Surgery versus nonsurgical treatment of lumbar spinal stenosis: a randomized trial

Abstract

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.

Figure 1.

Stenosis Trial Flow Diagram.

Figure 2.. Adjusted Means for Physical Function over Time in the Surgery and Physical Therapy Groups.

Adjusted means and 95% confidence intervals of physical function scale of the Short Form-36 (SF-36) for the surgery and physical therapy groups over time from linear mixed models (adjusted for gender, surgeon and baseline age). SF-36 scale ranges from 0 to 100, with lower scores indicating more severe symptoms. PT stands for Physical Therapy.

Figure 3.. Adjusted Means for Physical Function over Time by Treatment and Gender using Intention to Treat Analyses.

Adjusted means of physical function scale of the Short Form-36 (SF-36) for the surgery (solid lines) and physical therapy (dashed lines) groups by gender (male = blue lines; female = red lines) over time from linear mixed models (adjusted for surgeon and baseline age). Three-way interaction for gender*group*time p=0.066; group*time within men p=0.10; group*time within women p=0.50. SF-36 scale ranges from 0 to 100, with lower scores indicating more severe symptoms. PT stands for Physical Therapy.