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Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial.

ABSTRACT: Lumbar diskectomy is the most common surgical procedure performed for back and leg symptoms in US patients, but the efficacy of the procedure relative to nonoperative care remains controversial.To assess the efficacy of surgery for lumbar intervertebral disk herniation.The Spine Patient Outcomes Research Trial, a randomized clinical trial enrolling patients between March 2000 and November 2004 from 13 multidisciplinary spine clinics in 11 US states. Patients were 501 surgical candidates (mean age, 42 years; 42% women) with imaging-confirmed lumbar intervertebral disk herniation and persistent signs and symptoms of radiculopathy for at least 6 weeks.Standard open diskectomy vs nonoperative treatment individualized to the patient.Primary outcomes were changes from baseline for the Medical Outcomes Study 36-item Short-Form Health Survey bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons MODEMS version) at 6 weeks, 3 months, 6 months, and 1 and 2 years from enrollment. Secondary outcomes included sciatica severity as measured by the Sciatica Bothersomeness Index, satisfaction with symptoms, self-reported improvement, and employment status.Adherence to assigned treatment was limited: 50% of patients assigned to surgery received surgery within 3 months of enrollment, while 30% of those assigned to nonoperative treatment received surgery in the same period. Intent-to-treat analyses demonstrated substantial improvements for all primary and secondary outcomes in both treatment groups. Between-group differences in improvements were consistently in favor of surgery for all periods but were small and not statistically significant for the primary outcomes.Patients in both the surgery and the nonoperative treatment groups improved substantially over a 2-year period. Because of the large 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.clinicaltrials.gov Identifier: NCT00000410.

SUBMITTER: Weinstein JN

PROVIDER: S-EPMC2553805 | biostudies-literature | 2006 Nov

REPOSITORIES: biostudies-literature

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Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial.

Weinstein James N JN Tosteson Tor D TD Lurie Jon D JD Tosteson Anna N A AN Hanscom Brett B Skinner Jonathan S JS Abdu William A WA Hilibrand Alan S AS Boden Scott D SD Deyo Richard A RA

JAMA 20061101 20

<h4>Context</h4>Lumbar diskectomy is the most common surgical procedure performed for back and leg symptoms in US patients, but the efficacy of the procedure relative to nonoperative care remains controversial.<h4>Objective</h4>To assess the efficacy of surgery for lumbar intervertebral disk herniation.<h4>Design, setting, and patients</h4>The Spine Patient Outcomes Research Trial, a randomized clinical trial enrolling patients between March 2000 and November 2004 from 13 multidisciplinary spine ...[more]

PMID: 17119140

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Project description:ContextFor patients with lumbar disk herniation, the Spine Patient Outcomes Research Trial (SPORT) randomized trial intent-to-treat analysis showed small but not statistically significant differences in favor of diskectomy compared with usual care. However, the large numbers of patients who crossed over between assigned groups precluded any conclusions about the comparative effectiveness of operative therapy vs usual care.ObjectiveTo compare the treatment effects of diskectomy and usual care.Design, setting, and patientsProspective observational cohort of surgical candidates with imaging-confirmed lumbar intervertebral disk herniation who were treated at 13 spine clinics in 11 US states and who met the SPORT eligibility criteria but declined randomization between March 2000 and March 2003.InterventionsStandard open diskectomy vs usual nonoperative care.Main outcome measuresChanges from baseline in the Medical Outcomes Study Short-Form Health Survey (SF-36) bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons/MODEMS version).ResultsOf the 743 patients enrolled in the observational cohort, 528 patients received surgery and 191 received usual nonoperative care. At 3 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 2 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).ConclusionsPatients with persistent sciatica from lumbar disk herniation improved in both operated and usual care groups. Those who chose operative intervention reported greater improvements than patients who elected nonoperative care. However, nonrandomized comparisons of self-reported outcomes are subject to potential confounding and must be interpreted cautiously.Trial registrationclinicaltrials.gov Identifier: NCT00000410.

Project description:The management of degenerative spondylolisthesis associated with spinal stenosis remains controversial. Surgery is widely used and has recently been shown to be more effective than nonoperative treatment when the results were followed over two years. Questions remain regarding the long-term effects of surgical treatment compared with those of nonoperative treatment.Surgical candidates from thirteen centers with symptoms of at least twelve weeks' duration as well as confirmatory imaging showing degenerative spondylolisthesis with spinal stenosis were offered enrollment in a randomized cohort or observational cohort. Treatment consisted of standard decompressive laminectomy (with or without fusion) or usual nonoperative care. Primary outcome measures were the Short Form-36 (SF-36) bodily pain and physical function scores and the modified Oswestry Disability Index at six weeks, three months, six months, and yearly up to four years.In the randomized cohort (304 patients enrolled), 66% of those randomized to receive surgery received it by four years whereas 54% of those randomized to receive nonoperative care received surgery by four years. In the observational cohort (303 patients enrolled), 97% of those who chose surgery received it whereas 33% of those who chose nonoperative care eventually received surgery. The intent-to-treat analysis of the randomized cohort, which was limited by nonadherence to the assigned treatment, showed no significant differences in treatment outcomes between the operative and nonoperative groups at three or four years. An as-treated analysis combining the randomized and observational cohorts that adjusted for potential confounders demonstrated that the clinically relevant advantages of surgery that had been previously reported through two years were maintained at four years, with treatment effects of 15.3 (95% confidence interval, 11 to 19.7) for bodily pain, 18.9 (95% confidence interval, 14.8 to 23) for physical function, and -14.3 (95% confidence interval, -17.5 to -11.1) for the Oswestry Disability Index. Early advantages (at two years) of surgical treatment in terms of the secondary measures of bothersomeness of back and leg symptoms, overall satisfaction with current symptoms, and self-rated progress were also maintained at four years.Compared with patients who are treated nonoperatively, patients in whom degenerative spondylolisthesis and associated spinal stenosis are treated surgically maintain substantially greater pain relief and improvement in function for four years.

Project description:The purpose of the present study was to determine if the duration of symptoms affects outcomes following the treatment of intervertebral lumbar disc herniation.An as-treated analysis was performed on patients enrolled in the Spine Patient Outcomes Research Trial (SPORT) for the treatment of intervertebral lumbar disc herniation. Randomized and observational cohorts were combined. A comparison was made between patients who had had symptoms for six months or less (n = 927) and those who had had symptoms for more than six months (n = 265). Primary and secondary outcomes were measured at baseline and at regular follow-up intervals up to four years. The treatment effect for each outcome measure was determined at each follow-up period for the duration of symptoms for both groups.At all follow-up intervals, the primary outcome measures were significantly worse in patients who had had symptoms for more than six months prior to treatment, regardless of whether the treatment was operative or nonoperative. When the values at the time of the four-year follow-up were compared with the baseline values, patients in the operative treatment group who had had symptoms for six months or less had a greater increase in the bodily pain domain of the Short Form-36 (SF-36) (mean change, 48.3 compared with 41.9; p < 0.001), a greater increase in the physical function domain of the SF-36 (mean change, 47.7 compared with 41.2; p < 0.001), and a greater decrease in the Oswestry Disability Index score (mean change, -41.1 compared with -34.6; p < 0.001) as compared with those who had had symptoms for more than six months (with higher scores indicating less severe symptoms on the SF-36 and indicating more severe symptoms on the Oswestry Disability Index). When the values at the time of the four-year follow-up were compared with the baseline values, patients in the nonoperative treatment group who had had symptoms for six months or less had a greater increase in the bodily pain domain of the SF-36 (mean change, 31.8 compared with 21.4; p < 0.001), a greater increase in the physical function domain of the SF-36 (mean change, 29.5 compared with 22.6; p = 0.015), and a greater decrease in the Oswestry Disability Index score (mean change, -24.9 compared with -18.5; p = 0.006) as compared with those who had had symptoms for more than six months. Differences in treatment effect between the two groups related to the duration of symptoms were not significant.Increased symptom duration due to lumbar disc herniation is related to worse outcomes following both operative and nonoperative treatment. The relative increased benefit of surgery compared with nonoperative treatment was not dependent on the duration of the symptoms.

Project description:BackgroundQuestions remain as to the effect that obesity has on patients managed for symptomatic lumbar disc herniation. The purpose of this study was to determine if obesity affects outcomes following the treatment of symptomatic lumbar disc herniation.MethodsAn as-treated analysis was performed on patients enrolled in the Spine Patient Outcomes Research Trial for the treatment of lumbar disc herniation. A comparison was made between patients with a body mass index of <30 kg/m² (nonobese) (n = 854) and those with a body mass index of ≥30 kg/m² (obese) (n = 336). Baseline patient demographic and clinical characteristics were documented. Primary and secondary outcomes were measured at baseline and at regular follow-up time intervals up to four years. The difference in improvement from baseline between operative and nonoperative treatment was determined at each follow-up period for both groups.ResultsAt the time of the four-year follow-up evaluation, improvements over baseline in primary outcome measures were significantly less for obese patients as compared with nonobese patients in both the operative treatment group (Short Form-36 physical function, 37.3 compared with 47.7 points [p < 0.001], Short Form-36 bodily pain, 44.2 compared with 50.0 points [p = 0.005], and Oswestry Disability Index, -33.7 compared with -40.1 points [p < 0.001]) and the nonoperative treatment group (Short Form-36 physical function, 23.1 compared with 32.0 points [p < 0.001] and Oswestry Disability Index, -21.4 compared with -26.1 points [p < 0.001]). The one exception was that the change from baseline in terms of the Short Form-36 bodily pain score was statistically similar for obese and nonobese patients in the nonoperative treatment group (30.9 compared with 33.4 points [p = 0.39]). At the time of the four-year follow-up evaluation, when compared with nonobese patients who had been managed operatively, obese patients who had been managed operatively had significantly less improvement in the Sciatica Bothersomeness Index and the Low Back Pain Bothersomeness Index, but had no significant difference in patient satisfaction or self-rated improvement. In the present study, 77.5% of obese patients and 86.9% of nonobese patients who had been managed operatively were working a full or part-time job. No significant differences were observed in the secondary outcome measures between obese and nonobese patients who had been managed nonoperatively. The benefit of surgery over nonoperative treatment was not affected by body mass index.ConclusionsObese patients realized less clinical benefit from both operative and nonoperative treatment of lumbar disc herniation. Surgery provided similar benefit over nonoperative treatment in obese and nonobese patients.

Project description:BackgroundThe Spine Patient Outcomes Research Trial showed an overall advantage for operative compared with nonoperative treatment of lumbar disc herniations. Because a recent randomized trial showed no benefit for operative treatment of a disc at the lumbosacral junction (L5-S1), we reviewed subgroups within the Spine Patient Outcomes Research Trial to assess the effect of herniation level on outcomes of operative and nonoperative care.MethodsThe combined randomized and observation cohorts of the Spine Patient Outcomes Research Trial were analyzed by actual treatment received stratified by level of disc herniation. Overall, 646 L5-S1 herniations, 456 L4-L5 herniations, and eighty-eight upper lumbar (L2-L3 or L3-L4) herniations were evaluated. Primary outcome measures were the Short Form-36 bodily pain and physical functioning scales and the modified Oswestry Disability Index assessed at six weeks, three months, six months, one year, and two years. Treatment effects (the improvement in the operative group minus the improvement in the nonoperative group) were estimated with use of longitudinal regression models, adjusting for important covariates.ResultsAt two years, patients with upper lumbar herniations (L2-L3 or L3-L4) showed a significantly greater treatment effect from surgery than did patients with L5-S1 herniations for all outcome measures: 24.6 and 7.1, respectively, for bodily pain (p = 0.002); 23.4 and 9.9 for Short Form-36 physical functioning (p = 0.014); and -19 and -10.3 for Oswestry Disability Index (p = 0.033). There was a trend toward greater treatment effect for surgery at L4-L5 compared with L5-S1, but this was significant only for the Short Form-36 physical functioning subscale (p = 0.006). Differences in treatment effects between the upper lumbar levels and L4-L5 were significant for Short Form-36 bodily pain only (p = 0.018).ConclusionsThe advantage of operative compared with nonoperative treatment varied by herniation level, with the smallest treatment effects at L5-S1, intermediate effects at L4-L5, and the largest effects at L2-L3 and L3-L4. This difference in effect was mainly a result of less improvement in patients with upper lumbar herniations after nonoperative treatment.

Dataset Information

Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial.

Publications

Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial.

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