
a. What is the likelihood that a patient with lumbar disc herniation with radiculopathy undergoing
medical/interventional treatment would have good/excellent functional outcomes at short (weeks to six months),
medium (six months - two years) and long-term (greater than two years)?

Article Level
(Alpha by of Description of study Conclusion
Author) evidence

Lutz GE, Vad Level II Prospective Retrospective Critique of methodology


VB, Wisneski Patients not enrolled at same point in
RJ. Type of Study Design: cohort their disease
Fluoroscopic evidence <80% follow-up
transforamin prognostic Stated objective of study: Determine the therapeutic value and Follow-up not standardized
al lumbar long term effects of fluoroscopic transforaminal epidural steroid No validated outcome measures used
epidural injections (TFESI) in patients with refractory radicular leg pain Small sample size
steroids: An due to herniated nucleus pulposus. Lacked subgroup analysis
outcome Diagnostic methods not described.
study. Total number of patients in the study: 69 Other: no validated functional outcome
Archives of Number of patients in subgroup of relevance to the question: measures utilized
Physical 69
Medicine and
Rehabilitatio Duration of follow-up: average was 20 months (range: six Work group conclusions
n. months - 2.77 years) Potential Level: I
1998;79(11): Downgraded Level: II
1362-1366. Validated outcome measures used: Numeric Rating Scale
(NRS) Conclusions relative to question
This paper provides evidence
Nonvalidated outcome measures used: patient reported that:transforaminal epidural steroid
functional level (excellent, good, fair); successful outcome injections provide good/excellent pain
(good/excellent functional outcome and > 50% reduction in relief and improved level of function by
preinjection NRS); patient satisfaction. patient report in the medium- and long-
term. Successful outcome occurred after
Diagnosis made or confirmed by (check all that apply): an average of 1.8 injections.
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other

Results/subgroup analysis (relevant to question): Successful


outcomes were reported in 75.4% of patients in the medium- to
long-term after receiving an average of 1.8 TFESI for the
treatment of radicular pain due to lumbar disc herniation.
Patient satisfaction with final outcome was 78.3%. A larger
proportion of patients who experienced a successful outcome
had a baseline duration of symptoms less than 36 weeks as
compared to patients with symptoms greater than 36 weeks.

Author conclusions (relative to question): Fluoroscopic


transforaminal epidural steroid injection is an effective
nonsurgical treatment for patients with lumbar disc herniation
and radiculopathy in whom more conservative treatment has
failed.

Murphy DR, Level II Prospective Retrospective Critique of methodology


Hurwitz EL, Patients not enrolled at same point in
McGovern Type of Study Design: cohort their disease
EE. A evidence <80% follow-up
nonsurgical prognostic Stated objective of study: Present the outcomes of patients Follow-up not standardized
approach to with lumbar radiculopathy secondary to lumbar disc herniation No validated outcome measures used
the treated after a diagnosis-based clinical decision rule. Small sample size
management Lacked subgroup analysis
of patients Total number of patients in the study: 60 Diagnostic methods not described.
with lumbar Number of patients in subgroup of relevance to the question: Other:
radiculopathy 37
secondary to
herniated Duration of follow-up: average was 14.5 months Work group conclusions
disk: a Potential Level: II
prospective Validated outcome measures used: Numeric Rating Scale Downgraded Level:
observational (NRS), Bournemouth Disability Questionnaire (BDQ)
cohort study Conclusions relative to question
with follow- Nonvalidated outcome measures used: patient self-rating of This paper provides evidence
up. J outcome (excellent, good, fair, poor, none) that:integrated chiropractic care and
Manipulative physical therapy using a diagnosis- based
Physiol Ther. Diagnosis made or confirmed by (check all that apply): clinical decision rule achieves favorable
Nov-Dec Clinical exam/history long-term outcomes.
2009;32(9):7 Electromyography
23-733. Myelogram
MRI
CT
CT/Myelogram
Other

Results/subgroup analysis (relevant to question):


Patients with lumbar radiculopathy due to disc herniation may
be treated with integrated chiropractic care and physical
therapy using a diagnosis- based clinical decision rule. Good
or excellent medium-term results were reported in 80% of
patients. The average improvement in BDQ scores was 67.4%.
Clinically meaningful improvements in disability were seen in
73% of patients.

Author conclusions (relative to question): There was


meaningful improvement in disability in 73% and
good/excellent patient self-rated outcome reports in 80% of
patients with lumbar radiculopathy secondary to disc herniation
treated with combined chiropractic and physical therapy
techniques following a diagnosis-based clinical decision rule.

Ng LC, Sell Level I Prospective Retrospective Critique of methodology


P. Outcomes Patients not enrolled at same point in
of a Type of Study Design: cohort their disease
prospective evidence <80% follow-up
cohort study prognostic Stated objective of study: Assess the outcome of periradicular Follow-up not standardized
on peri- infiltration for radicular pain in patients with either spinal No validated outcome measures used
radicular stenosis or lumbar disc herniation. Small sample size
infiltration for Lacked subgroup analysis
radicular Total number of patients in the study: 55 lumbar disc Diagnostic methods not described.
pain in herniation patients Other:
patients with Number of patients in subgroup of relevance to the question:
lumbar disc 55
herniation Work group conclusions
and spinal Duration of follow-up: 12 weeks Potential Level: I
stenosis. Eur Downgraded Level:
Spine J. Jul Validated outcome measures used: ODI; Low Back Outcome
2004;13(4):3 Score(LBOS) Conclusions relative to question
25-329. This paper provides evidence that:there is
Nonvalidated outcome measures used: short- to medium-term functional
improvement in patients with radicular pain
Diagnosis made or confirmed by (check all that apply): due to lumbar disc herniation.
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other

Results/subgroup analysis (relevant to question): 58% of


patients with radicular pain due to lumbar disc herniation had
at least a 10% decrease in their ODI at three months. The
average change in ODI at three months was 12%.

Author conclusions (relative to question): Periradicular


infiltration is a safe procedure that produces short to
intermediate term benefit in a significant proportion of patients
with radiculopathy.

Saal JA, Level II Prospective Retrospective Critique of methodology


Saal JS. Patients not enrolled at same point in
Nonoperative Type of Study Design: cohort their disease
treatment of evidence <80% follow-up
herniated prognostic Stated objective of study: Determine whether patients with Follow-up not standardized
lumbar lumbar disc herniation and radiculopathy without stenosis No validated outcome measures used
intervertebral could be treated effectively with aggressive conservative care. Small sample size
disc with Lacked subgroup analysis
radiculopathy Total number of patients in the study: 58 Diagnostic methods not described.
. An outcome Number of patients in subgroup of relevance to the question: Other:
study. Spine 52
(Phila Pa
1976). Apr Duration of follow-up: Average was 31.1 months. Work group conclusions
1989;14(4):4 Potential Level: II
31-437. Validated outcome measures used: ODI Downgraded Level:

Nonvalidated outcome measures used: self-rating scale; Conclusions relative to question


Surgery This paper provides evidence that:patients
with lumbar radicular pain due to herniated
Diagnosis made or confirmed by (check all that apply): nucleus pulposus may obtain good or
Clinical exam/history excellent long-term benefits from medical
Electromyography /interventional treatment.
Myelogram
MRI
CT
CT/Myelogram
Other

Results/subgroup analysis (relevant to question): Median


Oswestry scores for the excellent and good groups were 16.6
and 20, respectively. Good or excellent long-term outcomes
were reported in 50/52 patients (96%).

Author conclusions (relative to question): Herniated nucleus


pulposus of a lumbar intervertebral disc with radiculopathy can
be treated very successfully with aggressive nonoperative
care.

Suri P, Level I Prospective Retrospective Critique of methodology


Hunter DJ, Patients not enrolled at same point in
Jouve C, et Type of Study Design: cohort their disease
al. evidence <80% follow-up
Nonsurgical prognostic Stated objective of study: To determine whether older adults Follow-up not standardized
treatment of (aged greater than 60 years) experience less improvement in No validated outcome measures used
lumbar disk disability and pain with nonsurgical treatment of lumbar disc Small sample size
herniation: herniation than younger adults (less than 60 years). Lacked subgroup analysis
Are Diagnostic methods not described.
outcomes Total number of patients in the study: 164 Other:
different in Number of patients in subgroup of relevance to the question:
older adults? 164
Journal of Work group conclusions
the American Duration of follow-up: six months Potential Level: I
Geriatrics Downgraded Level:
Society.59(3) Validated outcome measures used: ODI, VAS
:423-429. Conclusions relative to question
Nonvalidated outcome measures used: This paper provides evidence
that:conservative treatment improves pain
Diagnosis made or confirmed by (check all that apply): and disability in the majority of patients
Clinical exam/history regardless of age.
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other

Results/subgroup analysis (relevant to question): Adjusted


mean improvement in older and younger adults was 31 versus
33 (P=0.63) for ODI, 4.5 versus 4.5 (P=0.99) for leg pain, and
2.4 versus 2.7 for back pain (P=0.69).

Author conclusions (relative to question): older adults suffering


from subacute radicular pain (less than 12 weeks),
demonstrated improvements in disability and pain with
nonsurgical treatment that were not significantly different from
those seen in younger adults over a six month period.

Thomas KC, Level II Prospective Retrospective Critique of methodology


Fisher CG, Patients not enrolled at same point in
Boyd M, Type of Study Design: cohort their disease
Bishop P, evidence <80% follow-up
Wing P, prognostic Stated objective of study: To assess health-related quality of Follow-up not standardized
Dvorak MF. life (HRQOL) following either lumbar discectomy or No validated outcome measures used
Outcome medical/interventional care for lumbar disc protrusion causing Small sample size
evaluation of radiculopathy. Lacked subgroup analysis
surgical and Diagnostic methods not described.
nonsurgical Total number of patients in the study: 497 Other: wait time for surgery affected
management Number of patients in subgroup of relevance to the question: end point comparison times.
of lumbar 333 operative; 164 medical/interventional (excluded injection-
disc based therapy)
protrusion Work group conclusions
causing Duration of follow-up: 12 months Potential Level: II
radiculopathy Downgraded Level:
. Spine. Validated outcome measures used: The North American
2007;32(13): Spine Society (NASS) Lumbar Spine Follow-Up Questionnaire, Conclusions relative to question
1414-1422. Version 2.0; NASS Neurogenic Symptom Score (NSS); SF-36 This paper provides evidence that:change
in the neurogenic symptom score, from
Nonvalidated outcome measures used: baseline to follow-up, is not associated
with type of treatment received,
Diagnosis made or confirmed by (check all that apply): medical/interventional care or delayed
Clinical exam/history surgery, in this cohort of patients.
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other

Results/subgroup analysis (relevant to question): The mean


baseline score was lower in the surgical group (30.9
medical/interventional vs. 25.3 surgical), indicative of greater
baseline disability. The scores at follow-up (six months
postsurgery for the surgical group vs. 12 months postbaseline
for the medical/interventional group) were approximately
equivalent (44.6 medical/interventional, 43.8 surgical),
suggesting that both groups of patients improved over time.
Within the timeframe of the study, however, neither group
returned to an age-matched normative NSS (51.6). While the
surgical group improved a mean of 4.77 points more (95%
confidence interval [CI], 2.08 7.46, P = 0.001) than the
medical/interventional group, this difference was reduced to
0.95 points and became nonsignificant after adjustment for
confounders. From the NASS instrument, the outcome
change in pain and disability score (PDS) was significantly
associated with treatment group, with the surgical group
experiencing an average score change of 3.46 points greater
than the medical/interventional group (P= 0.04; 95% CI, 0.17
6.75). From the SF-36, the outcomes change in mental health
(MH) score and change in mental component score (MCS)
were also significantly associated with treatment group, with
the surgical group experiencing an average posttreatment
score improvement of 3.01 and 3.52 points greater,
respectively, than the medical/interventional group (MH: P
=0.04; 95% CI, 0.19 5.83; MCS P=0.02; 95% CI, 0.48 6.56).
Although three secondary outcomes, the NASS PDS, the MH
domain of the SF-36, and the MCS of the SF-36 showed
statistically significant differences favoring surgical treatment,
in each case, the effect sizes were small and were not felt to
be clinically significant.

Author conclusions (relative to question): We found that


patients treated either surgically or nonsurgically for lumbar
disc protrusion causing radiculopathy showed no significant
difference in change in NASS NSS scores at follow-up. Clinical
outcome of delayed surgery and nonsurgical care may be no
different within one year of baseline assessment.
Question #12:

b. Are there prognostic factors (eg, age, duration or severity of symptoms) that make it more likely that a patient
with lumbar disc herniation with radiculopathy will have good/excellent functional outcomes at short (weeks to 6
months), medium (6 months - 2 years) and long-term (greater than 2 years) following medical/interventional
treatment?

Article Level
(Alpha by of Description of study Conclusion
Author) evidence

Ahn Y, Lee Level II Prospective Retrospective Critique of methodology


SH, Lee JH, Patients not enrolled at same
Kim JU, Liu Type of Study Design: case series point in their disease
WC. evidence <80% follow-up
Transforamin prognostic Stated objective of study: To assess the clinical outcome, prognostic Follow-up not standardized
al factors and the technical pitfalls of percutaneous endoscopic lumbar No validated outcome
percutaneou discectomy for upper lumbar disc herniation. measures used
s endoscopic Small sample size
lumbar Total number of patients in the study: 45 Lacked subgroup analysis
discectomy Number of patients in subgroup of relevance to the question: 45 Diagnostic methods not
for upper described.
lumbar disc Duration of follow-up: 25-52 months with a mean of 38.8 months Other:
herniation:
clinical Validated outcome measures used: Visual Analog Scale (VAS)
outcome, Work group conclusions
prognostic Nonvalidated outcome measures used: The patients status was Potential Level: II
factors, and classified as excellent (Prolo scale score, 910), good (78), fair (56), Downgraded Level:
technical and poor (four or less).
consideration Conclusions relative to question
. Acta Diagnosis made or confirmed by (check all that apply): This paper provides evidence
Neurochir Clinical exam/history that: transforaminal endoscopic
(Wien). Mar Electromyography percutaneous discectomy can be
2009;151(3): Myelogram effective for treatment of upper
199-206. MRI lumbar disc herniations at L1-2
CT and L2-3, and that a younger age
CT/Myelogram (less than 45 years) correlates
Other with a higher likelihood of
excellent outcome. Patients with
Results/subgroup analysis (relevant to question): Based on the Prolo shorter symptom durations (less
scale, the outcomes were excellent in 21 of 45 patients (46.7%), good than six months) may have a
in 14 patients (31.1%), fair in six patients (13.3%), and poor in four better outcome.
patients (8.9%). The combined rate of excellent or good outcome at
the final follow-up was 77.8%. The mean VAS for radicular pain was
8.38 1.22, and after operation decreased to 2.36 1.65 (P <
0.0001).

The age of the patient and the duration of symptoms were found to be
related to outcome. Patients younger than 45 years old tended to
obtain better outcomes than older patients (75% vs. 36.4%, P <
0.05). An excellent outcome was seen in 65% of patients with shorter
symptom durations (less than six months) but was less at 32% (six
months or longer) (P<0.05).

Age younger than 45 and a lateral disc herniation were significantly


related to the outcome. After multivariate analysis, the shorter
symptom duration was not associated with outcome because of a
strong association with a lateral disc herniation.

Author conclusions (relative to question): Patient selection and an


anatomically modified surgical technique promote a more successful
outcome after percutaneous endoscopic discectomy for upper lumbar
disc herniation.

Ahn Y, Lee Level II Prospective Retrospective Critique of methodology


SH, Park Patients not enrolled at same
WM, Lee HY, Type of Study Design: case series point in their disease
Shin SW, evidence <80% follow-up
Kang HY. prognostic Stated objective of study: To evaluate the efficacy of endoscopic Follow-up not standardized
Percutaneou discectomy for recurrent disc herniations and to determine the No validated outcome
s endoscopic prognostic factors affecting surgical outcome. measures used
lumbar Small sample size
discectomy Total number of patients in the study: 43 Lacked subgroup analysis
for recurrent Number of patients in subgroup of relevance to the question: 43 Diagnostic methods not
disc described.
herniation: Duration of follow-up: The mean follow-up period was 31 months (24 Other:
surgical 39 months)
technique,
outcome, Validated outcome measures used: Visual Analog Scale (VAS) Work group conclusions
and Potential Level: II
prognostic Nonvalidated outcome measures used: MacNab criteria Downgraded Level:
factors of 43
consecutive Diagnosis made or confirmed by (check all that apply): Conclusions relative to question
cases. Spine Clinical exam/history This paper provides evidence
(Phila Pa Electromyography that: percutaneous endoscopic
1976). Aug Myelogram lumbar discectomy is effective for
15 MRI recurrent disc herniation in
2004;29(16): CT selected cases. Patients younger
E326-332. CT/Myelogram than 40 years, with shorter
Other symptom duration (less than three
months) and without concurrent
Results/subgroup analysis (relevant to question): Based on the lateral recess stenosis tended to
MacNab criteria, the surgical outcomes were rated as follows: have better outcomes.
excellent in 12 patients (27.9%), good in 23 (53.5%), fair in six
(13.9%), and poor in two (4.7%). Therefore, the percentage of The work group debated the
successful outcomes was 81.4%, whereas the rate of improvement eligibility of this paper for inclusion
was 95.3%. The preoperative mean VAS was 8.72 +/- 1.20, which in the guideline. Several
decreased to 2.58 +/- 1.55 at the final follow up (P<0.0001). members opposed its inclusion
because the paper evaluated the
Patients' age and duration of symptoms were strongly related with treatment of recurrent herniations.
surgical outcome. Patients younger than 40 years showed better Proponents pointed out that
outcomes (P = 0.036). Cases with duration of symptoms of less than patients included in the study had
months also had a tendency to have successful outcomes (P = 0.028) a mean pain-free interval after
their previous surgery of 63
In consideration of the radiologic findings, the presence of concurrent months, ranging from six to 186
lateral recess stenosis was the only factor affecting the outcome months. Furthermore, the
(lateral recess stenosis was defined as a lateral recess measurement question serving as the basis for
of less than 3 mm). Among six patients with lateral recess stenosis, the literature review and guideline
only two (33.3%) had successful outcomes, whereas 33 (89.2%) of the formulation did not specifically
remaining 37 without lateral recess stenosis had successful outcomes exclude recurrent herniation
(P = 0.007). (although all committee members
inferred that the guideline
development was intended to
Author conclusions (relative to question): Percutaneous endoscopic address virgin disc herniations).
lumbar discectomy is effective for recurrent disc herniation in selected
cases. Patients younger than 40 years, patients with duration of
symptoms of less than three months, and patients without concurrent
lateral recess stenosis tended to have better outcomes.

Choi SJ, Level III Prospective Retrospective Critique of methodology


Song JS, Patients not enrolled at same
Kim C, et al. Type of Study Design: case control point in their disease
The use of evidence <80% follow-up
magnetic prognostic Stated objective of study: To compare MRI findings in patients who Follow-up not standardized
resonance responded to transforaminal epidural steroid injections with those who No validated outcome
imaging to did not. measures used
predict the Small sample size
clinical Total number of patients in the study: 68 Lacked subgroup analysis
outcome of Number of patients in subgroup of relevance to the question: Diagnostic methods not
non-surgical Responders (R)=41; Non-Responders (NR)=27 described.
treatment for Other: no functional outcomes;
lumbar Duration of follow-up: mean 3.6 months follow-up range from seven
interverterbal days to 24 months
disc Validated outcome measures used: Visual Numeric Scale
herniation.
Korean J. Nonvalidated outcome measures used: patient satisfaction (0-poor, 1- Work group conclusions
Radiol. Mar- fair, 2-good, 3-very good, 4-excellent) Potential Level: II
Apr Downgraded Level: III
2007;8(2):15 Diagnosis made or confirmed by (check all that apply):
6-163. Clinical exam/history Conclusions relative to question
Electromyography This paper provides evidence
Myelogram that:there was no significant
MRI difference between responders
CT and nonresponders with regard to
CT/Myelogram size of disc herniation, association
Other with spinal stenosis, and type of
herniation: extrusion, protrusion or
Results/subgroup analysis (relevant to question): Successful sequestration. Radicular leg pain
outcome(responders) was defined as patient satisfaction score greater due to a herniated disc in the
than two and a pain reduction score greater than 50% on the last visit. subarticular region and Grade 3
There was no significant difference between the responders and nerve root compression may not
nonresponders in terms of type, hydration and size of the herniated respond to transforaminal epidural
disc or an association with spinal stenosis. There was a significant steroid injections.
difference among nonresponders in terms of the location of the
herniated disc and grade of nerve compression. Nonresponders
included all six patients with a subarticular disc herniation and two-
thirds of the patients with Grade 3 nerve root compression. Grade 3
nerve root compression showed more unsatisfactory results than
Grade 1 nerve root compression.

Author conclusions (relative to question): Magnetic resonance


imaging may have a role in predicting response to transforaminal
epidural steroid injections in patients with lumbar disc herniation.

Ghahreman Level II Prospective Retrospective Critique of methodology


A, Bogduk N. Patients not enrolled at same
Predictors of Type of Study Design: case series point in their disease
a favorable evidence <80% follow-up
response to prognostic Stated objective of study: To identify clinical and radiographic features Follow-up not standardized
transforamin predictive of a favorable response to transforaminal injection of No validated outcome
al injection of steroids. measures used
steroids in Small sample size
patients with Total number of patients in the study: 71 Lacked subgroup analysis
lumbar Number of patients in subgroup of relevance to the question: 38: Diagnostic methods not
radicular favorable response to transforaminal epidural steroid injection; 33: no described.
pain due to response to transforaminal epidural steroid injection. Other: no functional outcomes;
disc short duration of follow-up.
herniation. Duration of follow-up: one month
Pain Med.
Jun;12(6):87 Validated outcome measures used: Visual Analog Scale (VAS) Work group conclusions
1-879. Potential Level: II
Nonvalidated outcome measures used: Downgraded Level:

Diagnosis made or confirmed by (check all that apply): Conclusions relative to question
Clinical exam/history This paper provides evidence
Electromyography that:
Myelogram transforaminal epidural steroid
MRI injection is more likely to be
CT successful in patients with MRI
CT/Myelogram evidence of low grade nerve root
Other compression. The clinical features
and disc morpology are
Results/subgroup analysis (relevant to question): insignificant.
Favorable response was defined as a reduction of at least 50% in VAS
score lasting longer than one month after treatment. No clinical feature
was predictive of outcome: duration of symptoms, neurologic
symptoms or abnormal neurologic exam. The morphology of the disc
herniation was of no significance. The MRI grade of nerve root
compression was a significant prognostic factor for the treatment of
paracentral and foraminal disc herniations. Pooling the paracentral
and foraminal nerve root compression patients into a single group, a
favorable response occurred for 75% of the patients with low grade
root compression compared to 26% of patients with high grade nerve
root compression.

Author conclusions (relative to question): In patients with low grade


nerve root compression , there is a 75% favorable response rate to a
transforaminal lumbar epidural steroid injection.

Suri P, Level I Prospective Retrospective Critique of methodology


Hunter DJ, Patients not enrolled at same
Jouve C, et Type of Study Design: cohort point in their disease
al. evidence <80% follow-up
Nonsurgical prognostic Stated objective of study: To determine whether older adults (aged 60 Follow-up not standardized
treatment of or older) experience less improvement in disability and pain with No validated outcome
lumbar disk medical/interventional treatment of lumbar disc herniation than measures used
herniation: younger adults (<60). Small sample size
Are Lacked subgroup analysis
outcomes Total number of patients in the study: 133 Diagnostic methods not
different in Number of patients in subgroup of relevance to the question: 89 young described.
older adults? (<60), 44 older (60 or older) Other: heterogeneic
Journal of treatments; short (six month)
the American Duration of follow-up: six months follow-up
Geriatrics
Society.59(3) Validated outcome measures used: Oswestry Disability Index;
:423-429. Numeric Pain Scale Leg; Numeric Pain Scale Back Work group conclusions
Potential Level: I
Nonvalidated outcome measures used: Downgraded Level:

Diagnosis made or confirmed by (check all that apply): Conclusions relative to question
Clinical exam/history This paper provides evidence
Electromyography that:age has no impact on pain
Myelogram relief from medical/interventional
MRI treatment outcomes. Race, sex,
CT employment status, prior low back
CT/Myelogram pain, tobacco history, comorbidity,
Other symptom duration of less than 12
weeks, baseline Oswestry,
Results/subgroup analysis (relevant to question): There was no herniation level, herniation
significant difference in six month Oswestry Disability Index and back location, and herniation
and leg Numeric Pain Scale outcome measures among those younger morphology are not significantly
or older than 60 years who received medical/interventional treatment related to outcome.
for radicular pain due to a lumbar disc herniation. Multivariate analysis
of sex, race, employment status, prior low back pain, tobacco history,
comorbidity, symptom duration of less than 12 weeks, baseline
Oswestry score, herniation level, herniation type, herniation location,
herniation morphology, adjusted baseline leg pain and adjusted
baseline back pain were not significantly related to outcome at six
months.

Author conclusions (relative to question): Age greater than 60 vs. less


than 60 did not have an effect on outcomes at six months in patients
with lumbar disc herniation who received medical/interventional
treatment.
Question #13A:
Are there signs or symptoms associated with lumbar radiculopathy that predict a favorable surgical
outcome?

Article Level
(Alpha by of Description of study Conclusion
Author) evidence

Abramovitz Level III Prospective Retrospective Critique of methodology:


JN, Neff SR. Nonconsecutive patients
Lumbar disc Study design: comparative Nonrandomized
surgery: Type of Nonmasked reviewers
results of the evidence Stated objective of study: evaluate the indications and Nonmasked patients
Prospective prognostic efficacy of lumbar discectomy with or without facetectomy No validated outcome measures used
Lumbar stratified by pre-operative risk factors Small sample size
Discectomy <80% follow-up
Study of the Type of treatment(s): lumbar discectomy, with or without Lacked subgroup analysis
Joint Section microscope, with or without facetectomy Diagnostic method not stated
on Disorders Other: diagnostic criteria not provided
of the Spine Total number of patients: 740
and Number of patients in relevant subgroup(s): unknown
Peripheral Work group conclusions
Nerves of the Consecutively assigned? Yes Potential Level: II
American Downgraded Level: III
Association Duration of follow-up: 12 months (but three month data
of fully analyzed in 533 patients) Conclusions relative to question
Neurological This paper provides evidence that:patients
Surgeons Validated outcome measures used (list): none with an absence of back pain, an absence
and the of a work-related injury, presence of a
Congress of Nonvalidated outcome measures used (list): outcomes straight leg raising test, distribution of
Neurological defined as either poor or good as defined by study radicular pain including the foot, reflex
Surgeons. asymmetry, and absence of back pain with
Neurosurger Diagnosis made by: straight leg raising have a better prognosis
y. Aug Clinical exam/history for good outcomes following lumbar
1991;29(2):3 Electromyography discectomy. The use of the operating
01-307; Myelogram microscope may decrease the need for
discussion MRI facetectomy and improve outcomes in
307-308. CT patients at risk for chronic low back pain.
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question):

Author conclusions (relative to question): Risk factors


based on clinical examination and history can predict
outcomes following lumbar discectomy. Facetectomy
may lead to a higher incidence of chronic low back pain.

Ahn UM, Ahn Level IV Prospective Retrospective Critique of methodology


NU, Patients not enrolled at same point in
Buchowski Type of Study Design: meta-analysis their disease
JM, Garrett evidence <80% follow-up
ES, Sieber prognostic Stated objective of study: look at risk factors for poor Follow-up not standardized
AN, Kostuik outcomes following decompressive surgery for cauda No validated outcome measures used
JP. Cauda equina syndrome including the influence of timing of Small sample size
equina decompression Lacked subgroup analysis
syndrome Diagnostic methods not described.
secondary to Total number of patients in the study: 322 Other:
lumbar disc Number of patients in subgroup of relevance to the
herniation: a question: 322
meta- Work group conclusions
analysis of Duration of follow-up: variable Potential Level: IV
surgical Downgraded Level:
outcomes. Validated outcome measures used:
Spine (Phila Conclusions relative to question
Pa 1976). Nonvalidated outcome measures used: reported This paper provides evidence that:chronic
Jun 15 resolution of deficits in bowel or bladder function, motor low back pain prior to the onset of cauda
2000;25(12): strength, sensory disturbance, and ongoing pain equina syndrome, advanced age, and
1515-1522. sphincter disturbance are associated with
Diagnosis made or confirmed by (check all that apply): poorer outcomes following decompression.
Clinical exam/history Treating patients with cauda equina
Electromyography syndrome within 48 hours of the onset of
Myelogram symptoms improves outcomes in resolution
MRI of sensory deficit, motor deficit, urinary
CT function and rectal function, but not pain.
CT/Myelogram
Other

Results/subgroup analysis (relevant to


question): Multivariate regression analysis was
performed looking at 13 preoperative variables including
age, gender, history of previous surgery, history of
chronic back pain, sudden onset, duration of chronic
symptoms, work status, history of trauma, presence of
sciatica, preoperative weakness, sensory deficit, reflex
loss, and sphnicter disturbance. Timing of
decompression was divided into five categories and the
analysis was repeated.

Author conclusions (relative to question): Chronic low


back pain prior to the onset of cauda equina syndrome,
advanced age, and sphincter disturbance are associated
with poorer outcomes following decompression. Earlier
decompression in cauda equina syndrome (less than 48
hours) was associated with better outcomes.

Buchner M, Level IV Prospective Retrospective Critique of methodology:


Schiltenwolf Nonconsecutive patients
M. Cauda Study design: case series Nonrandomized
equina Type of Nonmasked reviewers
syndrome evidence Stated objective of study: examine the incidence of Nonmasked patients
caused by prognostic urinary functional recovery related to the variables of No validated outcome measures used
intervertebral preoperative symptoms and timing of treatment for cauda Small sample size
lumbar disk equina syndrome. <80% follow-up
prolapse: Lacked subgroup analysis
mid-term Type of treatment(s): laminectomy/decompression Diagnostic method not stated
results of 22 Other: evaluated by review of medical
patients and Total number of patients: 28 records and nine by phone interview
literature Number of patients in relevant subgroup(s): 22
review.
Orthopedics. Consecutively assigned? No Work group conclusions
Jul Potential Level: IV
2002;25(7):7 Duration of follow-up: mean three years and nine months, Downgraded Level:
27-731. minimum 13 months, maximum 18 years
Conclusions relative to question
Validated outcome measures used (list): none This paper provides evidence
that:decompression results in improvement
Nonvalidated outcome measures used (list): recovery of in symptoms for the majority of patients
neurological deficits, in particular bladder dysfunction with cauda equina syndrome. Better
outcomes were seen in women as well as
Diagnosis made by: in patients without motor weakness or
Clinical exam/history complete saddle anesthesia. In this series,
Electromyography timing of decompression did not influence
Myelogram outcome, however there was a large
MRI proportion of patients with chronic
CT symptoms included in the series.
CT/Myelogram
Other: varied and included MRI, CT, or myelography in
case series spanning several decades

Results/subgroup analysis (relevant to


question): decompression results in improvement in
symptoms for the majority of patients with cauda equina
syndrome. Better outcomes were seen in women as well
as in patients without motor weakness or complete saddle
anesthesia. In this series, timing of decompression did not
influence outcome.

Author conclusions (relative to question): decompression


results in improvement in symptoms for the majority of
patients with cauda equina syndrome. Better outcomes
were seen in women as well as in patients without motor
weakness or complete saddle anesthesia. In this series,
timing of decompression did not influence outcome.

Chaichana Level I Prospective Retrospective Critique of methodology


KL, Patients not enrolled at same point in
Mukherjee D, Type of Study Design: cohort their disease
Adogwa O, evidence <80% follow-up
Cheng JS, prognostic Stated objective of study: assess the role of depression Follow-up not standardized
McGirt MJ. and somatization in predicting outcomes following surgery No validated outcome measures used
Correlation for lumbar disc herniation. Small sample size
of Lacked subgroup analysis
preoperative Total number of patients in the study: 67 Diagnostic methods not described.
depression Number of patients in subgroup of relevance to the Other:
and somatic question: 67
perception
scales with Duration of follow-up: one year Work group conclusions
postoperativ Potential Level: I
e disability Validated outcome measures used: SF-36, VAS pain, Downgraded Level:
and quality of and Oswestry Disability Index
life after Conclusions relative to question
lumbar Nonvalidated outcome measures used: This paper provides evidence that:despite
discectomy. similar improvements in leg pain, patients
J Neurosurg Diagnosis made or confirmed by (check all that apply): with pre-operative depression or
Spine. Clinical exam/history somatization have poorer outcomes as
Feb;14(2):26 Electromyography measured by quality of life indices or
1-267. Myelogram functional disability scales compared with
MRI similar patients without depression or
CT somatization.
CT/Myelogram
Other

Results/subgroup analysis (relevant to


question): Patients with pre-operative evidence of
depression or somatization did poorly compared to
remainder of cohort.

Author conclusions (relative to question): Depression and


somatization are negative prognostic factors for good
outcomes following lumbar discectomy.

Kohlboeck Level II Prospective Retrospective Critique of methodology


G, Greimel Patients not enrolled at same point in
KV, Type of Study Design: cohort their disease
Piotrowski evidence <80% follow-up
WP, et al. prognostic Stated objective of study: evaluate patient related factors Follow-up not standardized
Prognosis of on outcome of surgery No validated outcome measures used
multifactorial Small sample size
outcome in Total number of patients in the study: 58 Lacked subgroup analysis
lumbar Number of patients in subgroup of relevance to the Diagnostic methods not described.
discectomy - question: 48 Other:
A
prospective Duration of follow-up: six months
longitudinal Work group conclusions
study Validated outcome measures used: SF-36, Hannover Potential Level: I
investigating Mobility Questionnaire, VAS Pain Downgraded Level: II
patients with
disc Nonvalidated outcome measures used: return to work, Conclusions relative to question
prolapse. number of pain locations This paper provides evidence that:a
Clin. J. Pain. preoperative straight leg raising sign is
Nov-Dec Diagnosis made or confirmed by (check all that apply): associated with better outcomes following
2004;20(6):4 Clinical exam/history decompression for radiculopathy.
55-461. Electromyography Preoperative depression is associated with
Myelogram worse outcomes. Outcomes are also
MRI effected by work status. Preoperative
CT medical, psychological, educational and
CT/Myelogram economic variables can predict outcomes
Other in most patients.

Results/subgroup analysis (relevant to


question): Patients with depression did worse compared
to remainder of cohort.

Author conclusions (relative to question): Psychosocial


variables influence outcomes following discectomy as do
examination findings. A positive pre-operative straight leg
raising sign is a good prognostic sign whereas depression
is associated with worse outcomes.

McCarthy Level IV Prospective Retrospective Critique of methodology


MJ, Aylott Patients not enrolled at same point in
CE, Grevitt Type of Study Design: case series their disease
MP, Hegarty evidence <80% follow-up
J. Cauda prognostic Stated objective of study: identify factors affecting long- Follow-up not standardized
equina term results in cauda equina syndrome No validated outcome measures used
syndrome: Small sample size
factors Total number of patients in the study: 54 Lacked subgroup analysis
affecting Number of patients in subgroup of relevance to the Diagnostic methods not described.
long-term question: 48 follow-up Other:
functional
and Duration of follow-up: two years
sphincteric Work group conclusions
outcome. Validated outcome measures used: ODI, SF36, Low Potential Level: IV
Spine (Phila Back Outcome Score, VAS Downgraded Level:
Pa 1976).
Jan 15 Nonvalidated outcome measures used: neurological Conclusions relative to question
2007;32(2):2 examination, bladder dysfunction, sexual dysfunction This paper provides evidence that:Timing
07-216. of surgery does not influence outcome
Diagnosis made or confirmed by (check all that apply): following decompression for cauda equina
Clinical exam/history syndrome. Leg weakness at onset and
Electromyography female sex were associated with persistent
Myelogram deficits. Timing of decompression did not
MRI significantly influence outcome in this case
CT series, however there was a trend towards
CT/Myelogram better outcomes in patients treated within
Other 48 hours. It must be noted, however that
virtually all patients who presented acutely
Results/subgroup analysis (relevant to question): Timing were treated within 48 hours.
of surgery does not influence outcome following
decompression for cauda equina syndrome. Leg
weakness at onset and female sex were associated with
persistent deficits.
Author conclusions (relative to question): Timing of
surgery does not influence outcome following
decompression for cauda equina syndrome. Leg
weakness at onset and female sex were associated with
persistent deficits.

Olivero WC, Level IV Prospective Retrospective Critique of methodology


Wang H, Patients not enrolled at same point in
Hanigan WC, Type of Study Design: case series their disease
et al. Cauda evidence <80% follow-up
equina prognostic Stated objective of study: assess outcome of patients Follow-up not standardized
syndrome operated upon for cauda equina syndrome focusing on No validated outcome measures used
(CES) from sphincter and motor disturbances Small sample size
lumbar disc Lacked subgroup analysis
herniations. J Total number of patients in the study: 31 Diagnostic methods not described.
Spinal Disord Number of patients in subgroup of relevance to the Other:
Tech. May question: 29
2009;22(3):2
02-206. Duration of follow-up: mean five years Work group conclusions
Potential Level: IV
Validated outcome measures used: no Downgraded Level:

Nonvalidated outcome measures used: patients surveyed Conclusions relative to question


regarding motor strength and bladder function This paper provides evidence that:the vast
majority of patients improve following
Diagnosis made or confirmed by (check all that apply): decompression for cauda equina
Clinical exam/history syndrome. There was no difference in
Electromyography outcomes between patients operated upon
Myelogram within 24 hours, between 24 and 48 hours,
MRI and greater than 48 hours.
CT
CT/Myelogram
Other

Results/subgroup analysis (relevant to question): the vast


majority of patients improve following decompression for
cauda equina syndrome. There was no difference in
outcomes between patients operated upon within 24
hours, between 24 and 48 hours, and greater than 48
hours.

Author conclusions (relative to question): The vast


majority of patients improve following decompression for
cauda equina syndrome. There was no difference in
outcomes between patients operated upon within 24
hours, between 24 and 48 hours, and greater than 48
hours.
Question #14:
When is the optimal timing for surgical intervention?

Article Level
(Alpha by of Description of study Conclusion
Author) evidence

Ahn UM, Ahn Level IV Prospective Retrospective Critique of methodology:


NU, Nonconsecutive patients
Buchowski Study design: meta-analysis Nonrandomized
JM, Garrett Type of Nonmasked reviewers
ES, Sieber evidence Stated objective of study: To determine the relationship Nonmasked patients
AN, Kostuik therapeutic betweentime to decompression after onset of cauda No validated outcome measures used
JP. Cauda equina syndromeand clinical outcome, and to identify Small sample size
equina preoperative variables that were associated with <80% follow-up
syndrome outcomes. Lacked subgroup analysis
secondary to Diagnostic method not stated
lumbar disc Type of treatment(s): surgical decompression Other: Studies included case
herniation: a reports/series with no obvious Level I-II
meta- Total number of patients: 322 studies
analysis of Number of patients in relevant subgroup(s): 322
surgical
outcomes. Consecutively assigned? No Work group conclusions
Spine (Phila Potential Level: IV
Pa 1976). Duration of follow-up: Downgraded Level:
Jun 15
2000;25(12): Validated outcome measures used (list): resolution of Conclusions relative to question
1515-1522. pain, resolution of sensory deficit, resolution of motor This paper provides evidence that: treating
deficit, resolution of urinary deficit, resolution of sexual patients with cauda equina syndrome within
dysfunction, resolution of rectal dysfunction; motor, 48 hours of the onset of symptoms improves
sensory, rectal and urinary recoveries (recorded as outcomes in resolution of sensory deficit,
positive only if full recovery was reported; incomplete motor deficit, urinary function and rectal
recovery was recorded as a failure to recover) function, but not pain.

Nonvalidated outcome measures used (list):


Diagnosis made by:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): There


was no significant difference in outcomes among patients
that had decompression performed at more than 48 hours
after onset. There was a significant improvement in
resolution of sensory deficit, resolution of motor deficit,
resolution of urinary incontinence and resolution of rectal
dysfunction when decompression was performed
within 48 hours compared with after 48 hours. Specifically,
patients who underwent surgery 48 hours or more after
onset of cauda equina syndrome, when compared with
patients who underwent surgery within 48 hours, were at
2.5 times the risk of continuing to have a urinary deficit (P
= 0.01, CI 1.195.26); 9.1 times the risk of continuing to
have a motor deficit (P=0.01, CI 2.5633.33); 9.1 times the
risk of continuing to have rectal dysfunction (P=0.003, CI
2.1333.3); and 3.5 times the risk of continuing to have a
sensory deficit (P=0.005, CI 1.458.33). There was no
statistically significant difference in outcomes related to
continuing pain (p=0.338).

Author conclusions (relative to question): There is a


significant advantage to treating patients within 48 hours
as opposed to later than 48 hours, with improved
outcomes in resolution of sensory deficit, motor deficit,
urinary function and rectal function. There was no
significant difference in outcomes related to continuing
pain. The presence of preoperative chronic low back pain
is associated with poorer outcomes in urinary and rectal
function. Preoperative rectal dysfunction is associated with
a worsened outcome in urinary continence. In addition,
older patients are less likely to fully regain sexual function
after surgery.

Buchner M, Level IV Prospective Retrospective Critique of methodology:


Schiltenwolf Nonconsecutive patients
M. Cauda Study design: case series Nonrandomized
equina Type of Nonmasked reviewers
syndrome evidence Stated objective of study: Determine if time from onset of Nonmasked patients
caused by therapeutic the symptoms of cauda equina syndrome and time of No validated outcome measures used
intervertebral operative intervention affects outcome of urinary, motor, or Small sample size
lumbar disk sensory function. <80% follow-up
prolapse: Lacked subgroup analysis
mid-term Type of treatment(s): decompression Diagnostic method not stated
results of 22 Other: Motor and sensory function were
patients and Total number of patients: 28 reported as having recovered but how
literature Number of patients in relevant subgroup(s): 22 baseline and postoperative function were
review. determined was not reported
Orthopedics. Consecutively assigned? Yes
Jul
2002;25(7):7 Duration of follow-up: 13 months to eight years (mean Work group conclusions
27-731. three years nine months) Potential Level: IV
Downgraded Level:
Validated outcome measures used (list):
Conclusions relative to question
Nonvalidated outcome measures used (list): postoperative This paper provides evidence that:the time
urinary function (Gleave and Macfarlane criteria), motor between the onset of symptoms of cauda
function (not defined or graded), sensory function (not equina syndrome and surgical
defined or graded), saddle anesthesia (not otherwise decompression does not affect the
defined or graded) subsequent outcome of urinary, motor or
sensory function.
Diagnosis made by:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Ten of


22 patients had "excellent" results and regained full
subjective urinary capacity within the immediate
postoperative period. Seven patients had good results and
regained urinary continence within the follow-up period.
Four patients had "fair" results (not further explained), only
one patient had incomplete recovery of bladder function
during follow-up with a persisting stress incontinence. No
patient underwent urodynamic testing preoperatively, and
only seven of 22 had studies postoperatively. In 13 of 17
patients with preoperative motor deficits, recovery was
noted during follow-up. Fourteen of 21 patients with pre-
operative sensory deficits recovered. Thirteen of 15
patients with complete perianal and saddle anesthesia
regained perianal sensation postoperatively. A statistically
better postoperative outcome was correlated with: female
sex (p=.03), absence of preoperative complete perianal or
saddle anesthesia (p=.03) and absence of preoperative
radicular motor deficit (p=.05) Age, previous lumbar
surgery, preoperative sciatica of over six months duration,
acute or chronic onset of symptoms, preoperative fecal
incontinence or reflex deficit, preoperative uni- or bilateral
sciatic pain, time of postoperative recovery of sensory
function and time between onset of urinary symptoms and
surgery did not have a statistically significant correlation
with postoperative outcomes.

Author conclusions (relative to question): The present


study did not find a difference in clinical outcome of
urinary, motor, or sensory function relative to the time of
the onset of symptoms of cauda equina syndrome and
time to surgical decompression.

Fisher C, Level II Prospective Retrospective Critique of methodology:


Noonan V, Nonconsecutive patients
Bishop P, et Study design: comparative Nonrandomized
al. Outcome Type of Nonmasked reviewers
evaluation of evidence Stated objective of study: Assess health related quality of Nonmasked patients
the operative therapeutic life (HRQOL) and the appropriateness of surgery in No validated outcome measures used
management patients who have undergone elective lumbar discectomy. Small sample size
of lumbar <80% follow-up
disc Type of treatment(s): decompression Lacked subgroup analysis
herniation Diagnostic method not stated
causing Total number of patients: 82 Other: Patients enrolled at different points
sciatica. J Number of patients in relevant subgroup(s): 77 available in their disease
Neurosurg. for follow-up at six months, 71 were available at one year
Apr
2004;100(4 Consecutively assigned? Yes Work group conclusions
Suppl Potential Level: II
Spine):317- Duration of follow-up: six months, one year Downgraded Level:
324.
Validated outcome measures used (list): NASS lumbar Conclusions relative to question
spine instrument, SF-36, HRQOL This paper provides evidence that:a duration
of symptoms greater than six months is
Nonvalidated outcome measures used (list): associated with less improvement following
microdiscectomy compared to patients with
Diagnosis made by: symptom duration less than six months when
Clinical exam/history patients are managed with usual care prior to
Electromyography surgery.
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): There


was little change between the six month and one year
Health Related Quality of Life (HRQOL) scores. Clinically
significant improvement (greater than 20%) occurred in
77% of patients according to the NSS and 82% according
to the PDS, whereas in 10% of patients NSS declined, and
in 3% the PDS declined. Both of the NASS scores were
significantly lower than normative values after six months
and one year (p=0.001). The SF-36 MCS at one year was
not significantly different from the normative data, which
indicated that the MCS had recovered to normal. The
mean PCS at six months and one year was significantly
less than normative data (both <0.001). Individual scores
related to pain and physical status were significantly lower
than normative scores. Adjusted for age, when time
between symptom onset and surgery was greater than
6.1-9 months, 9.1-12 months and greater than 12 months,
the PDS was significantly worse at one year compared
with when this period was zero to three months (p=0.04,
0.024, and 0.029, respectively).

Author conclusions (relative to question): NSS and PDS


showed very significant improvement at six months, with
little change between six months and one year after
surgery. The SF 36 scales demonstrated the greatest
improvement. Prolonged duration of preoperative
symptoms appears to impact negatively on patient
outcome.

Ghahreman Level IV Prospective Retrospective Critique of methodology:


A, Ferch RD, Nonconsecutive patients
Rao P, Study design: case series Nonrandomized
Chandran N, Type of Nonmasked reviewers
Shadbolt B. evidence Stated objective of study: assess the rate and extent of the Nonmasked patients
Recovery of therapeutic recovery of ankle dorsiflexion weakness after surgical No validated outcome measures used
ankle decompression. Small sample size
dorsiflexion <80% follow-up
weakness Type of treatment(s): surgery Lacked subgroup analysis
following Diagnostic method not stated
lumbar Total number of patients: 56 Other:
decompressi Number of patients in relevant subgroup(s): 56
ve surgery. J
Clin Consecutively assigned? Yes Work group conclusions
Neurosci. Potential Level: IV
Aug Duration of follow-up: 24 months Downgraded Level:
2009;16(8):1
024-1027. Validated outcome measures used (list): Medical Conclusions relative to question
Research Council Scale (MRCS) This paper provides evidence that: timing of
surgery does not affect recovery of ankle
Nonvalidated outcome measures used (list): dorsiflexion.

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Ankle


dorsiflexion power at the long-term follow-up significantly
correlated with the preoperative ankle dorsiflexion power
(p < 0.001). Patients aged 25 to 40 years made a better
recovery in the first six weeks after surgery.

Author conclusions (relative to question): The duration of


ankle dorsiflexion weakness did not correlate with the
recovery from weakness.

McCarthy Level IV Prospective Retrospective Critique of methodology:


MJ, Aylott Nonconsecutive patients
CE, Grevitt Study design: case series Nonrandomized
MP, Hegarty Type of Nonmasked reviewers
J. Cauda evidence Stated objective of study: To determine the factors that Nonmasked patients
equina therapeutic influence outcome after surgery for cauda equina No validated outcome measures used
syndrome: syndrome. The primary aim of this study was to assess Small sample size
factors patient outcome following surgery for cauda equina <80% follow-up
affecting syndrome after a minimum of two years. Lacked subgroup analysis
long-term Diagnostic method not stated
functional Type of treatment(s): surgery Other: 42/54 patients attended follow-up
and (78%)
sphincteric Total number of patients: 56
outcome. Number of patients in relevant subgroup(s): 56
Spine (Phila Work group conclusions
Pa 1976). Consecutively assigned? Yes Potential Level: IV
Jan 15 Downgraded Level:
2007;32(2):2 Duration of follow-up: 60 months (range: 25114 months)
07-216. Conclusions relative to question
Validated outcome measures used (list): Back Outcome This paper provides evidence that:timing of
Score (LBOS), Modified Somatic Perception Score surgery does not affect outcome in cauda
(MSPQ), Modified Zung Depression Score (MZ), equina syndrome
International Prostate Severity Score (IPSS), Male Sexual
Health Inventory (MSHI)

Nonvalidated outcome measures used (list): Sheffield


Female Pelvic Floor Questionnaire (FPFQ).

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): There


are very little data regarding the 24- to 48-hour window.
Five (12%) of the cases were operated within 24 hours of
onset, 21 (50%) between 24 and 48 hours, and 16 (38%)
were after 48 hours. Of the latter group, three were due to
a delay in diagnosis. No significant difference was found in
outcome between the three groups. There may be a trend
toward improved sphincteric control if decompression is
performed within 48 hours. This was not significant after
Bonferroni correction and may indicate a Type 2 error.

Author conclusions (relative to question): the symptom


duration before operation and the speed of onset do not
affect the outcome more than two years after surgery.

Ng LC, Sell Level IV Prospective Retrospective Critique of methodology:


P. Predictive Nonconsecutive patients
value of the Study design: case series Nonrandomized
duration of Type of Nonmasked reviewers
sciatica for evidence Stated objective of study: to examine the association Nonmasked patients
lumbar therapeutic between the duration of sciatica and the outcome No validated outcome measures used
discectomy. of lumbar discectomy Small sample size
A <80% follow-up
prospective Type of treatment(s): discectomy Lacked subgroup analysis
cohort study. Diagnostic method not stated
J Bone Joint Total number of patients: 113 Other:
Surg Br. May Number of patients in relevant subgroup(s): 103
2004;86(4):5
46-549. Consecutively assigned? Yes Work group conclusions
Potential Level: IV
Duration of follow-up: one year Downgraded Level:

Validated outcome measures used (list): Oswestry Conclusions relative to question


Disability Index (ODI) score, the low back outcome score This paper provides evidence that:the
(LBOS), a visual analog duration of symptoms of sciatic pain (less
scale (VAS) than four months versus greater than 12
months) prior to surgery significantly and
Nonvalidated outcome measures used (list): patients negatively affected outcomes after lumbar
subjective evaluation of the surgery (excellent, good, fair discectomy.
or poor)

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: radiological

Results/subgroup analysis (relevant to question): The


duration of sciatica was related to the change in the ODI
score (p = 0.005) and the LBOS (p = 0.03). If the result
was expressed as a coefficient, an increase over one
month in the duration of symptoms was associated with a
reduction in the change of the ODI score of 0.6%. There
was also a weak negative correlation between the duration
of the sciatica and the change in the ODI score (Spearman
rank correlation coefficient, -0.2). No association was
found between the VAS score and the duration of sciatica
(p = 0.09).

Author conclusions (relative to question): patients with


sciatica for more than 12 months have a less favorable
outcome. No variation was detected in the results for
patients operated on in whom the duration of sciatica was
less than 12 months.

Nygaard OP, Level IV Prospective Retrospective Critique of methodology:


Kloster R, Nonconsecutive patients
Solberg T. Study design: case series Nonrandomized
Duration of Type of Nonmasked reviewers
leg pain as a evidence Stated objective of study: The aim of this study was to Nonmasked patients
predictor of therapeutic investigate different variables in the duration of symptoms No validated outcome measures used
outcome that can be used to Small sample size
after surgery predict outcome after lumbar microdiscectomy <80% follow-up
for lumbar Lacked subgroup analysis
disc Type of treatment(s): surgery Diagnostic method not stated
herniation: a Other:
prospective Total number of patients: 132
cohort study Number of patients in relevant subgroup(s): 132
with 1-year Work group conclusions
follow up. J Consecutively assigned? Yes Potential Level: IV
Neurosurg. Downgraded Level:
Apr Duration of follow-up: one year
2000;92(2 Conclusions relative to question
Suppl):131- Validated outcome measures used (list): ODI, VAS This paper provides evidence that: delaying
134. surgery for radiculopathy due to lumbar disc
. Nonvalidated outcome measures used (list): Clinical herniation for more than eight months was
Overall Score (COS) associated with poor outcomes.

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): In


patients in whom duration of leg pain was the shortest
(less than 4 months) a significantly lower COS was
demonstrated at the follow-up examination compared with
patients in whom duration of leg pain
was longer (> eight months)

Author conclusions (relative to question): the time for


surgical treatment of lumbar disc herniation may be two to
eight months. There are weak indications for surgery
before two months of sustained leg pain, and after eight
months the risk of a less favorable clinical result is
probably increased.

Olivero WC, Level IV Prospective Retrospective Critique of methodology:


Wang H, Nonconsecutive patients
Hanigan WC, Study design: case series Nonrandomized
et al. Cauda Type of Nonmasked reviewers
equina evidence Stated objective of study: determine the outcomes of Nonmasked patients
syndrome therapeutic patients with cauda equina syndrome from a herniated No validated outcome measures used
(CES) from lumbar disc Small sample size
lumbar disc <80% follow-up
herniations. J Type of treatment(s): decompression Lacked subgroup analysis
Spinal Disord Diagnostic method not stated
Tech. May Total number of patients: 31 Other:
2009;22(3):2 Number of patients in relevant subgroup(s): 31
02-206.
Consecutively assigned? Yes Work group conclusions
Potential Level: IV
Duration of follow-up: average of five years Downgraded Level:

Validated outcome measures used (list): Conclusions relative to question


This paper provides evidence that:there was
Nonvalidated outcome measures used (list): motor, no correlation between time-to-surgery and
sensory, urine catheter return of bladder, motor, or sensory function
after cauda equina syndrome.
Diagnosis made by:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Of the


27 patients available for follow-up, 25 (93%) regained
continence without urinary complaints. The only patient
performing intermittent catheterization at follow-up had
been operated on within 24 hours after onset of symptoms.
There was no statistically significant difference as far as
return of bladder function comparing patients operated on
less than 48 hours after onset of symptoms versus those
operated on after 48 hours (P<0.85). Long-term follow-up
was available for motor function in 29 patients. Eighty
percent of the patients regained normal motor function.
There was no difference between patients operated on
less than 48 hours versus those operated on greater than
48 hours after onset of symptoms (P<0.76). Long-term
sensory follow-up was available on 29 patients. Fifty
percent regained normal sensory function. No significant
difference was observed between the two time periods
(P<0.7).

Author conclusions (relative to question): Over 90%,


subjectively, regained normal bladder function. There was
no correlation between time-to-surgery and return of
bladder, motor, or sensory function. Unilateral exposure
was frequently all that was needed to adequately and
safely remove these large disc herniations. The authors
feel that the data support the practice of continuing to
operate on these patients as an emergency as soon as
they are diagnosed, unless there are medical or
anesthesia contradictions for emergency surgery.

Peul WC, Level III Prospective Retrospective Critique of methodology:


van Nonconsecutive patients
Houwelingen Study design: comparative Nonrandomized
HC, van den Type of Nonmasked reviewers
Hout WB, et evidence Stated objective of study: compares the efficacy of early Nonmasked patients
al. Surgery therapeutic surgical intervention with a strategy of prolonged No validated outcome measures used
versus conservative care Small sample size
prolonged <80% follow-up
conservative Type of treatment(s): early surgery, prolonged Lacked subgroup analysis
treatment for conservative measures Diagnostic method not stated
sciatica. N Other: Cross over: 11% in the early
Engl J Med. Total number of patients: 283 surgery group, 39% in the conservative
May 31 Number of patients in relevant subgroup(s): 283 group.
2007;356(22)
:2245-2256. Consecutively assigned? Yes
Work group conclusions
Duration of follow-up: 52 weeks Potential Level: II
Downgraded Level: III
Validated outcome measures used (list): Roland Morris
Disability Questionnaire, VAS Conclusions relative to question
This paper provides evidence that:early
Nonvalidated outcome measures used (list): surgery (6-12 weeks) for lumbar disc
herniation provides faster recovery and
Diagnosis made by: better pain relief than prolonged conservative
Clinical exam/history measures. There were no long-term outcome
Electromyography differences.
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): There


was no significant overall difference in disability scores
during the first year (p = 0.13). Relief of leg pain was faster
for patients assigned to early surgery (P<0.001). Patients
assigned to early surgery also reported a faster rate of
perceived recovery (hazard ratio, 1.97; 95% confidence
interval, 1.72 to 2.22; P<0.001). In both groups, however,
the probability of perceived recovery after one year of
follow-up was 95%.

Author conclusions (relative to question): The one-year


outcomes were similar for patients assigned to early
surgery and those assigned to conservative treatment with
eventual surgery if needed, but the rates of pain relief and
of perceived recovery were faster for those assigned to
early surgery.
Question #15:
Does discectomy (with or without preoperative medical/interventional treatment) result in better
outcomes (clinical or radiographic) than medical/interventional treatment for lumbar disc herniation?

Article Level
(Alpha by of Description of study Conclusion
Author) evidence

Buttermann Level II Prospective Retrospective Critique of methodology:


GR. Nonconsecutive patients
Treatment of Study design: RCT Nonrandomized
lumbar disc Type of Nonmasked reviewers
herniation: evidence Stated objective of study: compare microdiscectomy to Nonmasked patients
Epidural therapeutic epidural steroid injection in select population of patients with No validated outcome measures
steroid large lumbar disc herniations used
injection Small sample size
compared Type of treatment(s): epidural steroid injection, discectomy <80% follow-up
with Lacked subgroup analysis
discectomy - Total number of patients: 100 Diagnostic method not stated
A Number of patients in relevant subgroup(s): 50 in each group Other: The study was limited to a
prospective, select group with large sequestered
randomized Consecutively assigned? Yes fragments
study. J.
Bone Joint Duration of follow-up: three years
Surg.-Am. Work group conclusions
Vol. Apr Validated outcome measures used (list): Visual Analog Scale, Potential Level: II
2004;86A(4): Oswestry Disability Index Downgraded Level:
670-679.
Nonvalidated outcome measures used (list): satisfaction and Conclusions relative to question
success, as determined by patient questionnaires This paper provides evidence
that:patients with large disc herniations,
Diagnosis made by: occupying more than 25% of the spinal
Clinical exam/history canal, with symptoms which do not
Electromyography resolve in six weeks do better with
Myelogram surgery than epidural injections.
MRI However, about 50% of patients who
CT have injections will improve.
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): At one and


three months the surgically treated patients had a significant
increase in motor function compared to the patients treated
with epidural steroid injection. At two years the motor function
was not significantly different. The Oswestry Disability Index
and pain were similar at all time points. The surgical group
reported a statistically significant decrease in pain medication
usage at one and three months. The surgically treated group
expressed 92%-98% satisfaction versus 42%-56% for the
epidural steroid injection group. There were 27 patients that
failed epidural steroid injections and crossed over to the
surgical treatment group.

Author conclusions (relative to question): Epidural steroid


injection was not as effective as discectomy with regard to
reducing symptoms associated with a large herniation of the
lumbar disc.

Haines SJ, Level III Prospective Retrospective Critique of methodology:


Jordan N, Nonconsecutive patients
Boen JR, et Study design: RCT Nonrandomized
al. Type of Nonmasked reviewers
Discectomy evidence Stated objective of study: To compare the efficacy and cost Nonmasked patients
strategies for therapeutic effectiveness of automated percutaneous lumbar discectomy No validated outcome measures
lumbar disc (APLD) and conventional discectomy. used
herniation: Small sample size
results of the Type of treatment(s): automated percutaneous lumbar <80% follow-up
LAPDOG discectomy, conventional open discectomy Lacked subgroup analysis
trial. Journal Diagnostic method not stated
of clinical Total number of patients: 36 Other:
neuroscience Number of patients in relevant subgroup(s): 21 automated
: official percutaneous lumbar discectomy, 13 conventional discectomy
journal of the Work group conclusions
Neurosurgica Consecutively assigned? No Potential Level: II
l Society of Downgraded Level: III
Australasia. Duration of follow-up: one year
2002(4):411- Conclusions relative to question
417. Validated outcome measures used (list): Roland-Morris This paper provides evidence
http://www.m Disability Index, SF-36 that:There is no difference in efficacy or
rw.interscien cost effectiveness between automated
ce.wiley.com Nonvalidated outcome measures used (list): authors' own percutaneous lumbar discectomy and
/cochrane/clc matrix open discectomy. However, based on
entral/articles the small sample size, this study lacks
/869/CN- Diagnosis made by: statistical significance.
00409869/fra Clinical exam/history
me.html. Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: imaging

Results/subgroup analysis (relevant to question): At six


months, 41% of automated percutaneous lumbar discectomy
patients and 40% of conventional discectomy patients (total 27
patients) achieved successful outcomes.

Author conclusions (relative to question): The authors


concluded they had insufficient enrollment to draw conclusions.

Hermantin Level II Prospective Retrospective Critique of methodology:


FU, Peters T, Nonconsecutive patients
Quartararo L, Study design: RCT Nonrandomized
Kambin P. A Type of Nonmasked reviewers
prospective, evidence Stated objective of study: To evaluate the results of Nonmasked patients
randomized therapeutic arthroscopic percutaneous lumbar discectomy compared with No validated outcome measures
study open discectomy in patients with lumbar disc herniation and used
comparing radiculopathy. Small sample size
the results of <80% follow-up
open Type of treatment(s): video-assisted arthroscopic Lacked subgroup analysis
discectomy microdiscectomy, open discectomy Diagnostic method not stated
with those of Other: Randomization was limited to
video- Total number of patients: 60 select patients referred for an operative
assisted Number of patients in relevant subgroup(s): 30 arthroscopic procedure after non-standardized
arthroscopic discectomy; 30 open discectomy preoperative conservative care and only
microdiscect performed in patients who agreed to
omy. J Bone Consecutively assigned? No randomization.
Joint Surg
Am. Jul Duration of follow-up: average 30 months (range: 19-42
1999;81(7):9 months) Work group conclusions
58-965. Potential Level: I
Validated outcome measures used (list): none Downgraded Level: II

Nonvalidated outcome measures used (list): patient self Conclusions relative to question
evaluation, return to work This paper provides evidence that:in
select patients with lumbar disc
Diagnosis made by: herniation and radiculopathy, there is no
Clinical exam/history significant difference in outcome in
Electromyography patients treated with arthroscopic
Myelogram discectomy or open discectomy.
MRI Patients treated with open discectomy
CT may require longer narcotic use and
CT/Myelogram have a longer period of inability to work.
Other: imaging

Results/subgroup analysis (relevant to question): There was


no difference in outcomes between the groups (93%
satisfactory outcome in open discectomy, 97% in arthroscopic).
Return to work was mean 49 days in open patients and 27
days in arthroscopically-treated patients. Narcotic use was
longer (25 days vs seven days) in patients treated with open
discectomy.

Author conclusions (relative to question): In carefully selected


patients, arthroscopic percutaneous lumbar discectomy is a
useful treatment for lumbar disc herniation.

McMorland Level II Prospective Retrospective Critique of methodology:


G, Suter E, Nonconsecutive patients
Casha S, du Study design: RCT Nonrandomized
Plessis SJ, Type of Nonmasked reviewers
Hurlbert RJ. evidence Stated objective of study: To compare manipulation with Nonmasked patients
Manipulation therapeutic discectomy in patients with herniated nucleus pulposus with No validated outcome measures
or lumbar radiculopathy. used
microdiskect Small sample size
omy for Type of treatment(s): manipulation, discectomy <80% follow-up
sciatica? A Lacked subgroup analysis
prospective Total number of patients: 40 Diagnostic method not stated
randomized Number of patients in relevant subgroup(s): Twenty patients Other: There was significant
clinical study. were randomly assigned to manipulation and twenty were crossover and no "as treated" analysis.
J randomized to surgery.
Manipulative
Physiol Ther. Consecutively assigned? Yes Work group conclusions
Oct;33(8):57 Potential Level: I
6-584. Duration of follow-up: one year Downgraded Level: II

Validated outcome measures used (list): Roland-Morris Conclusions relative to question


Disability Index, SF-36, McGill Pain Questionnaire, Aberdeen This paper provides evidence that:short-
Back Pain Scale term outcomes in patients with lumbar
disc herniation with radiculopathy may
Nonvalidated outcome measures used (list): be superior in surgically treated patients
compared to patients treated with
Diagnosis made by: manipulation.
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:
Results/subgroup analysis (relevant to question): Sixty percent
of patients treated with manipulation and 85% of surgically
treated patients improved at 12 weeks. Eight patients who
crossed over to surgery had improvement comparable to those
treated initially with surgery. There was no difference in intent
to treat analysis at one year.

Author conclusions (relative to question): Sixty percent of


medically managed patients (manipulation) responded as well
to treatment as surgically treated patients at 12 weeks.

Osterman H, Level III Prospective Retrospective Critique of methodology:


Seitsalo S, Nonconsecutive patients
Karppinen J, Study design: RCT Nonrandomized
Malmivaara Type of Nonmasked reviewers
A. evidence Stated objective of study: To assess outcomes of Nonmasked patients
Effectiveness therapeutic microdiscectomy compared to conservative treatment for No validated outcome measures
of lumbar disc herniation in patients with six to 12 weeks of used
microdiscect symptoms. Small sample size
omy for <80% follow-up
lumbar disc Type of treatment(s): microdiscectomy, conservative care Lacked subgroup analysis
herniation - A Diagnostic method not stated
randomized Total number of patients: 56 Other:
controlled Number of patients in relevant subgroup(s): 28 in each group
trial with 2
years of Consecutively assigned? Yes Work group conclusions
follow-up. Potential Level: II
Spine. Oct Duration of follow-up: up to two years Downgraded Level: III
2006;31(21):
2409-2414. Validated outcome measures used (list): Oswestry Disability Conclusions relative to question
Index, Visual Analog Scale This paper provides evidence
that:patients treated with surgery have
Nonvalidated outcome measures used (list): faster and more complete recovery of
back and leg pain. Results are better
Diagnosis made by: for surgical group at all time points and
Clinical exam/history for all measures out to two years. The
Electromyography authors note that statistical significance
Myelogram is lost after three months, however, 11
MRI of the 28 medical/interventional patients
CT had surgery (resulting in a 40%
CT/Myelogram crossover), most of which happened
Other: after three months.

Results/subgroup analysis (relevant to question): There were


no clinically significant differences between the groups at two
year follow-up. Discectomy was associated with a more rapid
recovery.

Author conclusions (relative to question): Lumbar


microdiscectomy provided only modest short-term benefit over
conservative treatment.

Thomas KC, Level III Prospective Retrospective Critique of methodology:


Fisher CG, Nonconsecutive patients
Boyd M, Study design: comparative Nonrandomized
Bishop P, Type of Nonmasked reviewers
Wing P, evidence Stated objective of study: To compare operative and Nonmasked patients
Dvorak MF. therapeutic nonoperative management of lumbar disc herniation. No validated outcome measures
Outcome used
evaluation of Type of treatment(s): operative versus "usual care" (injection- Small sample size
surgical and based therapy excluded) <80% follow-up
nonsurgical Lacked subgroup analysis
management Total number of patients: 497 Diagnostic method not stated
of lumbar Number of patients in relevant subgroup(s): 333/164 Other: The study shows significant
disc differences in populations of cohorts
protrusion Consecutively assigned? No regarding previous surgery, degree of
causing disability, level of education, etc.
radiculopathy Duration of follow-up: two years
. Spine (Phila
Pa 1976). Validated outcome measures used (list): North American Work group conclusions
Jun 1 Spine Society Lumbar Spine Follow-Up Questionnaire, Version Potential Level: II
2007;32(13): 2.0; SF-36 Downgraded Level: III
1414-1422.
Nonvalidated outcome measures used (list): Conclusions relative to question
This paper provides evidence
Diagnosis made by: that:Patients who choose surgery tend
Clinical exam/history to have greater degrees of disability and
Electromyography pain than those who choose not to have
Myelogram surgery. Patients who choose surgery
MRI have a statistically significant and
CT durable improvement in pain and health
CT/Myelogram quality, while functional outcome is
Other: similar between the two groups.

Results/subgroup analysis (relevant to


question): Improvement in HRQOL outcomes was the same in
both medical and surgical patients, but improvement did not
achieve normative population scores.

Author conclusions (relative to question): Medical and surgical


management produce similar outcomes.

van Alphen Level III Prospective Retrospective Critique of methodology:


HA, Nonconsecutive patients
Braakman R, Study design: RCT Nonrandomized
Berfelo MW, Type of Nonmasked reviewers
Broere G, evidence Stated objective of study: To compare chymopapain and Nonmasked patients
Bezemer PD, therapeutic surgery in the treatment of one level disc herniation which No validated outcome measures
Kostense PJ. failed surgery. used
Chemonucle Small sample size
olysis or Type of treatment(s): microdiscectomy versus chymopapain <80% follow-up
discectomy? Lacked subgroup analysis
Results of a Total number of patients: 151 Diagnostic method not stated
randomized Number of patients in relevant subgroup(s): 78 discectomy, 73 Other: The outcome measures,
multicentre chemonucleolysis except for reoperation, were not
trial in validated
patients with Consecutively assigned? Yes
a herniated
lumbar Duration of follow-up: one year Work group conclusions
intervertebral Potential Level: II
disc (a Validated outcome measures used (list): reoperation rate Downgraded Level: III
preliminary
report). Acta Nonvalidated outcome measures used (list): subjective Conclusions relative to question
neurochirurgi outcomes scale from doctors and patients This paper provides evidence that:
ca. microdiscectomy is associated with
Supplementu Diagnosis made by: better outcomes than chymopapain.
m. 1988:35- Clinical exam/history
38. Electromyography
http://www.m Myelogram
rw.interscien MRI
ce.wiley.com CT
/cochrane/clc CT/Myelogram
entral/articles Other: not well described
/442/CN-
00057442/fra
me.html. Results/subgroup analysis (relevant to
question): Microdiscectomy was better than chymopapain due
to the 25% reoperation rate after chymopapain compared to
3% for surgery. There was better patient and doctor reported
outcomes following microdiscectomy (25% crossover from
chemonucleolysis to surgery group within one year). After
crossover, the overall success rate in an intent to treat analysis
showed 73% success with chemonucleolysis and 78% with
surgery.

Author conclusions (relative to question): Chemonucleolysis is


an option in patients who failed conservative treatment.

Weinstein Level II Prospective Retrospective Critique of methodology:


JN, Lurie JD, Nonconsecutive patients
Tosteson Study design: comparative Nonrandomized
TD, et al. Type of Nonmasked reviewers
Surgical vs evidence Stated objective of study: To evaluate surgery versus Nonmasked patients
nonoperative therapeutic medical/interventional treatment of lumbar intervertebral disc No validated outcome measures
treatment for herniation. used
lumbar disk Small sample size
herniation: Type of treatment(s): Lumbar discectomy, <80% follow-up
the Spine medical/interventional treatment tailored to the patient. Lacked subgroup analysis
Patient Diagnostic method not stated
Outcomes Total number of patients: 743 Other:
Research Number of patients in relevant subgroup(s): The surgically
Trial treated group consisted of 528 patients and the
(SPORT) medical/interventional group consisted of 191 patients. Work group conclusions
observational Potential Level: II
cohort. Consecutively assigned? No Downgraded Level:
JAMA. Nov
22 Duration of follow-up: two years Conclusions relative to question
2006;296(20) This paper provides evidence that:at up
:2451-2459. Validated outcome measures used (list): SF-36, Oswestry to two years, patients whose symptoms
Disability Index are severe enough to warrant surgery
enjoy substantial benefits compared to
Nonvalidated outcome measures used (list): patient self medical/interventional patients.
reported improvement, work status and satisfaction

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): At three


months, patients in the surgical group had statistically
significant improvement in measures of bodily pain, physical
function and Oswestry Disability Index which narrowed at two
years but remained statistically significant.

Author conclusions (relative to question): Patients with


persistent sciatica from lumbar disc herniation improved in both
surgical and medical/interventional treatment groups.

Weinstein Level II Prospective Retrospective Critique of methodology:


JN, Tosteson Nonconsecutive patients
TD, Lurie JD, Study design: RCT Nonrandomized
et al. Type of Nonmasked reviewers
Surgical vs evidence Stated objective of study: To assess the efficacy of surgery for Nonmasked patients
nonoperative therapeutic lumbar intervertebral disc herniation. No validated outcome measures
treatment for used
lumbar disk Type of treatment(s): microdiscectomy, medical/interventional Small sample size
herniation: treatment <80% follow-up
the Spine Lacked subgroup analysis
Patient Total number of patients: 1244 Diagnostic method not stated
Outcomes Number of patients in relevant subgroup(s): There were 232 Other: crossover killed
Research patients treated surgically and 240 patients treated randomization, became a cohort study
Trial medically/interventionally
(SPORT): a
randomized Consecutively assigned? No Work group conclusions
trial. JAMA. Potential Level: I
Nov 22 Duration of follow-up: two years Downgraded Level: II
2006;296(20)
:2441-2450. Validated outcome measures used (list): SF-36, Oswestry Conclusions relative to question
Disability Index This paper provides evidence that:at up
to two years, patients whose symptoms
Nonvalidated outcome measures used (list): patient self are severe enough to warrant surgery
reported improvement, work status and satisfaction enjoy substantial benefits compared to
medical/interventional patients.
Diagnosis made by:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:
Results/subgroup analysis (relevant to question): There was
30% crossover from the medical/interventional group to the
surgical group. At three months, one year and two years the
treatment effect in the intent to treat analysis favored surgery.

Author conclusions (relative to question): Patients in both


groups improved over the two year period. Because of the
large numbers of crossover patients, conclusions about the
superiority or equivalence of treatments are not warranted
based on the intent to treat analysis.

Weinstein Level II Prospective Retrospective Critique of methodology:


JN, Lurie JD, Nonconsecutive patients
Tosteson Study design: RCT Nonrandomized
TD, et al. Type of Nonmasked reviewers
Surgical evidence Stated objective of study: To assess the efficacy of surgery for Nonmasked patients
versus therapeutic lumbar intervertebral disc herniation No validated outcome measures
nonoperative used
treatment for Type of treatment(s): microdiscectomy, medical/interventional Small sample size
lumbar disc treatment <80% follow-up
herniation: Lacked subgroup analysis
four-year Total number of patients: 1244 Diagnostic method not stated
results for Number of patients in relevant subgroup(s): In the randomized Other: crossover killed
the Spine group there were 245 surgically treated patients and 256 randomization, became a cohort study
Patient medical/interventional patients. In the observational cohort 521
Outcomes patients were treated surgically and 222 patients were treated
Research medically/interventionally. Work group conclusions
Trial Potential Level: I
(SPORT). Consecutively assigned? No Downgraded Level: II
Spine (Phila
Pa 1976). Duration of follow-up: four years Conclusions relative to question
Dec 1 This paper provides evidence that:at up
2008;33(25): Validated outcome measures used (list): SF-36, Oswestry to four years, patients whose symptoms
2789-2800. Disability Index are severe enough to warrant surgery
enjoy substantial benefits compared to
Nonvalidated outcome measures used (list): patient self medical/interventional patients.
reported improvement, work status and satisfaction
Diagnosis made by:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): There was


30% crossover from the medical/interventional treatment group
to the surgical group. At three months, one year, two years and
four years the treatment effect in the combined as treated
analysis favors surgery.

Author conclusions (relative to question): Patients in both


groups improved over the four year period. Because of the
large numbers of crossover patients, conclusions about the
superiority or equivalence of treatments are not warranted
based on the intent to treat analysis
Question #16:
Are there clinical circumstances in which lumbar fusion is appropriate in the treatment of lumbar disc
herniation?

Article Level
(Alpha by of Description of study Conclusion
Author) evidence

Eie N: Level IV Prospective Retrospective Critique of methodology:


Comparison Nonconsecutive patients
of the results Study design: comparative Nonrandomized
in patients Type of Nonmasked reviewers
operated evidence Stated objective of study: compare results of fusion and Nonmasked patients
upon for therapeutic discectomy in the treatment of lumbar disc herniation No validated outcome measures used
ruptured Small sample size
lumbar discs Type of treatment(s): discectomy with and without fusion <80% follow-up
with and Lacked subgroup analysis
without Total number of patients: 259 Diagnostic method not stated
spinal Number of patients in relevant subgroup(s): 191 Other:
fusion. Acta discectomy; 68 fusion
Neurochir
41:107113, Consecutively assigned? Yes Work group conclusions
1978. Potential Level: III
Duration of follow-up: 6-7 years Downgraded Level: IV

Validated outcome measures used (list): none Conclusions relative to question


This paper provides evidence that:long-term
Nonvalidated outcome measures used (list): satisfactory, outcomes may be improved with fusion.
partial, none

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): At six


month follow-up, there was statistically less recurrence of
pain in the fusion group. The main source of pain in the
discectomy group was recurrent herniations and
pseudoarthrosis in the fusion group. At final follow-up the
results were slightly better in the fusion group, but the
differences were not statistically significant. No statistical
difference was found in return work.

Author conclusions (relative to question): fusion is


recommended for young patients and discectomy for older
patients.

Donceel P, Level IV Prospective Retrospective Critique of methodology:


Du Bois M: Nonconsecutive patients
Fitness for Study design: comparative Nonrandomized
work after Type of Nonmasked reviewers
surgery for evidence Stated objective of study: compare fitness for work after Nonmasked patients
lumbar disc therapeutic surgery for discectomy, percutaneous discectomy, and No validated outcome measures used
herniation: a fusion Small sample size
retrospective <80% follow-up
study. Eur Type of treatment(s): discectomy, percutaneous Lacked subgroup analysis
Spine J discectomy, and fusion Diagnostic method not stated
7:2935, Other: functional groups not equal to start
1998 Total number of patients: 3956 with
Number of patients in relevant subgroup(s): 3544 standard
discectomy, 126 percutaneous discectomy, 286 fusion
Work group conclusions
Consecutively assigned? Yes Potential Level: III
Downgraded Level: IV
Duration of follow-up: 1-3 years
Conclusions relative to question
Validated outcome measures used (list): none This paper provides evidence
that:discectomy with fusion is associated with
Nonvalidated outcome measures used (list): fitness to work a poor outcome compared to discectomy
as determined by health care provider in the first six months alone in the treatment of lumbar disc
to return to their own work and after six months to any job herniation with radiculopathy.

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: search database

Results/subgroup analysis (relevant to


question): Discectomy combined with fusion was
significantly related to poor outcomes, whereas standard
discectomy and percutaneous nucleotomy did not differ in
their impact on fitness for work.

Author conclusions (relative to question): no


recommendations regarding which procedure is performed

Matsunaga Level IV Prospective Retrospective Critique of methodology:


S, Sakou T, Nonconsecutive patients
Taketomi E, Study design: comparative Nonrandomized
et al: Type of Nonmasked reviewers
Comparison evidence Stated objective of study: compare results of percutaneous Nonmasked patients
of operative therapeutic discectomy, discectomy, and fusion for patients with simple No validated outcome measures used
results of disc herniations who are manual laborers and athletes Small sample size
lumbar disc <80% follow-up
herniation in Type of treatment(s): percutaneous discectomy, Lacked subgroup analysis
manual discectomy, and fusion Diagnostic method not stated
laborers and Other: groups substantially different
athletes. Spi Total number of patients: 82 manual laborers and 28
ne 18:2222 athletes
2226, 1993 Number of patients in relevant subgroup(s): 30 discectomy, Work group conclusions
51 percutaneous discectomy, 29 fusion Potential Level: III
Downgraded Level: IV
Consecutively assigned? Yes
Conclusions relative to question
Duration of follow-up: varied from two years and nine This paper provides evidence that:simple
months to seven years and three months; percutanous discectomy is associated with earlier return
group had the shortest follow-up and simple discectomy to work and competitive sports, however,
and fusion were not too different long-term back pain is improved with fusion
in manual laborers.
Validated outcome measures used (list): no

Nonvalidated outcome measures used (list): return to work,


time to return to work, factors that prevented return to work

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: not stated

Results/subgroup analysis (relevant to question): Only two


patients in the athlete group had fusions. For manual
laborers there was a higher return to work with a fusion as
opposed to discectomy. Time of return to work was shorter
in the discectomy group than the fusion group. Lumbar
fatigue was the main reason why people didnt return to
work and that was more commonly found in the simple
discectomy patients.

Author conclusions (relative to question): manual laborers


should undergo fusion for disc herniations to provide the
best chance of return to work.

Takeshima Level III Prospective Retrospective Critique of methodology:


T, Kambara Nonconsecutive patients
K, Miyata S, Study design: comparative Nonrandomized
et al: Clinical Type of Nonmasked reviewers
and evidence Stated objective of study: to compare the clinical and Nonmasked patients
radiographic therapeutic radiographic results of simple disc excision and No validated outcome measures used
evaluation of posterolateral fusion in lumbar disc herniation patients. Small sample size
disc excision <80% follow-up
for lumbar Type of treatment(s): disc excision with and without Lacked subgroup analysis
disc posterolateral fusion Diagnostic method not stated
herniation Other:
with and Total number of patients: 95
without Number of patients in relevant subgroup(s): 44 discectomy;
posterolatera 51 fusion Work group conclusions
l Potential Level: II
fusion. Spine Consecutively assigned? Yes Downgraded Level: III
25:450456,
2000 Duration of follow-up: 6.6 (+/- 2.1) years in the nonfusion Conclusions relative to question
group; 7.4 (+/- 1.8) years in the fusion group This paper provides evidence that:primary
fusion is rarely indicated.
Validated outcome measures used (list): Japanese
Orthopedic Association (JOA) Score

Nonvalidated outcome measures used (list): measurement


of disc height

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:
Results/subgroup analysis (relevant to question): Although
better results were seen in JOA for the fusion group, this
was not statistically significant. Postoperative low back pain
was statistically greater in the fusion group when JOA
scores were evaluated. When asked, less patients with
fusion had low back pain than discectomy. More patients
had recurrent disc herniations in the non-fusion group.
Fusion was longer surgery with more blood loss and longer
hospital stay. There was statistically more loss of disc
height at five years in the nonfusion group, and statistically
less motion in the fusion group.

Author conclusions (relative to question): there is seldom


an indication for primary fusion for lumbar disc herniation.
Question #17:
Is there a difference in outcome (clinical or radiographic) or complications between different surgical
approaches in the treatment of a lumbar disc herniation?

Article Level
(Alpha by of Description of study Conclusion
Author) evidence

Abramovitz Level III Prospective Retrospective Critique of methodology:


JN, Neff SR. Nonconsecutive patients
Lumbar disc Study design: comparative Nonrandomized
surgery: Type of Nonmasked reviewers
results of the evidence Stated objective of study: evaluate the indications and efficacy Nonmasked patients
Prospective therapeutic of lumbar discectomy No validated outcome measures used
Lumbar Small sample size
Discectomy Type of treatment(s): lumbar discectomy, with or without <80% follow-up
Study of the microscope, with or without facetectomy Lacked subgroup analysis
Joint Section Diagnostic method not stated
on Disorders Total number of patients: 740 Other: diagnostic criteria not provided
of the Spine Number of patients in relevant subgroup(s): unknown
and
Peripheral Consecutively assigned? Yes Work group conclusions
Nerves of the Potential Level: II
American Duration of follow-up: 12 months (but three month data fully Downgraded Level: III
Association analyzed in 533 patients.
of Conclusions relative to question
Neurological Validated outcome measures used (list): none This paper provides evidence
Surgeons that:facetectomy for lumbar disc disease is
and the Nonvalidated outcome measures used (list): poor - good associated with increased risk of
Congress of defined by study postoperative back pain in comparison to
Neurological patients treated without facetectomy.
Surgeons. Diagnosis made by:
Neurosurger Clinical exam/history
y. Aug Electromyography
1991;29(2):3 Myelogram
01-307; MRI
discussion CT
307-308. CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Facetectomy


resulted in a 5.8 times greater risk of a "nonradicular" failure.
Use of the operating microscope improved outcome in patients
with 1-2 predictors of favorable outcome but worsened
outcome in patients with 5-6 predictors.

Author conclusions (relative to question): Meaning of these


findings (re: microscope) are speculative.

Arts MP, Level I Prospective Retrospective Critique of methodology:


Brand R, van Nonconsecutive patients
den Akker Study design: RCT Nonrandomized
ME, et al. Type of Nonmasked reviewers
Tubular evidence Stated objective of study: evaluate tubular versus open Nonmasked patients
diskectomy therapeutic microdiscectomy No validated outcome measures used
vs Small sample size
conventional Type of treatment(s): tubular discectomy, microdiscectomy <80% follow-up
microdiskect Lacked subgroup analysis
omy for Total number of patients: 328 Diagnostic method not stated
sciatica: a Number of patients in relevant subgroup(s): 167 tubular Other:
randomized discectomy, 161 conventional microdiscectomy
controlled
trial. JAMA. Consecutively assigned? Yes Work group conclusions
Jul 8 Potential Level: I
2009;302(2): Duration of follow-up: one year Downgraded Level:
149-158.
Validated outcome measures used (list): Roland Morris Conclusions relative to question
Disability Questionnaire, Visual Analog Scale, Likert This paper provides evidence
satisfaction that:Conventional microdiscectomy
produces similar results to tubular
Nonvalidated outcome measures used (list): discectomy in functional outcome as
assessed by the Roland Morris Disability
Diagnosis made by: score. Recovery rate and improvement in
Clinical exam/history back and leg pain was superior in patients
Electromyography treated with conventional microdiscectomy
Myelogram with no differences in hospital stay or
MRI blood loss.
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): During the


entire follow up period, no statistical difference was found in
the Roland Morris Disability scores between the two surgical
treatment groups. Visual Analog Scores for back and leg pain
were statistically superior in the patients treated with
conventional microdiscectomy.

Author conclusions (relative to question): The expected


treatment benefit of faster recovery after tubular discectomy
could not be demonstrated in this study. Pain and recovery
rates were superior in the patients treated with conventional
microdiscectomy.

Barth M, Level III Prospective Retrospective Critique of methodology:


Diepers M, Nonconsecutive patients
Weiss C, Study design: comparative Nonrandomized
Thome C. Type of Nonmasked reviewers
Two-year evidence Stated objective of study: Assess and compare disc Nonmasked patients
outcome therapeutic morphology 2 years after surgery in patients randomized to No validated outcome measures used
after lumbar either discectomy or sequestrectomy . Small sample size
microdiscect <80% follow-up
omy versus Type of treatment(s): microscopic discectomy; microscopic Lacked subgroup analysis
microscopic sequestrectomy Diagnostic method not stated
sequestrecto Other: Postoperative MR studies not
my: part 2: Total number of patients: 84 available in all randomized patients
radiographic Number of patients in relevant subgroup(s): 19 preoperative
evaluation and 32 postoperative MRs in discectomy patients; 29
and preoperative and 34 postoperative MRs in sequestrectomy Work group conclusions
correlation patients Potential Level: II
with clinical Downgraded Level: III
outcome. Consecutively assigned? No
Spine (Phila Conclusions relative to question
Pa 1976). Duration of follow-up: 18-29 months This paper provides evidence
Feb 1 that:sequestrectomy produces significantly
2008;33(3):2 Validated outcome measures used (list): none less postoperative disc degeneration than
73-279. discectomy in patients with lumbar disc
Nonvalidated outcome measures used (list): author defined herniation and radiculopathy.
disc findings, Modic changes, disc height Postoperative disc degeneration (endplate
changes) correlates significantly with low
Diagnosis made by: back pain.
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): No


significant difference in relevant disc protrusions or extrusions
in discectomy (66%) or sequestrectomy (68%) patients. The
presence of an extrusion or protrusion didn't correlate with
symptoms. Loss of disc height was significantly more common
in discectomy patients (63% vs. 38%, p <0.05). Endplate
degeneration was significantly more common in discectomy
patients (47% vs 14% p< 0.01). A significant correlation was
present between endplate change and low back pain.

Author conclusions (relative to question): Sequestrectomy


demonstrated significantly less postoperative disc
degeneration than microdiscectomy after two years.
Barth M, Level II Prospective Retrospective Critique of methodology:
Weiss C, Nonconsecutive patients
Thome C. Study design: comparative Nonrandomized
Two-year Type of Nonmasked reviewers
outcome evidence Stated objective of study: Compare microdiscectomy with Nonmasked patients
after lumbar therapeutic sequestrectomy in patients with lumbar disc herniation and No validated outcome measures used
microdiscect radiculopathy. Small sample size
omy versus <80% follow-up
microscopic Type of treatment(s): microscopic discectomy; microscopic Lacked subgroup analysis
sequestrecto sequestrectomy Diagnostic method not stated
my: part 1: Other:
evaluation of Total number of patients: 84
clinical Number of patients in relevant subgroup(s): 38 -
outcome. microdiscectomy, 40 - sequestrectomy Work group conclusions
Spine (Phila Potential Level: II
Pa 1976). Consecutively assigned? No Downgraded Level:
Feb 1
2008;33(3):2 Duration of follow-up: two years Conclusions relative to question
65-272. This paper provides evidence that:there is
Validated outcome measures used (list): SF 36, VAS no significant difference in reherniation
rates after microdiscectomy or
Nonvalidated outcome measures used (list): reherniation rate, sequestrectomy but that long term
self rated sensory and motor deficit, impairment in activity of functional outcome after sequestrectomy
daily living, impairment is superior. Outcome after
microdiscectomy worsens with time.
Diagnosis made by:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Reherniation


rates did not differ significantly (discectomy - 12.5%,
sequestrectomy - 12.5%). Self rated assessment deteriorated
over time (2 years) in discectomy patients but improved in
sequestrectomy patients. Sequestrectomy was superior in
physical and social functioning, use of analgesics, and overall
outcome at two years

Author conclusions (relative to question): Reherniation rates


and parameters of clinical investigation were similar two years
after microdiscectomy or sequestrectomy. However,
sequestrectomy was associated with a better functional
outcome over time.

Debi R, Level I Prospective Retrospective Critique of methodology:


Halperin N, Nonconsecutive patients
Mirovsky Y. Study design: RCT Nonrandomized
Local Type of Nonmasked reviewers
application of evidence Stated objective of study: Evaluate the efficacy of topical Nonmasked patients
steroids therapeutic steroid application to reduce pain following lumbar discectomy No validated outcome measures used
following Small sample size
lumbar Type of treatment(s): Application of either methylprednisolone <80% follow-up
discectomy. or saline collagen sponge to the decompressed nerve root Lacked subgroup analysis
J Spinal Diagnostic method not stated
Disord Tech. Total number of patients: 70 Other:
Aug Number of patients in relevant subgroup(s): 26 -
2002;15(4):2 methylprednisolone, 35 - saline
73-276. Work group conclusions
Consecutively assigned? Yes Potential Level: I
Downgraded Level:
Duration of follow-up: one year
Conclusions relative to question
Validated outcome measures used (list): VAS pain This paper provides evidence
that:Application of steroids versus saline
Nonvalidated outcome measures used (list): on a collagen sponge to the
decompressed nerve root resulted in
Diagnosis made by: short-term (14 day) improvement in back
Clinical exam/history pain but not leg pain which may not be
Electromyography clinically relevant. There was no effect at
Myelogram one year.
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Application


of the methylprednisolone sponge produces statistically
superior pain reduction compared to the saline soaked sponge
in the immediate postoperative period but no difference was
found at one year.

Author conclusions (relative to question): Local application of


steroid to the decompressed nerve root produced short-term
benefit but no long-term effect.

Epstein NE. Level IV Prospective Retrospective Critique of methodology:


Evaluation of Nonconsecutive patients
varied Study design: comparative Nonrandomized
surgical Type of Nonmasked reviewers
approaches evidence Stated objective of study: determine and compare indications Nonmasked patients
used in the therapeutic and benefits of varying surgical approaches to far lateral No validated outcome measures used
management lumbar disc herniation Small sample size
of 170 far- <80% follow-up
lateral Type of treatment(s): complete facetectomy, laminotomy with Lacked subgroup analysis
lumbar disc medial facetectomy, intertransverse discectomy Diagnostic method not stated
herniations: Other: Significant comorbid pathology in
indications Total number of patients: 174 addition to disc herniation
and results. J Number of patients in relevant subgroup(s): 73- complete
Neurosurg. facetectomy, 39- laminotomy with medial facetectomy, 58 -
Oct intertransverse discectomy Work group conclusions
1995;83(4):6 Potential Level: III
48-656. Consecutively assigned? Yes Downgraded Level: IV

Duration of follow-up: five years (0.5 - 10 years) Conclusions relative to question


This paper provides evidence that:In
Validated outcome measures used (list): no patients with far lateral disc herniations,
differing surgical approaches produced
Nonvalidated outcome measures used (list): authors own similar outcomes.
criteria (poor - excellent)

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): No


difference in outcomes (% with good-excellent result) was seen
between the surgical treatment subgroups.

Author conclusions (relative to question): The three surgical


procedures yielded near comparable outcomes in patients with
far lateral disc herniations.

Gambardella Level III Prospective Retrospective Critique of methodology:


G, Gervasio Nonconsecutive patients
O, Zaccone Study design: RCT Nonrandomized
C, Puglisi E. Type of Nonmasked reviewers
Prevention of evidence Stated objective of study: Evaluate the effect of an adipose Nonmasked patients
recurrent therapeutic tissue graft on postoperative scarring and clinical outcomes No validated outcome measures used
radicular Small sample size
pain after Type of treatment(s): Application of an adipose tissue graft, <80% follow-up
lumbar disc controls Lacked subgroup analysis
surgery: a Diagnostic method not stated
prospective Total number of patients: 74 Other:
study. Acta Number of patients in relevant subgroup(s): 37 - adipose graft,
Neurochir 37 - controls (no graft)
Suppl. Work group conclusions
2005;92:151- Consecutively assigned? No Potential Level: II
154. Downgraded Level: III
Duration of follow-up: one year
Conclusions relative to question
Validated outcome measures used (list): none This paper provides evidence that:Placing
a fat graft may reduce epidural fibrosis and
Nonvalidated outcome measures used (list): Author's own improve clinical outcome in patients
postoperative symptoms score and postoperative fibrosis score undergoing lumbar discectomy.

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Clinical and


radiologic outcomes were superior in patients treated with the
adipose graft.

Author conclusions (relative to question): Adipose tissue


autograft has a positive effect in preventing postoperative
scarring and failed back syndrome.

Henriksen L, Level II Prospective Retrospective Critique of methodology:


Schmidt K, Nonconsecutive patients
Eskesen V, Study design: RCT Nonrandomized
Jantzen E. A Type of Nonmasked reviewers
controlled evidence Stated objective of study: Evaluate whether microdiscectomy Nonmasked patients
study of therapeutic compared with standard discectomy would reduce the length of No validated outcome measures used
microsurgical stay or postoperative morbidity in patients with lumbar disc Small sample size
versus herniation. <80% follow-up
standard Lacked subgroup analysis
lumbar Type of treatment(s): Microdiscectomy, standard discectomy Diagnostic method not stated
discectomy. Other:
Br J Total number of patients: 79
Neurosurg. Number of patients in relevant subgroup(s): microdiscectomy -
Jun 40, standard discectomy - 39 Work group conclusions
1996;10(3):2 Potential Level: I
89-293. Consecutively assigned? Yes Downgraded Level: II

Duration of follow-up: six weeks Conclusions relative to question


This paper provides evidence
Validated outcome measures used (list): Visual Analog Scale that:outcomes are similar between
microdiscectomy and standard discectomy
Nonvalidated outcome measures used (list): length of stay in patients with lumbar disc herniation

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): No


difference was seen in VAS at any time between the two
treatments. Operative time was longer in the microdiscectomy
patients (48 minutes versus 35 minutes, p<.0001). There was
no difference in length of stay (5.2 days for microdiscectomy,
4.6 days for standard discectomy).

Author conclusions (relative to question): Microdiscectomy


does not shorten length of stay or influence postoperative
morbidity.

Jensen TT, Level I Prospective Retrospective Critique of methodology:


Asmussen K, Nonconsecutive patients
Berg-Hansen Study design: RCT Nonrandomized
EM, et al. Type of Nonmasked reviewers
First-time evidence Stated objective of study: Evaluate whether a free fat graft at Nonmasked patients
operation for therapeutic the time of open lumbar discectomy affects clinical outcome or No validated outcome measures used
lumbar disc scar formation. Small sample size
herniation <80% follow-up
with or Type of treatment(s): open discectomy plus or minus fat graft Lacked subgroup analysis
without free Diagnostic method not stated
fat Total number of patients: 99 Other:
transplantati Number of patients in relevant subgroup(s): 50 - free fat graft,
on. 49 - no fat graft
Prospective Work group conclusions
triple-blind Consecutively assigned? Yes Potential Level: I
randomized Downgraded Level:
study with Duration of follow-up: 376 days (276-501 days)
reference to Conclusions relative to question
clinical Validated outcome measures used (list): Low back pain rating This paper provides evidence that:adding
factors and scale a fat graft following open discectomy does
enhanced not improve clinical outcome.
computed Nonvalidated outcome measures used (list): CT assessment of
tomographic scar and fat graft postoperatively, patient global self
scan 1 year assessment
after
operation. Diagnosis made by:
Spine. Clinical exam/history
1996(9):1072 Electromyography
-1076. Myelogram
http://www.m MRI
rw.interscien CT
ce.wiley.com CT/Myelogram
/cochrane/clc Other:
entral/articles
/719/CN-
00127719/fra Results/subgroup analysis (relevant to question): No
me.html. differences were found in clinical outcomes between the two
groups. Patients treated with fat graft had less dural scar but
no difference in radicular scarring. Fat graft was visible in 66%
of patients.
Author conclusions (relative to question): Free fat graft can
reduce the degree of dural scarring, but doesn't result in an
improved clinical outcome.

Kim KD, Level III Prospective Retrospective Critique of methodology:


Wang JC, Nonconsecutive patients
Robertson Study design: RCT Nonrandomized
DP, et al. Type of Nonmasked reviewers
Reduction of evidence Stated objective of study: Compare the outcomes of Nonmasked patients
leg pain and therapeutic discectomy with Oxiplex gel with discectomy without gel. No validated outcome measures used
lower- Small sample size
extremity Type of treatment(s): discectomy, discectomy plus Oxiplex/SP <80% follow-up
weakness for Lacked subgroup analysis
1 year with Total number of patients: 18 total Diagnostic method not stated
Oxiplex/SP Number of patients in relevant subgroup(s): 11 discectomy Other: 50% loss to follow-up
gel following plus Oxiplex/SP; 7 discectomy
laminectomy,
laminotomy, Consecutively assigned? No Work group conclusions
and Potential Level: II
discectomy. Duration of follow-up: 12 months Downgraded Level: III
Neurosurg
Focus. Jul 15 Validated outcome measures used (list): Lumbar Spine Conclusions relative to question
2004;17(1):E Outcome Questionnaire This paper provides evidence that:
CP1. Because of the 50% loss to follow-up, it is
Nonvalidated outcome measures used (list): leg pain, physical impossible to draw any conclusions from
symptoms and function self assessment scores, MR this paper.
postoperative assessment of scar

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:
Results/subgroup analysis (relevant to question): Gel treated
patients has less leg pain symptoms (p < 0.038) and weakness
(p < 0.023) than non-gel treated patients. No difference in MR
appearance was found.

Author conclusions (relative to question): Gel treated patients


had superior clinical outcomes to controls which was
maintained over the one year study.

Kim KD, Level II Prospective Retrospective Critique of methodology:


Wang JC, Nonconsecutive patients
Robertson Study design: RCT Nonrandomized
DP, et al. Type of Nonmasked reviewers
Reduction of evidence Stated objective of study: To compare discectomy to Nonmasked patients
radiculopathy therapeutic discectomy plus Oxiplex/SP gel No validated outcome measures used
and pain with Small sample size
Oxiplex/SP Type of treatment(s): discectomy, discectomy plus Oxiplex/SP <80% follow-up
gel after Lacked subgroup analysis
laminectomy, Total number of patients: 34 Diagnostic method not stated
laminotomy, Number of patients in relevant subgroup(s): 23 discectomy Other:
and plus Oxiplex/SP; 11 discectomy
discectomy:
a pilot clinical Consecutively assigned? No Work group conclusions
study. Spine. Potential Level: I
2003(10):108 Duration of follow-up: six months Downgraded Level: II
0-1087;
discussion Validated outcome measures used (list): Lumbar Spine Conclusions relative to question
1087-1088. Outcome Questionnaire This paper provides evidence that:the
http://www.m application of Oxiplex/SP gel results in no
rw.interscien Nonvalidated outcome measures used (list): leg pain, physical significant benefit to the overall patient
ce.wiley.com symptoms and functions self assessment scores, MRI, population. Some select patients with
/cochrane/clc postoperative assessment of scar significant leg pain scores and
entral/articles preoperative weakness may experience
/760/CN- Diagnosis made by: some short-term (30 day) benefits .
00451760/fra Clinical exam/history
me.html. Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): MRI showed


no difference and no statistical difference was found at any
time point. There was a trend towards improvement in leg
weakness and radiculopathy scores in the gel group only at the
30 day follow-up. When a post hoc analysis was performed in
patients with significant leg pain scores and weakness
preoperatively, there was a statistically significant difference in
several scores at 30 days. It is unclear if outcomes are
statistically significant at longer intervals.

Author conclusions (relative to question): Patients with a


herniated lumbar disc, significant pain and lower extremity
weakness reported clinical
benefit with the use of Oxiplex/SP Gel.

Masopust V, Level II Prospective Retrospective Critique of methodology:


Haeckel M, Nonconsecutive patients
Netuka D, Study design: RCT Nonrandomized
Bradc O, Type of Nonmasked reviewers
Rokyta R, evidence Stated objective of study: To assess the effectiveness of use of Nonmasked patients
Vrabec M. therapeutic steroids and fentanyl (direct application post decompression) No validated outcome measures used
Postoperativ following discectomy Small sample size
e epidural <80% follow-up
fibrosis. The Type of treatment(s): discectomy or discectomy with steroid Lacked subgroup analysis
Clinical plus fentanyl sponge Diagnostic method not stated
journal of Other: no power analysis (although may
pain. Total number of patients: 200 be meaningless given trend towards worse
2009(7):600- Number of patients in relevant subgroup(s): 167; 33 lost to outcomes in steroid group)
606. follow-up
http://www.m
rw.interscien Consecutively assigned? Yes Work group conclusions
ce.wiley.com Potential Level: I
/cochrane/clc Duration of follow-up: 12 months Downgraded Level: II
entral/articles
/616/CN- Validated outcome measures used (list): VAS, work status Conclusions relative to question
00719616/fra This paper provides evidence that:addition
me.html. Nonvalidated outcome measures used (list): MRI, assessment of steroid and fentanyl sponge to nerve
of surgical outcome during postoperative days 1-7, root does not appear to improve outcomes
assessment of incapacity for work with regard to VAS or work status

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): No


statistically significant differences were seen in VAS scores.
Epidural fibrosis was trending higher in the steroid group. No
differences were found in incapacity for work or correlation
between epidural fibrosis and change in VAS. No statistically
significant difference was found with initial results on t test, but
there was with Mann Whitney for the first follow-up period.

Author conclusions (relative to question): There is a


correlation between scar and pain postoperatively. Addition of
steroid and fentanyl sponge helps towards the end of the first
postoperative week, with no significance in the clinical picture,
but strong correlation to better outcomes with steroid mix.

Petrie JL, Level II Prospective Retrospective Critique of methodology:


Ross JS. Nonconsecutive patients
Use of Study design: RCT Nonrandomized
ADCON-L to Type of Nonmasked reviewers
inhibit evidence Stated objective of study: To assess whether ADCON-L leads Nonmasked patients
postoperativ therapeutic to decreased scarring postoperatively on MRI and better No validated outcome measures used
e peridural clinical outcomes Small sample size
fibrosis and <80% follow-up
related Type of treatment(s): one level lumbar discectomy with or Lacked subgroup analysis
symptoms without application of ADCON-L Diagnostic method not stated
following Other: no statistical analysis described
lumbar disc Total number of patients: 213
surgery: a Number of patients in relevant subgroup(s): 113 control and
preliminary 100 ADCON-L Work group conclusions
report. Potential Level: I
European Consecutively assigned? Yes Downgraded Level: II
spine journal
: official Duration of follow-up: six months Conclusions relative to question
publication of This paper provides evidence
the Validated outcome measures used (list): that:suggests that ADCON-L may be safe
European and effective in reducing scar and leading
Spine Nonvalidated outcome measures used (list): Hopkins scale, to better clinical outcomes. The work
Society, the degree of fibrosis as determined on MRI and subjectively by group expressed concerns about the
European the surgeon in reoperation failure to utilize validated outcome
Spinal measures or present actual data to
Deformity Diagnosis made by: support their results and conclusions.
Society, and Clinical exam/history
the Electromyography
European Myelogram
Section of MRI
the Cervical CT
Spine CT/Myelogram
Research Other:
Society.
1996:S10-
17. Results/subgroup analysis (relevant to question): ADCON-L
http://www.m showed 23% less extensive scarring and 120% more minimal
rw.interscien scarring (failed to state overall scarring numbers when
ce.wiley.com comparing both groups); scarring was associated with
/cochrane/clc increased pain; at reoperation, there was more scarring in the
entral/articles control group; ADCON-L group did clinically better at follow-up
/500/CN-
00133500/fra Author conclusions (relative to question): ADCON-L is safe
me.html. and effective in reducing scar and leading to better clinical
outcomes

Rogers LA. Level IV Prospective Retrospective Critique of methodology:


Experience Nonconsecutive patients
with limited Study design: comparative Nonrandomized
versus Type of Nonmasked reviewers
extensive evidence Stated objective of study: compare limited and aggressive Nonmasked patients
disc removal therapeutic discectomy No validated outcome measures used
in patients Small sample size
undergoing Type of treatment(s): removing herniation vs. removing entire <80% follow-up
microsurgical disc (had a third group of 68 patients that were laminectomy Lacked subgroup analysis
operations and aggressive discectomy) Diagnostic method not stated
for ruptured Other: no statistical analysis
lumbar discs. Total number of patients: 68
Neurosurger Number of patients in relevant subgroup(s): 33 discectomy
y. Jan only and 35 aggressive discectomy Work group conclusions
1988;22(1 Pt Potential Level: III
1):82-85. Consecutively assigned? Yes Downgraded Level: IV

Duration of follow-up: 11 - 30 months Conclusions relative to question


This paper provides evidence
Validated outcome measures used (list): none that:microsurgical discectomy results in
faster recovery than open laminectomy,
Nonvalidated outcome measures used (list): leg pain, hospital and limited discectomy has a high rate of
stay, time to return to work, recurrent disc herniation recurrences.

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): There were


no recurrent herniations in the aggressive group. Duration of
hospitalization and return to work were less for the
microsurgical group

Author conclusions (relative to question): recommend


microsurgical aggressive discectomy

Ronnberg K, Level I Prospective Retrospective Critique of methodology:


Lind B, Nonconsecutive patients
Zoega B, et Study design: RCT Nonrandomized
al. Peridural Type of Nonmasked reviewers
scar and its evidence Stated objective of study: To assess effectiveness of ADCON- Nonmasked patients
relation to therapeutic L in reducing scar and improving clinical outcomes. No validated outcome measures used
clinical Small sample size
outcome: A Type of treatment(s): one level lumbar discectomy with or <80% follow-up
randomised without application of ADCON-L Lacked subgroup analysis
study on Diagnostic method not stated
surgically Total number of patients: 119 with 11 lost to follow-up Other:
treated Number of patients in relevant subgroup(s): 60 ADCON-L and
lumbar disc 48 control
herniation Work group conclusions
patients. Consecutively assigned? Yes Potential Level: I
European Downgraded Level:
Spine Duration of follow-up: two years
Journal. Conclusions relative to question
2008;17(12): Validated outcome measures used (list): VAS This paper provides evidence that:addition
1714-1720. of ADCON-L does not improve outcomes
Nonvalidated outcome measures used (list): MacNab, review following discectomy.
of MRI

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): No


relationships were found between scar and pain, between
ADCON-L use and scar formation, or between ADCON-L use
and clinical outcomes.

Author conclusions (relative to question): ADCON-L does not


influence scar production and has no impact on scar or pain.

Ryang YM, Level IV Prospective Retrospective Critique of methodology:


Rohde I, Ince Nonconsecutive patients
A, Oertel MF, Study design: comparative Nonrandomized
Gilsbach JM, Type of Nonmasked reviewers
Rohde V. evidence Stated objective of study: To compare the efficacy of lateral Nonmasked patients
Lateral therapeutic transmuscular and combined interlaminar/paraisthmic No validated outcome measures used
transmuscula approach to treat lateral lumbar disc herniation Small sample size
r or <80% follow-up
combined Type of treatment(s): lateral transmuscular or combined Lacked subgroup analysis
interlaminar/ interlaminar/paraisthmic approach Diagnostic method not stated
paraisthmic Other:
approach to Total number of patients: 48
lateral Number of patients in relevant subgroup(s): 28 combined
lumbar disc interlaminar/paraisthmic approach and 20 lateral transmuscular Work group conclusions
herniation? A Potential Level: III
comparative Consecutively assigned? No Downgraded Level: IV
clinical series
of 48 Duration of follow-up: between 19 and 37 months Conclusions relative to question
patients. J This paper provides evidence that:a lateral
Neurol Validated outcome measures used (list): alone approach results in better outcomes
Neurosurg than a combined medial and lateral
Psychiatry. Nonvalidated outcome measures used (list): Ebling criteria; approach in the treatment of far lateral
Jul pain in lower back; radicular, sensory or motor deficit disc herniations.
2005;76(7):9
71-976. Diagnosis made by:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: CT in all and MRI in nine

Results/subgroup analysis (relevant to question): There was a


statistically significant improvement in overall excellent
outcomes in lateral transmuscular group. Even though 100%
of back pain resolved in both groups, the patients treated with
the combined approach had a 21% incidence of new back
pain.

Author conclusions (relative to question): Lateral


transmuscular approach leads to overall better outcomes and
is the preferred choice at the authors' institution.

Schick U, Level III Prospective Retrospective Critique of methodology:


Elhabony R. Nonconsecutive patients
Prospective Study design: comparative Nonrandomized
comparative Type of Nonmasked reviewers
study of evidence Stated objective of study: To assess clinical differences Nonmasked patients
lumbar therapeutic between sequestrectomy and microdiscectomy. No validated outcome measures used
sequestrecto Small sample size
my and Type of treatment(s): sequestrectomy and microdiscectomy <80% follow-up
microdiscect Lacked subgroup analysis
omy. Minim Total number of patients: 200 Diagnostic method not stated
Invasive Number of patients in relevant subgroup(s): 100 in each group; Other: <50% follow-up
Neurosurg. at follow-up 46 sequestrectomy and 45 microdiscectomy
Aug patients filled out ODI
2009;52(4):1 Work group conclusions
80-185. Consecutively assigned? No Potential Level: II
Downgraded Level: III
Duration of follow-up: average of 34 months
Conclusions relative to question
Validated outcome measures used (list): ODI; VAS, low back This paper provides evidence that:there is
and leg pain no significant difference between
aggressive discectomy and
Nonvalidated outcome measures used (list): sequestrectomy.

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): No back


pain and pain medication consumption at discharge for the
discectomy group, but more improvement in paresis (all
statistically significant). At final follow-up, no difference in leg or
back pain or ODI between groups. No difference in recurrence
rate.

Author conclusions (relative to question): Sequestrectomy is


safe with no higher rate of recurrent symptoms. It is the
recommended technique especially in young people where
preservation of disc height is key.

Thome C, Level II Prospective Retrospective Critique of methodology:


Barth M, Nonconsecutive patients
Scharf J, Study design: RCT Nonrandomized
Schmiedek Type of Nonmasked reviewers
P. Outcome evidence Stated objective of study: compare the results of disc fragment Nonmasked patients
after lumbar therapeutic removal with standard discectomy No validated outcome measures used
sequestrecto Small sample size
my Type of treatment(s): as above (curettes not used in standard <80% follow-up
compared disc) Lacked subgroup analysis
with Diagnostic method not stated
microdiscect Total number of patients: 84 Other:
omy: a Number of patients in relevant subgroup(s): 42 each group
prospective
randomized Consecutively assigned? Yes Work group conclusions
study. J Potential Level: II
Neurosurg Duration of follow-up: at least 12 months with 87% follow up at Downgraded Level:
Spine. Mar that time
2005;2(3):27 Conclusions relative to question
1-278. Validated outcome measures used (list): VAS, SF-36, Prolo This paper provides evidence
scale score and patient satisfaction index that:sequestrectomy does not lead to an
increased rate of recurrent disc herniations
Nonvalidated outcome measures used (list): and clinically trends towards better results
than conventional discectomy.
Diagnosis made by:
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to


question): Sequestrectomy took statistically less time.
Postoperative back and leg pain sign improved in both groups.
There was a trend towards increased low back pain and
sciatica at long-term follow-up, but this was not statistically
significant. Sequestrectomy trended better in all groups

Author conclusions (relative to question): Although long-term


follow-up examination is mandatory, sequestrectomy may be
an advantageous alternative to standard microdiscectomy.The
current study shows no increased rate of recurrent disc
herniation.

Tureyen K. Level II Prospective Retrospective Critique of methodology:


One-level Nonconsecutive patients
one-sided Study design: RCT Nonrandomized
lumbar disc Type of Nonmasked reviewers
surgery with evidence Stated objective of study: To assess outcomes of Nonmasked patients
and without therapeutic microdiscectomy versus macrodiscectomy No validated outcome measures used
microscopic Small sample size
assistance: Type of treatment(s): Microdiscectomy: small incision with <80% follow-up
1-year flavum excision, use of scope and minimal bony removal. Lacked subgroup analysis
outcome in Macrodiscectomy: hemilaminectomy and large incision Diagnostic method not stated
114 Other: randomization not quite right-
consecutive Total number of patients: 114 "differences in numbers due to our
patients. J. Number of patients in relevant subgroup(s): 63 familiarity with macrodiscectomy?"
Neurosurg. microdiscectomies and 51 macrodiscectomies
Oct
2003;99(3):2 Consecutively assigned? Yes Work group conclusions
47-250. Potential Level: I
Duration of follow-up: 10 days, one month and one year Downgraded Level: II
assessment
Conclusions relative to question
Validated outcome measures used (list): VAS This paper provides evidence
that:microdiscectomy allows more return
Nonvalidated outcome measures used (list): neurological to work and function with less narcotic use
examination than open surgery; however, no difference
between groups was observed relative to
Diagnosis made by: the primary outcome of VAS.
Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:
Results/subgroup analysis (relevant to question): VAS
improved significantly in both groups. Patients treated with
microdiscectomy had smaller incisions and showed a
statistically significantly greater improvement in muscle power,
lower narcotic use and more returned to work within four
weeks than the open discectomy group. Open discectomy took
less time.

Author conclusions (relative to question): Microdiscectomy


allows more return to work and function with less narcotic use
than open surgery.
Question #18:
What are the medium-term (1 - 4 years) and long-term (greater than four years) results of surgical
management of lumbar disc herniation?

Article Level
(Alpha by of Description of study Conclusion
Author) evidence

Bakhsh A. Level IV Prospective Retrospective Critique of methodology:


Long-term Nonconsecutive patients
outcome of Study design: case series Nonrandomized
lumbar disc Type of Nonmasked reviewers
surgery: an evidence Stated objective of study: determine the long-term Nonmasked patients
experience therapeutic outcome of lumbar disc surgery on relief of sciatic leg No validated outcome measures used
from pain Small sample size
Pakistan <80% follow-up
Clinical Type of treatment(s): surgical decompression including Lacked subgroup analysis
article. J. curretage Diagnostic method not stated
Neurosurg.- Other: essentially a clinical study
Spine. Total number of patients: 68
Jun;12(6):66 Number of patients in relevant subgroup(s): 54 initially
6-670. pain free Work group conclusions
Potential Level: IV
Consecutively assigned? No Downgraded Level:

Duration of follow-up: 10 years for 54 patients Conclusions relative to question


This paper provides evidence that:significant
Validated outcome measures used (list): Examination by pain relief from surgery can be obtained in a
a single physician to specifically evaluate sciatic pain majority of patients but for a substantial
portion of these, symptoms do recur.
Nonvalidated outcome measures used (list): Clinical
judgment, meticulous physical and neurological
examinations, and an up-to date medical record were the
only outcome measuring tools in this study.

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to


question): Though a large percentage (79%) of patients
were 'pain free' initially postoperatively, five of the 54 had
recurrence of their pain within one year, an additional 14
had recurrent sciatic pain by five years, and an additional
20 by 10 years. Only 27% had relief of their original pain
lasting 10 years.

Author conclusions (relative to question): Significant


pain relief from surgery was obtained in a majority of
patients but for a substantial portion of these, symptoms
did recur.

Findlay GF, Level IV Prospective Retrospective Critique of methodology:


Hall BI, Musa Nonconsecutive patients
BS, Oliveira Study design: case series Nonrandomized
MD, Fear Type of Nonmasked reviewers
SC. A 10- evidence Stated objective of study: evaluate long-term outcome of Nonmasked patients
year follow- therapeutic microdiscectiomy for herniated nucleus pulposus with No validated outcome measures used
up of the sciatica Small sample size
outcome of <80% follow-up
lumbar Type of treatment(s): lumbar microdiscectomy Lacked subgroup analysis
microdiscect Diagnostic method not stated
omy. Spine. Total number of patients: 88, all surgeries done in 1985 Other: postal questionnaire
1998;23(10): Number of patients in relevant subgroup(s): 79
1168-1171.
Consecutively assigned? Yes Work group conclusions
Potential Level: IV
Duration of follow-up: 90% of patients were followed for Downgraded Level:
10 years
Conclusions relative to question
Validated outcome measures used (list): MacNab and This paper provides evidence that:early
Roland Morris score microdiscectomy results hold up quite well at
10 years with only 17% unsatisfactory (fair
Nonvalidated outcome measures used (list): patient and poor) results versus nine percent (fair,
satisfaction poor) at six months

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: 'radiculography' and findings at surgery. The
reviewer was 'independent'.

Results/subgroup analysis (relevant to question): using


MacNab definition of "success and/or failure," in
comparing six month results
versus results at 10 years, 75% of patients were
''unchanged,' 18% deteriorated one grade (of 4), and 7%
improved a grade or more.

Author conclusions (relative to question): There is no


significant deterioration of the high success rate of
lumbar microdiscectomy at long-term follow-up. Success
was 91% at six months and 83% at 10 years. Four
patients (6%) required additional surgery. Results from
MacNab and Roland Morris studies were equivalent.

Loupasis Level IV Prospective Retrospective Critique of methodology:


GA, Stamos Nonconsecutive patients
K, Katonis Study design: case series Nonrandomized
PG, Sapkas Type of Nonmasked reviewers
G, Korres evidence Stated objective of study: assess the effects of Nonmasked patients
DS, therapeutic conventional surgery No validated outcome measures used
Hartofilakidis for lumbar disc herniation over an extended period of Small sample size
G. Seven- to time and to examine factors that might correlate with <80% follow-up
20-year unsatisfactory results Lacked subgroup analysis
outcome of Diagnostic method not stated
lumbar Type of treatment(s): discectomy Other:
discectomy.
Spine (Phila Total number of patients: 109
Pa 1976). Number of patients in relevant subgroup(s): 26 light Work group conclusions
Nov 15 work; 50 medium work; 33 heavy work Potential Level: IV
1999;24(22): Downgraded Level:
2313-2317. Consecutively assigned? No
Conclusions relative to question
Duration of follow-up: 12.2 years (range: 7-20 years) This paper provides evidence that:the
majority of patients treated with discectomy
Validated outcome measures used (list): ODI, modified have satisfactory long-term results, however,
StaufferCoventrys evaluating criteria 28% still had significant low back and leg
pain for the long term.
Nonvalidated outcome measures used (list):

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: radiography

Results/subgroup analysis (relevant to question): Late


results were satisfactory in 64% of patients. The mean
Oswestry disability score was 18.9. Of the 101 patients
who had primary procedures, 28 percent still complained
of significant back or leg pain. Sixty-five percent of
patients were very satisfied with their results, 29% were
satisfied, and six percent were dissatisfied. The
reoperation rate was
7.3 percent (eight patients), about one-third of which was
due to
recurrent disc herniation. Socio-demographic factors
predisposing
to unsatisfactory outcome included female gender, low
vocational education, and jobs that were significantly
physically strenuous. Disc space narrowing was common
at the level of discectomy, but was without prognostic
significance.

Author conclusions (relative to question): Long-term


results of standard lumbar discectomy are not very
satisfying. More than one-third of the patients had
unsatisfactory results and more than one
quarter complained of significant residual pain. Heavy
manual work, particularly agricultural work, and low
educational level were negative predictors of a good
outcome. These indicators should be used preoperatively
to identify patients who are at high risk for an unfavorable
long-term result.

Padua R, Level IV Prospective Retrospective Critique of methodology:


Padua S, Nonconsecutive patients
Romanini E, Study design: case series Nonrandomized
Padua L, de Type of Nonmasked reviewers
Santis E. evidence Stated objective of study: evaluate the outcome of Nonmasked patients
Ten- to 15- therapeutic standard surgery for disc herniation by means of an No validated outcome measures used
year analysis of long-term results in a large number of treated Small sample size
outcome of patients <80% follow-up
surgery for Lacked subgroup analysis
lumbar disc Type of treatment(s): discectomy for lumbar disc Diagnostic method not stated
herniation: herniation Other:
radiographic
instability Total number of patients: 150
and clinical Number of patients in relevant subgroup(s): 120 Work group conclusions
findings. Eur Potential Level: IV
Spine J. Consecutively assigned? No Downgraded Level:
1999;8(1):70
-74. Duration of follow-up: mean 12.1 years (range: 10-15 Conclusions relative to question
years) This paper provides evidence
that:discectomy yields good long-term (10-15
Validated outcome measures used (list): Roland years) results in the treatment of lumbar disc
Disability Questionnaire herniation with radiculopathy. However, the
results are difficult to interpret.
Nonvalidated outcome measures used (list): satisfaction
with surgery, four items regarding the presence of
peripheral pain

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): The


overall results of the Roland questionnaire show a score
of less than 5 in 107 of the 120 patients. All but 23.4% of
the patients were entirely satisfied, while only 4.2% were
unsatisfied. Leg pain also was considered a
rare condition.

Author conclusions (relative to question): The standard


procedure for disc herniation is still a good treatment,
given its safety and simplicity, unless there are elective
indications for microinvasive techniques. Furthermore,
the authors concluded that one of the most important
predictors for a good outcome in disc herniation is the
indication for surgery, and further studies must be
conducted in order to define indications.

Peul WC, Level II Prospective Retrospective Critique of methodology:


van Nonconsecutive patients
Houwelingen Study design: RCT Nonrandomized
HC, van den Type of Nonmasked reviewers
Hout WB, et evidence Stated objective of study: compare the efficacy of early Nonmasked patients
al. Surgery therapeutic surgical intervention with a strategy of prolonged No validated outcome measures used
versus conservative care and, if needed, subsequent surgery for Small sample size
prolonged patients with disabling sciatica. <80% follow-up
conservative Lacked subgroup analysis
treatment for Type of treatment(s): microdiscectomy at six weeks Diagnostic method not stated
sciatica. N versus attempt to avoid surgery followed by surgery 18 Other: crossover
Engl J Med. weeks later
May 31
2007;356(22) Total number of patients: 283 Work group conclusions
:2245-2256. Number of patients in relevant subgroup(s): 55 Potential Level: I
Downgraded Level: II
Consecutively assigned? Yes
Conclusions relative to question
Duration of follow-up: 52 weeks This paper provides evidence that:early
surgery provides faster pain relief. One-year
Validated outcome measures used (list): Roland outcomes were not different between
Disability Questionnaire, VAS leg pain treatment groups; however, there was a high
degree of crossover (40%) and an as-treated
Nonvalidated outcome measures used (list): analysis was not provided.

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): There


was no significant overall difference in disability scores
during the first year (P = 0.13). Relief of leg pain was
faster for patients assigned to early surgery (P<0.001).
Patients assigned to early surgery also reported a faster
rate of perceived recovery (hazard ratio, 1.97; 95%
confidence interval, 1.72 to 2.22; P<0.001). In both
groups, however, the probability of perceived recovery
after one year of follow-up was 95%.

Author conclusions (relative to question): The one-year


outcomes were similar for patients assigned to early
surgery and those
assigned to conservative treatment with eventual surgery
if needed, but the rates of pain relief and of perceived
recovery were faster for those assigned to early surgery.

Porchet F, Level IV Prospective Retrospective Critique of methodology:


Chollet- Nonconsecutive patients
Bornand A, Study design: comparative Nonrandomized
de Tribolet Type of Nonmasked reviewers
N. Long-term evidence Stated objective of study: evaluate long term outcomes Nonmasked patients
follow up of therapeutic for surgery for foraminal and extraforaminal lumbar disc No validated outcome measures used
patients herniation Small sample size
surgically <80% follow-up
treated by Type of treatment(s): far lateral discectomy Lacked subgroup analysis
the far-lateral Diagnostic method not stated
approach for Total number of patients: 202 Other:
foraminal Number of patients in relevant subgroup(s): according to
and level of surgery: L1-2=1; L2-3=9; L3-4=48; L4-5=86; L5-
extraforamin S1=58 Work group conclusions
al lumbar Potential Level: III
disc Consecutively assigned? No Downgraded Level: IV
herniations. J
Neurosurg. Duration of follow-up: 50 months Conclusions relative to question
Jan This paper provides evidence that:far lateral
1999;90(1 Validated outcome measures used (list): MacNab discectomy has relatively good long-term (50
Suppl):59- months) results.
66. Nonvalidated outcome measures used (list):
complications, recurrent lumbar disc herniation

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): Good


to excellent results were achieved in 73% and fair and
poor results in 27% of patients. There were 11 recurrent
lumbar disc herniations.

Author conclusions (relative to question): far lateral


discectomy is a good option for foraminal and
extraforaminal lumbar disc herniation

Weinstein Level II Prospective Retrospective Critique of methodology:


JN, Lurie JD, Nonconsecutive patients
Tosteson Study design: comparative Nonrandomized
TD, et al. Type of Nonmasked reviewers
Surgical vs evidence Stated objective of study: compare the treatment effects Nonmasked patients
nonoperative therapeutic of lumbar discectomy and usual care No validated outcome measures used
treatment for Small sample size
lumbar disk Type of treatment(s): lumbar discectomy, usual care <80% follow-up
herniation: Lacked subgroup analysis
the Spine Total number of patients: 743 Diagnostic method not stated
Patient Number of patients in relevant subgroup(s): 528 Other:
Outcomes
Research Consecutively assigned? Yes
Trial Work group conclusions
(SPORT) Duration of follow-up: two years Potential Level: II
observational Downgraded Level:
cohort. Validated outcome measures used (list): Short-Form
JAMA. Nov Health Survey (SF-36) bodily pain and physical function Conclusions relative to question
22 scales and the modified Oswestry Disability Index This paper provides evidence that:surgical
2006;296(20) (American Academy of Orthopaedic Surgeons/MODEMS treatment of lumbar disc herniation may
:2451-2459. version); Sciatica Bothersomeness result in earlier and greater improvement of
Index symptoms compared to nonoperative
treatment.
Nonvalidated outcome measures used (list): patient self-
reported improvement, work status, satisfaction with
current symptoms and
care

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): At


three months, patients who chose surgery had greater
improvement in the primary outcome measures of bodily
pain (mean change: surgery, 40.9 vs nonoperative care,
26.0; treatment effect, 14.8; 95% confidence
interval, 10.8-18.9), physical function (mean change:
surgery, 40.7 vs nonoperative care, 25.3; treatment
effect, 15.4;95%; CI, 11.6-19.2), and Oswestry Disability
Index (mean change: surgery, 36.1 vs nonoperative
care, 20.9; treatment effect, 15.2;95%; CI, 18.5. to
11.8). These differences narrowed somewhat at two
years: bodily pain (mean change: surgery, 42.6 vs
nonoperative care, 32.4; treatment effect, 10.2; 95% CI,
5.9-14.5), physical function (mean change: surgery, 43.9
vs nonoperavtive care 31.9; treatment effect, 12.0; 95%
CI; 7.9-16.1), and Oswestry Disability Index (mean
change: surgery 37.6 vs nonoperative care 24.2;
treatment effect, 13.4;95%CI, 17.0 to 9.7).

Author conclusions (relative to question): Patients with


persistent sciatica from lumbar disc herniation improved
in both operated and usual care groups. Those who
chose operative intervention reported
greater improvements than patients who elected
nonoperative care. The effects of surgery persisted at
two year follow-up.

Weinstein Level II Prospective Retrospective Critique of methodology:


JN, Tosteson Nonconsecutive patients
TD, Lurie JD, Study design: RCT Nonrandomized
et al. Type of Nonmasked reviewers
Surgical vs evidence Stated objective of study: assess the efficacy of surgery Nonmasked patients
nonoperative therapeutic for lumbar intervertebral disc herniation compared to No validated outcome measures used
treatment for nonoperative care Small sample size
lumbar disk <80% follow-up
herniation: Type of treatment(s): lumbar discectomy vs usual care Lacked subgroup analysis
the Spine Diagnostic method not stated
Patient Total number of patients: 472 Other: high crossover
Outcomes Number of patients in relevant subgroup(s): 232
Research
Trial Consecutively assigned? Yes Work group conclusions
(SPORT): a Potential Level: I
randomized Duration of follow-up: two years Downgraded Level: II
trial. JAMA.
Nov 22 Validated outcome measures used (list): Short-Form Conclusions relative to question
2006;296(20) Health Survey (SF-36) bodily pain and physical function This paper provides evidence that:outcomes
:2441-2450. scales and the modified Oswestry Disability Index for surgery appear durable at two year
(American Academy of Orthopaedic Surgeons/MODEMS follow-up, however, it is difficult to interpret
version); Sciatica Bothersomeness the data due to high crossover rate and no
Index analysis of specific symptoms.

Nonvalidated outcome measures used (list): patient self-


reported improvement, work status, satisfaction with
current symptoms and
care

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other:

Results/subgroup analysis (relevant to question): at


three months, one year, and two years for each measure
and at each point, the treatment effect favors surgery.
The treatment effects for the primary outcomes were
small and not statistically significant at any of the points.
Both treatment groups showed strong improvements at
each
of the designated follow-up times, with small advantages
for surgery. However, for each primary outcome the
combined global test for any difference at any period was
not statistically significant. As-treated analyses based on
treatment received were performed with adjustments for
the time of surgery and factors affecting treatment
crossover and missing data. These yielded far different
results than the intent-to-treat analysis, with strong,
statistically significant advantages seen for surgery at all
follow-up points through two years.
Author conclusions (relative to question): Patients in
both the surgery and nonoperative treatment groups
improved
substantially over the first two years. Between-group
differences in
improvements were consistently in favor of surgery for all
outcomes and at all time periods but were small and not
statistically significant except for the secondary
measures of sciatica severity and self-rated
improvement. Because of the high numbers of patients
who crossed over in both directions, conclusions about
the superiority or equivalence of the treatments are not
warranted based on the
intent-to-treat analysis alone.

Wenger M, Level IV Prospective Retrospective Critique of methodology:


Mariani L, Nonconsecutive patients
Kalbarczyk Study design: case series Nonrandomized
A, Groger U. Type of Nonmasked reviewers
Long-term evidence Stated objective of study: report the late outcome of 104 Nonmasked patients
outcome of therapeutic consecutive patients after Williams sequestrectomy No validated outcome measures used
104 patients Small sample size
after lumbar Type of treatment(s): Williams sequestrectomy <80% follow-up
sequestrecto Lacked subgroup analysis
my according Total number of patients: 121 Diagnostic method not stated
to Williams. Number of patients in relevant subgroup(s): 104 Other:
Neurosurger
y. Aug Consecutively assigned? Yes
2001;49(2):3 Work group conclusions
29-334; Duration of follow-up: average 5.3 years (range, 4.16.9 Potential Level: IV
discussion years) Downgraded Level:
334-325.
Validated outcome measures used (list): none Conclusions relative to question
This paper provides evidence
Nonvalidated outcome measures used (list): patients that:sequestectomy is effective treatment for
described lumbago, leg pain, and motor and urinary lumbar disc herniation at five year follow-up
bladder dysfunction at
that time, and they compared these results with their
preoperative
status. They classified their outcome in five categories:
excellent (asymptomatic), good (significantly improved),
fair
(improved), unchanged, or worse.

Diagnosis made by:


Clinical exam/history
Electromyography
Myelogram
MRI
CT
CT/Myelogram
Other: operative exam

Results/subgroup analysis (relevant to


question): Success rates, including excellent, good, and
fair results, were 92.5%, 94.7%, and 93.3% for
lumbalgia, radicular pain, and neurological dysfunction,
respectively.

Author conclusions (relative to question):


sequestrectomy alone is a safe operative modality. It
should be used whenever possible. As demonstrated in
this series with a long follow-up time, the results are as
favorable as or better than results after standard
microsurgical lumbar discectomy with curettement of the
interspace.
Question #20:
What is the cost-effectiveness of treatment options in the management of lumbar disc herniation?

Article
(Alpha by Description of study Conclusion
Author)
Karppinen J, Prospective Retrospective Critique of methodology:
Ohinmaa A, No validated outcome measures
Malmivaara A, Study design: RCT used
et al. Cost Small sample size
effectiveness of Stated objective of study: Describe the cost effectiveness of periradicular Lacked subgroup analysis
periradicular infiltration with steroid in subgroups of patients with sciatica. No sensible alternatives utilized
infiltration for No sensible costs utilized
sciatica: Type of treatment(s): Treatment group: single transforaminal epidural steroid Limited alternatives and costs
subgroup injection. Control group: transforaminal injection of normal saline. Poor estimates
analysis of a No sensitivity analysis
randomized Total number of patients: 160 performed
controlled trial. Number of patients in relevant subgroup(s): Transforaminal epidural steroid Other: Inclusion criteria allowed
Spine (Phila Pa injection/Transforaminal normal saline injection: Bulges:18/11; Contained: degenerative spondylolisthesis
1976). Dec 1 24/26; Extrusions: 38/43. and spinal stenosis.
2001;26(23):258
7-2595. Consecutively assigned? Yes Work Group Conclusions
Conclusions relative to question
Duration of follow-up: one year This paper provides evidence
that:At one year a single
Validated outcome measures used (list): VAS transforaminal epidural steroid
injection prevented operations for
Nonvalidated outcome measures used (list): Direct costs contained lumbar disc herniations
saving $12,666 per patient
Measures of cost effectiveness used: responder.
Quality Adjusted Life Year (QALY)
Used to compare:
EQ-5D
Used to compare:
SF-6D
Used to compare:
Incremental Cost-Effectiveness Ratio (ICER)
Used to compare:
Other: CEA
Used to compare: Compare the average costs associated with a single
transforaminal epidural steroid injection with transforaminal normal saline
injection to obtain at least 75% improvement in leg pain in patients with
contained and extruded disc herniations. Nonresponders underwent
surgery.

Sensible costs and alternatives? No

Values obtained from:


many studies
limited studies

Sensitivity analyses performed:


Multiway analysis
One way analysis
Other:
None

Results (including specific data on value measures assessed and comparison


made between treatments): Compared to transforaminal epidural steroid
injection at 12 months, it costs $12,666 more per patient to obtain one
painless patient in the transforaminal saline injection group. Conversely, for
lumbar disc extrusions, costs in the transforaminal epidural steroid group were
$4,445 more per painless patient. The additional cost at 12 months was the
result of the higher rate of surgical treatment.

Author conclusions (relative to question): Transforaminal epidural steroid


injection is cost effective for contained herniations, seemingly by preventing
surgery, which results in savings at one year of $12,666 per responder. For
extrusions the treatment seems to be counter-effective. In this study there was
an increase in surgery for this patient group.

Author perspective: Physician/Researcher

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