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Surgery versus nonsurgical treatment of lumbar spinal stenosis: a randomized trial [with consumer summary] |
Delitto A, Piva SR, Moore CG, Fritz JM, Wisniewski SR, Josbeno DA, Fye M, Welch WC |
Annals of Internal Medicine 2015 Apr 7;162(7):465-473 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; 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* |
BACKGROUND: Primary care management decisions for patients with symptomatic lumbar spinal stenosis (LSS) are challenging, and nonsurgical guidance is limited by lack of evidence. OBJECTIVE: To compare surgical decompression with physical therapy (PT) for LSS and evaluate sex differences. DESIGN: Multisite randomized, controlled trial. (ClinicalTrials.gov NCT00022776). SETTING: Neurologic and orthopedic surgery departments and PT clinics. PARTICIPANTS: Surgical candidates with LSS aged 50 years or older who consented to surgery. INTERVENTION: Surgical decompression or PT. MEASUREMENTS: Primary outcome was physical function score on the Short Form-36 Health Survey at 2 years assessed by masked testers. RESULTS: The study took place from November 2000 to September 2007. A total of 169 participants were randomly assigned and stratified by surgeon and sex (87 to surgery and 82 to PT), with 24-month follow-up completed by 74 and 73 participants in the surgery and PT groups, respectively. Mean improvement in physical function for the surgery and PT groups was 22.4 (95% CI 16.9 to 27.9) and 19.2 (CI 13.6 to 24.8), respectively. Intention-to-treat analyses revealed no difference between groups (24-month difference 0.9 (CI -7.9 to 9.6)). Sensitivity analyses using causal-effects methods to account for the high proportion of crossovers from PT to surgery (57%) showed no significant differences in physical function between groups. LIMITATION: Without a control group, it is not possible to judge success attributable to either intervention. CONCLUSION: Surgical decompression yielded similar effects to a PT regimen among patients with LSS who were surgical candidates. Patients and health care providers should engage in shared decision-making conversations that include full disclosure of evidence involving surgical and nonsurgical treatments for LSS. PRIMARY FUNDING SOURCE: National Institutes of Health and National Institute of Arthritis and Musculoskeletal and Skin Diseases.
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