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Comprehensive non-surgical treatment versus self-directed care to improve walking ability in lumbar spinal stenosis: a randomized trial [with consumer summary]
Ammendolia C, Cote P, Southerst D, Schneider M, Budgell B, Bombardier C, Hawker G, Rampersaud YR
Archives of Physical Medicine and Rehabilitation 2018 Dec;99(12):2408-2419
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*

OBJECTIVES: To compare the effectiveness of a comprehensive non-surgical training program to a self-directed approach in improving walking ability in lumbar spinal stenosis. DESIGN: Randomized controlled trial. SETTING: Academic hospital outpatient clinic. PARTICIPANTS: A total of 104 participants with neurogenic claudication and imaging confirmed LSS were randomized. The mean age was 70.6 years, 57% were female, 84% had leg symptoms for more than 12-months and the mean maximum walking capacity was 328.7m. INTERVENTIONS: A six-week structured comprehensive training program or a six-week self-directed program. MAIN OUTCOME MEASURES: Continuous walking distance in meters (m) measured by the Self-Paced Walk Test (SPWT) and proportion of participants achieving at least 30% improvement (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 (SF-36) subscales. RESULTS: Forty-eight verses 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 421.0m (95% confidence interval (CI) 181.4 to 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 (RR) 1.3; 95% CI 1.0 to1.7; p = 0.03). 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, SF-36 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 non-surgical treatment option for patients with neurogenic claudication due to LSS.

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