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Surgical versus nonoperative treatment for lumbar disc herniation: four-year results for the Spine Patient Outcomes Research Trial (SPORT) [with consumer summary]
Weinstein JN, Lurie JD, Tosteson TD, Tosteson ANA, Blood EA, Abdu WA, Herkowitz H, Hilibrand A, Albert T, Fischgrund J
Spine 2008 Dec 1;33(25):2789-2800
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

STUDY DESIGN: Concurrent, prospective, randomized, and observational cohort study. OBJECTIVE: To assess the 4-year outcomes of surgery versus nonoperative care. SUMMARY OF BACKGROUND DATA: Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical to nonoperative treatment remain controversial. METHODS: Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting SPORT eligibility criteria enrolled into prospective, randomized (501 participants), and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual nonoperative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the modified Oswestry Disability Index (ODI AAOS/Modems version) assessed at 6 weeks, 3 months, 6 months, and annually thereafter. RESULTS: Nonadherence to treatment assignment caused the intent-to-treat analyses to underestimate the treatment effects. In the 4-year combined as-treated analysis, those receiving surgery demonstrated significantly greater improvement in all the primary outcome measures (mean change surgery versus nonoperative; treatment effect; 95% CI): BP (45.6 versus 30.7; 15.0; 11.8 to 18.1), PF (44.6 versus 29.7; 14.9;12.0 to 17.8) and ODI (-38.1 versus -24.9; -13.2; -15.6 to -10.9). The percent working was similar between the surgery and nonoperative groups, 84.4% versus 78.4% respectively. CONCLUSION: In a combined as-treated analysis at 4 years, patients who underwent surgery for a lumbar disc herniation achieved greater improvement than nonoperatively treated patients in all primary and secondary outcomes except work status. TRIAL REGISTRATION: Spine Patient Outcomes Research Trial (SPORT): intervertebral disc herniation; NCT00000410; http://www.ClinicalTrials.gov/ct/show/NCT00000410?order=2.
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