Surgical treatment for lumbar spinal stenosis: a single-blinded randomized controlled trial

Abstract

Objective: To evaluate the effectiveness of surgery for the management of patients with symptomatic lumbar spinal stenosis. Methods: Sixty-three patients with lumbar canal stenosis were randomized into two groups: the intervention group (IG) and control group (CG). IG patients underwent surgery and both groups participated in the same physical therapy program twice a week for a period of 12 weeks and were followed up at 1 year. The primary endpoint was visual analogue scale for pain, and the secondary endpoints were function (6-min walk test, Roland Morris and Oswestry questionnaires), quality of life (SF-36 questionnaire) and satisfaction with treatment (Likert scale). Results: No significant difference between groups was observed for pain over time (p = 0.145). Significant differences between groups, in favor of the IG, were observed for the Oswestry score (p = 0.006) and vitality domain score of the SF-36 (p = 0.047). Function in the Roland Morris and 6-min walk test and the role of the physical domain of SF-36 also showed significant differences between the groups; however, these differences occurred due to a worsening of the IG in the short term, and the medium-term. The Likert scale demonstrated greater satisfaction with the IG treatment compared to control group. Conclusions: Lumbar stenosis surgery did not improve pain in short and medium terms. Function and vitality were better in the group that underwent surgery in the medium term, and patients were more satisfied with the surgical treatment. Trial registration: Clinicaltrials.gov (NCT02879461).