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AbstractContext 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.Objective To assess the efficacy of surgery for lumbar intervertebral disk herniation.Design, Setting, and Patients 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. Lumbar diskectomy is the most common surgical procedure performed in the United States for patients having back and leg symptoms; the vast majority of the procedures are elective. However, lumbar disk herniation is often seen on imaging studies in the absence of symptoms, and can regress over time without surgery.

Up to 15-fold variation in regional diskectomy rates in the United States and lower rates internationally raise questions regarding the appropriateness of some of these surgeries.,Several studies have compared surgical and nonoperative treatment of patients with herniated disk, but baseline differences between treatment groups, small sample sizes, or lack of validated outcome measures in these studies limit evidence-based conclusions regarding optimal treatment. The Spine Patient Outcomes Research Trial (SPORT) was initiated in March 2000 to compare the outcomes of surgical and nonoperative treatment for lumbar intervertebral disk herniation, spinal stenosis, or degenerative spondylolisthesis. The trial included both a randomized cohort and an observational cohort who declined to be randomized in favor of designating their own treatment but otherwise met all the other criteria for inclusion and who agreed to undergo follow-up according to the same protocol. This article reports intent-to-treat results through 2 years for the randomized cohort. Patient PopulationPatients were considered for inclusion if they were 18 years and older and diagnosed by participating physicians during the study enrollment period as having intervertebral disk herniation and persistent symptoms despite some nonoperative treatment for at least 6 weeks. Study InterventionsThe surgery was a standard open diskectomy with examination of the involved nerve root., The procedure agreed on by all participating centers was performed under general or local anesthesia, with patients in the prone or knee-chest position. Surgeons were encouraged to use loupe magnification or a microscope.

Using a midline incision reflecting the paraspinous muscles, the interlaminar space was entered as described by Delamarter and McCullough. In some cases the medial border of the superior facet was removed to provide a clear view of the involved nerve root. Using a small annular incision, the fragment of disk was removed as described by Spengler. The canal was inspected and the foramen probed for residual disk or bony pathology. The nerve root was decompressed, leaving it freely mobile.The nonoperative treatment group received “usual care,” with the study protocol recommending that the minimum nonsurgical treatment include at least active physical therapy, education/counseling with home exercise instruction, and nonsteroidal anti-inflammatory drugs, if tolerated. Other nonoperative treatments were listed, and physicians were encouraged to individualize treatment to the patient; all nonoperative treatments were tracked prospectively.

Study MeasuresThe primary measures were the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) bodily pain and physical function scales - and the American Academy of Orthopaedic Surgeons MODEMS version of the Oswestry Disability Index (ODI). As specified in the trial protocol, the primary outcomes were changes from baseline in these scales at 6 weeks, 3 months, 6 months, and 1 and 2 years from enrollment.Secondary measures included patient self-reported improvement, work status, and satisfaction with current symptoms and with care. Symptom severity was measured by the Sciatica Bothersomeness Index (range, 0-24; higher scores represent worse symptoms). Recruitment, Enrollment, and RandomizationA research nurse at each site identified potential participants and verified eligibility. For recruitment and informed consent, evidence-based videotapes described the surgical and nonoperative treatments and the expected benefits, risks, and uncertainties., Participants were offered enrollment in either the randomized trial or a concurrent observational cohort, the results of which are reported in a companion article.Enrollment began in March 2000 and ended in November 2004. Baseline variables were collected prior to randomization. Patients self-reported race and ethnicity using National Institutes of Health categories.Computer-generated random treatment assignment based on permuted blocks (randomly generated blocks of 6, 8, 10, and 12) within sites occurred immediately after enrollment via an automated system at each site, ensuring proper allocation concealment.

Study measures were collected at baseline and at regularly scheduled follow-up visits. Short-term follow-up visits occurred at 6 weeks and 3 months. If surgery was delayed beyond 6 weeks, additional follow-up data were obtained 6 weeks and 3 months postoperatively.

Longer-term follow-up visits occurred at 6 months, 1 year from enrollment, and annually thereafter. Statistical AnalysesWe originally determined a sample size of 250 patients in each treatment group to be sufficient (with a 2-sided significance level of.05 and 85% power) to detect a 10-point difference in the SF-36 bodily pain and physical functioning scales or a similar effect size in the ODI. This difference corresponded to patients' reports of being “a little better” in the Maine Lumbar Spine Study (MLSS). The sample size calculation allowed for up to 20% missing data but did not account for any specific levels of nonadherence.The analyses for the primary and secondary outcomes used all available data for each period on an intent-to-treat basis. Predetermined end points for the study included results at each of 6 weeks, 3 months, 6 months, 1 year, and 2 years.

To adjust for the possible effect of missing data on the study results, the analysis of mean changes for continuous outcomes was performed using maximum likelihood estimation for longitudinal mixed-effects models under “missing at random” assumptions and including a term for treatment center. Comparative analyses were performed using the single imputation methods of baseline value carried forward and last value carried forward, as well as a longitudinal mixed model controlling for covariates associated with missed visits.For binary secondary outcomes, longitudinal logistic regression models were fitted using generalized estimating equations as implemented in the PROC GENMOD program of SAS version 9.1 (SAS Institute Inc, Cary, NC).

Treatment effects were estimated as differences in the estimated proportions in the 2 treatment groups.P. Nonoperative TreatmentsA variety of nonoperative treatments were used during the study.

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Most patients received education/counseling (93%) and anti-inflammatory medications (61%) (nonsteroidal anti-inflammatory drugs, cyclooxygenase 2 inhibitors, or oral steroids); 46% received opiates; more than 50% received injections (eg, epidural steroids); and 29% were prescribed activity restriction. Forty-four percent received active physical therapy during the trial; however, 67% had received it prior to enrollment. Surgical Treatment and Complicationsgives the characteristics of surgical treatment and complications. The median surgical time was 75 minutes (interquartile range, 58-90), with a median blood loss of 49.5 mL (interquartile range, 25-75). Only 2% required transfusions. There were no perioperative deaths; 1 patient died from complications of childbirth 11 months after enrollment.

The most common intraoperative complication was dural tear (4%). There were no postoperative complications in 95% of patients. Reoperation occurred in 4% of patients within 1 year of the initial surgery; more than 50% of the reoperations were for recurrent herniations at the same level. NonadherenceNonadherence to treatment assignment affected both groups, ie, some patients in the surgery group chose to delay or decline surgery, and some in the nonoperative treatment group crossed over to receive surgery. The characteristics of crossover patients that were statistically different from patients who did not cross over are shown in. Those more likely to cross over to receive surgery tended to have lower incomes, worse baseline symptoms, more baseline disability on the ODI, and were more likely to rate their symptoms as getting worse at enrollment than the other patients receiving nonoperative treatment.

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Those more likely to cross over to receive nonoperative care were older, had higher incomes, were more likely to have an upper lumbar disk herniation, less likely to have a positive straight leg–raising test result, had less pain, better physical function, less disability on the ODI, and were more likely to rate their symptoms as getting better at enrollment than the other surgery patients. Missing DataThe rates of missing data were equivalent between the groups at each time point, with no evidence of differential dropout according to assigned treatment. Characteristics of patients with missed visits were very similar to those of the rest of the cohort except that patients with missing data were less likely to be married, more likely to be receiving disability compensation, more likely to smoke, more likely to display baseline motor weakness, and had lower baseline mental component summary scores on the SF-36. Intent-to-Treat Analysesshows estimated mean changes from baseline and the treatment effects (differences in changes from baseline between treatment groups) for 3 months, 1 year, and 2 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.

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As shown in, 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. This test accounts for intraindividual correlations as described in the “Methods” section.For the secondary outcome of sciatica bothersomeness, and show that there were greater improvements in the Sciatica Bothersomeness Index in the surgery group at all designated follow-up times: 3 months (treatment effect, −2.1; 95% CI, −3.4 to −0.9), 1 year (treatment effect, −1.6; 95% CI, −2.9 to −0.4), and 2 years (treatment effect, −1.6; 95% CI, −2.9 to −0.3), with results of the global hypothesis test being statistically significant ( P =.003). Patient satisfaction with symptoms and treatment showed small effects in favor of surgery while employment status showed small effects in favor of nonoperative care, but none of these changes was statistically significant.

Self-rated progress showed a small statistically significant advantage for surgery ( P =.04).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 times through 2 years. For example, at 1 year the estimated treatment effects for the SF-36 bodily pain and physical function scales, the ODI, and the sciatica measures were 15.0 (95% CI, 10.9 to 19.2), 17.5 (95% CI, 13.6 to 21.5), −15.0 (95% CI, −18.3 to −11.7), and −3.2 (95% CI, −4.3 to −2.1), respectively.Sensitivity analysis was performed for 4 different analytic methods of dealing with the missing data. One method was based on simple mean changes for all patients with data at a given time point with no special adjustment for missing data. Two methods used single imputation methods—baseline value carried forward and last value carried forward. The latter method used the same mixed-models approach for estimating mean changes as given in but also adjusted for factors affecting the likelihood of missing data.

Treatment effect estimates at 1 year ranged from 1.6 to 2.9 for the SF-36 bodily pain scale, 0.74 to 1.4 for the physical function scale, −2.2 to −3.3 for the ODI, and −1.1 to −1.6 for the sciatica measures. Given these ranges, there appear to be no substantial differences between any of these methods. CommentBoth operated and nonoperated patients with intervertebral disk herniation improved substantially over a 2-year period. The intent-to-treat analysis in this trial showed no statistically significant treatment effects for the primary outcomes; the secondary measures of sciatica severity and self-reported progress did show statistically significant advantages for surgery. These results must be viewed in the context of the substantial rates of nonadherence to assigned treatment. The pattern of nonadherence is striking because, unlike many surgical studies, both the surgical and nonoperative treatment groups were affected.

The most comparable previous trial had 26% crossover into surgery at 1 year, but only 2% crossover out of surgery. The mixing of treatments due to crossover can be expected to create a bias toward the null. The large effects seen in the as-treated analysis and the characteristics of the crossover patients suggest that the intent-to-treat analysis underestimates the true effect of surgery.SPORT findings are consistent with clinical experience in that relief of leg pain was the most striking and consistent improvement with surgery. Importantly, all patients in this trial had leg pain with physical examination and imaging findings that confirmed a disk herniation.

There was little evidence of harm from either treatment. No patients in either group developed cauda equina syndrome; 95% of surgical patients had no intraoperative complications.

ConclusionPatients in both the surgery and nonoperative treatment groups improved substantially over the first 2 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. Article InformationCorresponding Author: James N.

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Weinstein, DO, MSc, Department of Orthopaedics, Dartmouth Medical School, One Medical Center Drive, Lebanon, NH 03756.Author Contributions: Dr Weinstein had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.Study concept and design: Weinstein, T. Tosteson, Lurie, A. Tosteson.Acquisition of data: Weinstein, T. Tosteson, Lurie, Abdu, Hilibrand, Boden.Analysis and interpretation of data: Weinstein, T. Tosteson, Lurie, A. Tosteson, Hanscom, Skinner, Abdu, Hilibrand, Deyo.Drafting of the manuscript: Weinstein, T.

Tosteson, Lurie.Critical revision of the manuscript for important intellectual content: Weinstein, T. Tosteson, Lurie, A.

Tosteson, Hanscom, Skinner, Abdu, Hilibrand, Boden, Deyo.Statistical analysis: Weinstein, T. Tosteson, Hanscom, Skinner.Obtained funding: Weinstein, T. Tosteson.Administrative, technical, or material support: Weinstein, T.

Tosteson, Lurie.Study supervision: Weinstein, T. Tosteson, Lurie. Financial Disclosures: Dr Weinstein reports that he is Editor-in-Chief of Spine, has been a consultant to United Health Care (proceeds are donated to the Brie Fund, a fund for children with disabilities, in the name of his daughter who passed away from leukemia), and has been a consultant to the Foundation for Informed Medical Decision Making, proceeds to the Department of Orthopaedics, Dartmouth. Dr Lurie reports that he receives grant support from St Francis Medical Technologies and American Board of Orthopaedic Surgery; has served on advisory boards for Ortho-MacNeil Pharmaceuticals, the Robert Graham Center of the American Academy of Family Practice, and Centocor; and as a consultant for Myexpertdoctor.com, Pacific Business Group on Health, and the Foundation for Informed Medical Decision Making. Tosteson reports receiving funding from St Francis Medical Technologies. Mr Hanscom reports working for the National Spine Network and receiving funding from Medtronic. Dr Boden reports serving as a consultant for Medtronic.

Dr Deyo reports receiving research program benefits as a gift to the University of Washington from Synthes, a manufacturer of surgical appliances, from which he receives no personal benefits. No other disclosures were reported.Funding/Support: This study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (U01-AR45444-01A1) and the Office of Research on Women's Health, National Institutes of Health; and by the National Institute of Occupational Safety and Health, US Centers for Disease Control and Prevention. The Multidisciplinary Clinical Research Center in Musculoskeletal Diseases is funded by NIAMS (P60-AR048094-01A1).

Dr Lurie is supported by a Research Career Award from NIAMS (1 K23 AR 048138-01).Role of the Sponsors: The funding sources had no role in design or conduct of the study; the collection, management, analysis, or interpretation of the data; or the preparation, review, or approval of the manuscript.Project Coordinator, Principal Investigators, Participating Institutions, and Nurse Coordinators (in order by enrollment): Judi L. Forman, MPH (Project Coordinator), William A. Abdu, MD, MS, Barbara Butler-Schmidt, RN, MSN, J.