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    lumbar herniation

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    © All Rights Reserved
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    8 views10 pages

    Joc60155 2441 2450

    Uploaded by

    yudhafp
    lumbar herniation

    Copyright:

    © All Rights Reserved
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    Him ORIGINAL CONTRIBUTION Surgical vs Nonoperative Treatment for Lumbar Disk Herniation The Spine Patient Outcomes Research Trial (SPORT): A Randomized Trial James N. Weinstein, DO, ME Context _Lumbar diskectomy is the most common surgical procedure performed for Tor D- Tosteson, SeD back and leg symptoms in US patents, but the efficacy ofthe procedure relative to Jon Lani MD. MSTTC inoperative care remains controversial Smaak Towcam SD TT (Objective To assess the efficacy of surgery for lumbar intervertebral dik herniation. Twine Me é sign, Setting, and Patients The Spine Patient Outcomes Research Trial, aran- - domized circa tal enroling patients between March 2000 and November 2004 from Jonathan S: Skinner, PRD ‘13 multdscipinary spine clines in 11 USstates, Patients were 501 surgical candidates Vila A. Abdu, MD, MS (emean age, 42 years; 42% women) with imaging-confimed lumbar intervertebral disk hemiation and persistent signs and symptoms of radiculopathy for atleast 6 weeks, Interventions, Standard open diskectomy vsnonoperatve treatment individualized tothe patent Main Outcome Measures Primary outcomes were changes fom basen fo the UMBARDISKECTON ISTHE Most foncon sales and he oaiied Oswesty Dea Indes Camesexe academy of Or common surgical procedite thopaed surgeons MODEMS version et 6 week 3 months montis and 1nd performed in the United States years from enrolment, Secondary outcomes included slatica seventy as measured by forpauentshavingbackandleg, Ye Scuteaothesomenes nde ststacton with symplors sel ported improve. ympumslinewsstmajontyotthe pro men and enpayment sus cedures are elective. However, lumbar Results Adherence to assigned treatment was limited: 50% of patients assigned to disk herniation is often seen on imag- _ surgery received surgery within 3 months of enrollment, while 30% of those assigned ing studies in the abeence of symp__ tosgroperave ecient received surgery resume period Intent tovest ec tona'and ean egren overtime Ses daronsated subst mproverseks al pry aed secndary otc see ee canee abot tetment groups Betwocr seu dfrencsn proven ere cons our surge Upto 15 fold variation n yn avr srg oral pets but were smal andro stats signa States’ and lower rates internationally _ fo" the primary outcomes. ricqucioe egndingihcapprepth Conelusions.Paterts in both the surgery andthe nonoperative treatment groups ‘ae qucstons zing he aprons Fyoved sostantaly over ayes posed Secae of te ge numbers of pets ness of some ofthese surgeries" TH ose overin both decors, conaisions abut the suey or equals panel aude hee compares fe esmen rent waren ued on eet ose ony Fe LP eal Registration 10° angular motion or >4-mm translation), vertebral fractures, spinein- fection oF tumor, inflammatory spondy= loarthropathy,preghancy,comorbid con- ditions contraindicating surgery, oF inability/anillingness to have surgery ‘within 6 months, Study Interventions The surgery was a standard open dis- kectomy with examination of the in- volved nerve root.!®"* The procedure agreed on by all participating centers was performed under general of local anesthesia, with patients in the prone ‘or knee-chest position, Surgeons were encouraged (0 use loupe magnifica- lion oF a microscope. Using a midline incision reflecting the paraspinous muscles, the interlaminar space Was en- tered as described by Delamarter and. MeCullough." In some cases the me- dial border of the superior facet was re- moved to providea clear view of the in- volved nerve rool. Usingsmall annular incision, the fragment of disk was r moved as described by Spengler." The ccanal was inspected and the foramen probed for residual disk or bony pa thology. The nerve root was decom- pressed, leaving it freely mobile. The nonoperative treatment group received “usual care,” with the study protocol recommending that the mini- mum nonsurgical treatment include atleast active physical therapy, educa- Lion/counseling with home exercise n= struction, and nonsteroidal ant inflammatory drugs, iftolerated, Other nonoperative treatments were listed, and physicians were encouraged to in- dividualize treatment to the patient; all nonoperative treatments were tracked. prospectively. (©2006 American Medical Assoc Downloaded From: on 01/31/2018 tion. Al rights reserved. (Reprinted) AMA, November 220, SURGICAL VS NONOPERATIVE TREATMENT FOR LUMBAR DISK HERNIATION ‘Table 1. Pabent Bsestne Demographic Characenrice, Comore Condiione Cite Fara and Health Status Measures" Pata NeTAT (n= 222) NonoperativeTeatent a Ze Eh 225 08) 22 64) Ter Ta aed a7 Empey "Fale cepa ie 1us.62) Sri ‘Sonpeneatort Bosh mass nen nen SO song a7) Tae, Tro nea aoa aE Damateral pan rt Parah aragiteg ase Testo ure) 5115) Ts Ko, EG 60 5 Te ero ore T5769) BL TERT 51 a EEO 15459 BES) Saisacion wih setae vay GaSe TTT Pater af asesoed heal rend Prouer gating bat 4800 vol 296, No. 20- 2448 ‘SURGICAL VS NONOPERATIVE TREATMENT FOR LUMBAR DISK HERNIATION Trereen ‘Esteator/cmuneeing 209 63) Emergency department 52110) Surgeon 11967, CChropractor ‘a6 (11) Irtamatheurlogsvether 105 (20) piven hySial therapist 142 4) Acupuncturist 131g) injectors 18065) Other 102 62) Madicaons| NSADe 193 60) (COX? inhiitore 101 Bt) Oral steels 1815) Newcates 187 to) Muscle relaxants ‘6 20) Other 1263, Devas ‘race 86 Corset 91) Magnets 2) Grthopede pilow sei) Shoe neers 2508) TENS dice iy thar medical devices 278 on 216 65) ‘Study Measures The primary measures were the Medi- cal Outcomes Sturdy 36-ltem Short- Form Health Survey (SP-36) bodily pain and physical fanction scales! and the American Academy of Orthopaedic Sur- ‘geons MODEMS version of the Oswe- stry Disability Index (ODD.* As specl- fied in the trial protocol, the primary ‘outcomes were changes from baseline these scales at 6 weeks, 3 months, 6 months, and 1 and 2 years from enrollment, Secondary measures included pa- tient self-reported improvement, work. status, and satisfaction with current symplomsand with care.» Symptom se- verity was measured by the Seiatica Both- cersomeness Index (range, 0-24 higher scores represent worse symptoms). Recruitment, Enrollment, A research nurse at each site identi- lied potential participants and verified 2444 JAMA. November 2229, 2006 Vol 296, No. 20 (Reprinted) Downloaded From: on 01/31/2018 eligibility. For recruitment and in- formed consent, evidence-based vid- cotapes described the surgical and non- ‘operative treatments and the expected benefits, risks, and uncertainties.” Participants were offered enrollment in either the randomized trial or a con- current observational cohort, the re sults of which are reported in a com- panion article. Enrollment began in March 2000 and ended in November 2004. Baseline vati- ables were collected prior to random- ‘zation, Patients self-reported race and ethnicity using National Institutes of Health categories Computer-generated random treal- ment assignment based on permuted blocks (randomly generated blocks of 6, 8, 10, and 12)" within sites oc curred immediately ater enrollment via an aulomated system at each site, en- suring proper allocation concealment Study measures were collected at base- line and at regularly scheduled fol- low-up visits, Short-term follow-up vis- lis occurred at 6 weeks and 3 months. surgery was delayed beyond 6 weeks, additional follow-up data were ob- tained 6 weeks and 3 months postop- eratively. Longer-term follow-up vis lts occurred at 6 months, 1 year from enrollment, and annually thereafter. Statistical Analyses We originally determined asamplesize of 250 patients in each treatment group to be sufficient (with a 2-sided signifi- cance level of .05 and 85% power) 10 detect a 10-point difference in the SF-36 bodily pain and physteal functioning scales ora similar effect size in the ODL. This difference corresponded to pa- dents’ reports of being “a litle better” in the Maine Lumbar Spine Study (MLSS). The sample size calculation allowed for up to 20% missing data bust, did not account for any specific levels of nonadherence TThe analyses for the primary and sec- ondary outcomes used all available data foreach period on an intent-to-treat ba- sis, Predetermined end points for the study inchided results at each of 6 weeks, 3 months, 6 months, 1 year,and 2 years. To adjust forthe possible effect, fof missing data on the study results, the analysis of mean changes for contint- ous outcomes was performed using maximum likelihood estimation for longitudinal mixed-effects models un- der “missing al random” assumptions and including a tert for treatment cen- ler. Comparative analyses were per formed using the single imputation methods of baseline value carried for- ‘ward and last value carried forward, as ‘wellasa longitudinal mixed model con- trolling for covariates associated with missed visits.° For binary secondary outcomes, lon- sgltudinal logistic regression models ‘were fited using generalized estimat- ing equations" as implemented in the PROC GENMOD program of SAS ve sion 9.1 (SAS Institute Ine, Cary, NC), Treatment effects were estimated as di ferences in the estimated proportions in the 2 treatment groups. P<.05 (2-sided) was used to estab- lish statistical significance. For the pri- ary outcomes, 05% confidence inter vals (Cls) for mean treatment effects ‘were calculated at each designated time point. Global tests ofthe joint hypoth esis of no treatment effect atany of the designated periods were performed us- ing Wald tests™ as implemented in SAS. These tests account for the intraindi- vidual correlation due to repeated mea- Nonadherence to randomly as- signed (reatment may mean that the intention-to-treat analysis tunde: estimates the real benefit of the treat- ment." As a preplanned sensitivity analysis, we also estimated an “as- treated” longitudinal analysis based on comparisons of those actually treated surgically and nonoperatively. Re- peated measures of outcomes were used as the dependent variables, and treat- ment received was included as a tims varying covariate, Adjustments were made for the time of surgery with r spect to the original enrollment date to approximate the designated follow-up limes. Baseline variables that were in dividually found to predict missing dataor treatment received at 1 year were (©2006 American Medical Association, All rights reserved. included to adjust for possible con- founding, RESULTS SPORT achieved full enrollment, with 501 (25%) of 1991 eligible patients en- rolled in the randomized tral. A total of 472 participants (04%) completed at least 1 follow-up visit and were in- cluded in the analysis, Data were avai able for between 86% and 73% of pa- ents at each of the designated follow-up times (FicuRE 1). tient Characteristics Baseline patient characteristics are shown in Taste 1. Overall, the study population hada mean age of 42 years, ‘with majorities being male, white, em- ployed, and having attended at least some college; 16% were receiving dis- ability compensation. All patients had radicular leg pain, 9796 in a classic der matomal distribution, Most of the her nlations were at L5-S1, posterolateral, and were extrusions by imaging crite- nia." The 2 randomized groups were similar at baseline ‘Nonoperative Treatments A variety of nonoperative treatments ‘were used during the study (TABLE 2) Most patients received education! counseling (03%) and anti-inflamma- tory medications (61%) (nonsteroidal anti-inflammatory drugs, cyclooxyge- nase 2 inhibitors, or oral steroids); 46% received opiates; more than 50% re- ceived injections (eg, epidural ste- roids); and 20% were prescribed activ- ity restriction. Forty-four percent received active physical therapy dur- ing the trial; however, 67% had re- ceived it prior to enrollment, ‘Surgical Treatment and Complications TARLE3 gives the characteristics of sur- sical treatment and complications. The median surgical time was 75 minutes Gnterquartile range, 58-90), with ami dian blood loss of 49.5 mL (interquar- tile range, 25-75). Only 2% required transfusions, Thet e were no periopers tive deaths; 1 patient died from com- (©2006 American Medical Assoc Downloaded From: on 01/31/2018 1, All rights reserved. SURGICAL VS NONOPERATIVE TREATMENT FOR LUMBAR DISK HERNIATION plications of childbirth 11 months af- {er enrollment. The most common intraoperative complication was dural tear (4%). There were no postopers- Live complications in 95% of patients, Reoperation oceurred in 4% of pa dents within 1 year of the initial sur- gery; more than 50% of the reopers- UUons were for recurrent herniations at the same level. Nonadherence Nonadherence to treatment assign- ‘mentalfected both groups, ie, some pa tients in the surgery group chose to de- lay or decline surgery nonoperative treatment group crossed over to receive surgery (Figure 1). The characteristics of erossover patients that were statistically different from pa- tients who did not eross over are shown, in TABLE 4, Those more likely to cross over to receive surgery tended to have lower incomes, worse baseline symp- toms, more baseline disability on the ODI, and were more likely to rate their symptoms as getting worse at enroll- ment than the other patients receiving nonoperative treatment. Those more likely to cross over to receive nonop- erative care were older, had higher in- comes, were more likely to have an up- per lumbar disk herniation, less likely to have a positive straight leg-raising test result, had less pain, better physt- cal function, less disability on the ODI, and were more likely to rate their symp- toms as getting hetter at enrollment than the other surgery patients. and some in the ‘Missing Data The rates of missing data were equiva- lent between the groups at each time point, with no evidence of differential dropout according to assigned treat- ‘ment, Characteristics of patients with missed visits were very similar to those of the rest ofthe cohort except that pa tients with missing data were less likely to be married, more likely to be ree ing disability compensation, more likely to smoke, more likely to display base- line motor weakness, and had lower baseline mental component summary scores on the SP-36. ‘Table 3: Operative Testers, Complications, and Events No ea. Daecony eer oath ou tas. eas eo 145 61) Operation time, mean (S0),min 71/363) ‘bodies, mean SD}, mL 04.7 fae} Blood repcerent 42) Leng of say ‘Same cay 9527) thet 1376) i 37 (15) Irirggperive compicationst ‘Bia tear spinal fu ak 1014 Vaseul ny 110) ther 213) one 230 (85) Postoperative compleatons/aventst ‘Wound nection, syperiial = 42) Other oi None 228 85) Peteugical reoperation, No fate ty ‘Actonal urgery ow ecurenthernaton 512) Compleaton orether 4.2) New eoneton| é ay ‘tonal surgery 1369 Pecurenthernaton —'8(3) Gompleaton rather 4.2) ew coneton| é Intent-to-Treat Analyses TARLE 5 shows estimated mean changes Irom baseline and the treatment ef- fects (differences in changes from base line between treatment groups) for 3 months, 1 year, and 2 years. For each measure and at each point, the treat ment elfect favors surgery. The treat ment effects for the primary outcomes ‘were small and not statistically signil- ceant at any of the points, As shown in FicuRe 2, both treatment groups showed strong improvements at each of the designated follow-up times, with small advantages for surgery. How- ever, for each primary outcome the combined global test for any dilfer- cence at any period was not statistically (Reprinted) JAMA, November 2229, 2006 296, No. 20.2445 ‘SURGICAL VS NONOPERATIVE TREATMENT FOR LUMBAR DISK HERNIATION ‘Table 4, Statitcaly Sinicant Ssssine Demographie Characters Comarbia Conditone,Clncal ncings, and Heath Status Mensur, by Adherence With Testment Assignment Fasignedo Surgery ‘signed to Nonoperave Treatment e surge p Valuer inst Value* Ramen SO a2) oT aroTtOm, zi Ranualincone "" Compared with the MLSS, SPORT had lower use of ac~ tivity restriction, spinal manipulation, (©2006 American Medical Assoc Downloaded From: on 01/31/2018 ton, AIL rights reserved. SURGICAL VS NONOPERATIVE TREATMENT FOR LUMBAR DISK HERNIATION transcutaneous electrical nerve stimu lation, and braces and corsets, and higher rates of epidural steroid injec ions and use of narcotic analgestes This lexible nonoperative protocol had the advantages of individualization that considered patient preferences in the choice of nonoperative treatment and of reflecting current practice among smultidiseiplinary spine practices. How- ever, we cannot make any conclusion regarding the effect of surgery vs any specific nonoperative treatment. Simi- larly, we cannot adequately assess the relative efficacy of any dilferences in surgical technique. CONCLUSION Patients in both the surgery and non- operative treatment groups improved substantially over the first 2 years. Between-group differences in improvements were consistently in favor of surgery for all outcomes and atall ume 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 treat- iments are not warranted based on the intent-to-treat analysis alone, ‘Author Contbuton: Dr Wis had ful aces toallofthedatain the study and tales esponstlty fect integty ofthe data athe accuracy of the (tana ‘Stuy concept and design: Weistin,T. Tosesn, ine, A Testes ‘Acguistbon of daa: Weinst,T.Tstson, Lv ‘aed, Hltran, Boden ‘Analysis and interpretation of data: Weinstein, ‘TTeteson, Le, A Testo, Hanscom, Sin, ‘od, tba, Deyo, ‘rating the mast Weinstein, T. Tostesn, ture Cita! evn ofthe manus fr important in feletuat content. Wnt Totton, Lune, ‘Av Tosterom, Hanscom, Skinner, Abdu, Paibrnd, eden Bey ‘Stats aac Wein Tstesn, A Toston, Hanscom, Skier Cbtaned finding Wenstin T.Tsteon, A Tsteson. Administrative techie, or material support ‘Westin. Tstsen, Lure ‘Stuy supervision: Waist, T_Toseson, Lr Financial Discosures Westen reports ha ee Erin Chet ne hasbeen crs to Ute Heath Cre prececds te conte tote Fan. 2 fund for ehiden wth dais, nthe name tie

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