David Borenstein, MD Clinical Professor of Medicine Arthritis and Rheumatism Associates The George Washington University Medical Center Washington, DC

Chronic Low Back Pain
Issues for Discussion 1. Define the forms of chronic low back pain and its prevalence (Is it frequent and important enough to study?) 2. Will patient selection including etiology and severity influence the performance of drugs in development? (Is it possible to identify and separate the individuals with back pain?) 3. Which are the appropriate outcome measures? (Can improvements in back pain related to therapy be determined?)

Chronic Low Back Pain
Issues for Discussion 4. Will a general indication be useful for different labeling claims? (somatic v. neuropathic v. chronic headache) 5. Chronic low back pain - serve as a measure of efficacy for a general chronic pain indication or specific indication for chronic low back pain alone


LOW BACK PAIN DEFINITION Pain that occurs in an area with boundaries between the lowest rib and the crease of the buttocks .

Chronic Low Back Pain • Duration greater than 3 months • Pain that persists longer than the expected time period for healing .

> 1 year 8.8% of claims .50:120-125 Hashemi L et al: J Occup Environ Med 1998.64.40:1110-1119 .9%-84.7% of annual costs ___________________________________ CDC.5% of the total disabilities in > 18 yo in 1999 • Workers’ compensation 1986-1996 .Epidemiology of Low Back Pain • 20% of the US population develops back pain yearly • Back pain -second most common cause of disability in the US (leading cause among men) accounting for 16. MMWR 2001.

duration-median 6 weeks __________________________________________ van den Hoogen et al: Ann Rheum Dis 1998. Netherlands 269 completed survey .less pain answered less often 7 weeks-median time to recover At 12 weeks-35%.57:13-19 . 52 weeks-10% had LBP 75% had 1 or more relapses during study Pain and disability was less during relapses Time to relapse-median 7 weeks.Natural History of Low Back Pain 443 LBP subjects postal questionnaire 12 months 15 general practices Amsterdam.

Wiesel S.Low Back Pain .Disorders Mechanical Rheumatologic Infectious Neoplastic Endocrinologic (N > 60) Referred Hematologic Neurologic Psychiatric Miscellaneous _____________________________________ Borenstein D. Boden S: Low Back Pain: Medical Diagnosis and Comprehensive Management. 1995 .

spondylolisthesis Scoliosis . tendon strain Discogenic disorders including herniated disc Apophyseal joint arthritis Spinal stenosis Spondylolysis.Disorders Mechanical .Low Back Pain . ligament.85% of all low back pain • • • • • • Muscle.

skin • Deep somatic .mixed motor sensory nerves • Psychogenic .Sources of Low Back Pain • Superficial somatic . joint.muscle.nerve root • Visceral referred .cerebral cortex .sympathetic afferents • Neurogenic . tendon. fascia • Radicular . bursa.

incapacitating function . mild dysfunction • Moderate .mentioned in passing. normal function • Mild .major component of symptoms.component of symptoms.the disease symptom.Pain Intensity • Minimal . alters function • Severe .

1966. Symposium on Idiopathic Low Back Pain.Diagnostic Evaluation Diagnosis of low back pain is unspecified in 80% of patients _________________________________________ Dillane JB et al: Acute back syndrome: a study from general practice.11:161-169 White AA. J Occup Med 1969. Gordon S. BMJ.2:82-84 Rowe ML: Low back pain in industry: a position paper. Mosby Co. 1982 .

joint.LOW BACK PAIN DIAGNOSIS • Specific diagnosis is possible • Differentiation of muscle. ligamentous structures • Mechanical versus systemic disorders is possible • Categorize by clinical symptoms • Subtyping will improve therapy _____________________________________ Abraham I. Killackey-Jones B: Arch Intern Med 2002.162:1442-1444 .

LOW BACK PAIN DIAGNOSIS • Specific diagnosis is impossible • Anatomic abnormalities in asymptomatic individuals • Overutilization of imaging techniques • Inconsistency of physical findings • Non-specific therapy is effective ____________________________________ Deyo RA: Arch Intern Med 162:1444-1446. 2002 .

radicular pains can be differentiated • Specific pain generators (individual joint or muscle) are difficult to identify but localization is not essential for effective therapy . neuropathic v.LOW BACK PAIN DIAGNOSIS • Somatic v.

Outcome Measures • Back specific function • Pain • Patient global satisfaction .Chronic Back Pain .

Outcome Measures Back Specific Function Roland Morris Disability Questionnaire Oswestry Disability Index .Back Pain .

Morris R: Spine 1983.8:141-144 .Back Pain .Outcome Measures Roland-Morris Disability Questionnaire function assessment • 24 items from the Sickness Impact Profile • Functions affected by back pain that day • Scores added ( 0-no disability to 24 maximum disability) • Validated and reproducible instrument ___________________________________ Roland M.

Pynsent P: Spine 2000.Back Pain . 25:2940-2953 .Outcome Measures Oswestry Disability Index .pain and function assessment • 10 sections on various functions with 6 levels of assessment • Physical and social functions that day • Scores added (0-no disability to 100maximum disability) • Validated and reproducible instrument _____________________________________ Fairbank J.

Outcome Measures Pain Measurement SF-36 pain scale Visual analog scale (VAS) Brief Pain Inventory (BPI) Treatment Outcomes in Pain Survey (TOPS) .Back Pain .

Back Pain . very. very. somewhat satisfied Mixed Somewhat. extremely dissatisfied .Outcome Measures Global Satisfaction Extremely.

Outcome Measures (Optional) • General health status – SF-36 • Depression – Beck Depression scale .Back Pain .

Back Pain .Outcome Measures • Instruments exist to measure the effect of drug interventions on chronic back pain for: – – – – function pain global satisfaction general health status .

Multimodality Back exercises .flexion and/or extension Aerobic exercise Medications Counterirritant topical therapies Stress management .Chronic Low Back Pain Therapy .

Medications NSAIDs Muscle relaxants Analgesics Antidepressants Anticonvulsants Alpha-2 adrenergic agonists Miscellaneous NONE ARE INDICATED FOR CHRONIC LOW BACK PAIN! .Chronic Low Back Pain .

2 inhibitors – equal efficacy .25:2501-2513 .decreased toxicity • van Tulder et al: Spine 2000. quick onset • Long half-life – sustained effect • Cox .NSAIDS • Short half-life – acute exacerbations.Chronic Low Back Pain Medications .

Chronic Low Back Pain Medications .Muscle Relaxants • • • • • Cyclobenzaprine Orphenadrine Metaxolone Chlorzoxazone Methocarbamol .

Analgesics • Nonnarcotic – Acetaminophen – Tramadol • Narcotic – Short acting – Long acting .Chronic Low Back Pain Medications .

Chronic Somatic Pain .Case Study .Mild To Moderate • 52 year old person .work-related myofascial injury – Treatment regimen • • • • Change of NSAID .diclofenac 100mg QD Maintain methocarbamol 750mg BID Diclofenac 50mg prn acute exacerbations maintain exercises program .

Chronic Somatic Pain .Case Study .Mild to Moderate • 67 year old person .facet arthritis – Treatment regimen • Rofecoxib 25mg QD • Cyclobenzaprine 10 mg QHS .

s/p laminectomy with fractured screw – Treatment regimen • • • • Celecoxib 200mg BID Nortriptyline 50mg QHS Fentanyl patch 50 mcg Hydrocodone 5 mg prn .Case Study .Chronic Somatic Pain .Moderate to Severe • 72 year old person .

Moderate to Severe .long acting .5mg PRN Case Study .Chronic Neuropathic Pain .7.200mg QD Gabapentin .40mg TID Hydrocodone .• 42 year old person .long acting .traumatic neuropathy sciatic nerve – Treatment regimen • • • • Ketoprofen .100mg TID Oxycodone .

effect on study design – mild to moderate .stable multidrug regimen flare with withdrawal .Chronic Low Back Pain Summary • • • • Model for chronic pain Outcome tools are available Somatic pain is identifiable Degree of pain .single drug v. placebo (active comparator) – moderate to severe .