Comprehensive Nonsurgical Treatment Versus Self-directed Care to Improve Walking Ability in Lumbar Spinal Stenosis: A Randomized Trial

Abstract

Objectives: To compare the effectiveness of a comprehensive nonsurgical training program to a self-directed approach in improving walking ability in lumbar spinal stenosis (LSS).

Design: Randomized controlled trial.

Setting: Academic hospital outpatient clinic.

Participants: Participants (N=104) with neurogenic claudication and imaging confirmed LSS were randomized. The mean age was 70.6 years, 57% were women, 84% had leg symptoms for >12 months, and the mean maximum walking capacity was 328.7 m.

Interventions: A 6-week structured comprehensive training program or a 6-week self-directed program.

Main outcome measures: Continuous walking distance in meters measured by the Self-Paced Walk Test (SPWT) and proportion of participants achieving at least 30% improvement (minimally clinically important difference [MCID]) in the SPWT at 6 months. Secondary outcomes included the Zurich Claudication Questionnaire (ZCQ), Oswestry Disability Index (ODI), ODI walk score, and the Short-Form General Health Survey subscales.

Results: A total of 48 versus 51 participants who were randomized to comprehensive (n=51) or self-directed (n=53) treatment, respectively, received the intervention and 89% of the total study sample completed the study. At 6 months, the adjusted mean difference in walking distance from baseline was 421.0 m (95% confidence interval [95% CI], 181.4-660.6), favoring the comprehensive program and 82% of participants in the comprehensive group and 63% in the self-directed group achieved the MCID (adjusted relative risk, 1.3; 95% CI, 1.0-1.7; P=.03). Both primary treatment effects persisted at 12 months favoring the comprehensive program. At 6 months, the ODI walk score and at 12 months the ZCQ, Medical Outcomes Study 36-Item Short-Form Health Survey-physical function and -bodily pain scores showed greater improvements favoring the comprehensive program.

Conclusions: A comprehensive conservative program demonstrated superior, large, and sustained improvements in walking ability and can be a safe nonsurgical treatment option for patients with neurogenic claudication due to LSS.

Trial registration: ClinicalTrials.gov NCT02592642.

Keywords: Back; Conservative treatment; Randomized controlled trial; Rehabilitation; Spinal stenosis.