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.