Carlo Ammendolia1, Pierre Côté2, Danielle Southerst3, Michael Schneider4, Brian Budgell5, Claire Bombardier6, Gillian Hawker6, Y Raja Rampersaud7. 1. Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Rebecca MacDonald Centre for Arthritis & Autoimmune Disease, Mount Sinai Hospital, Toronto, Ontario, Canada. Electronic address: cammendolia@mtsinai.on.ca. 2. Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada; Faculty of Health Sciences, University of Ontario Institute of Technology and UOIT-CMCC Centre for Disability Prevention and Rehabilitation, Toronto, Ontario, Canada. 3. Occupational and Industrial Orthopaedic Centre, Department of Orthopaedic Surgery, NYU Langone Health, New York, NY. 4. Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA. 5. Canadian Memorial Chiropractic College, Toronto, Ontario, Canada. 6. Department of Medicine, Division of Rheumatology, University of Toronto, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada. 7. Department of Orthopedics, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada.
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.
RCT Entities:
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.
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Authors: Carlo Ammendolia; Corey Hofkirchner; Joshua Plener; André Bussières; Michael J Schneider; James J Young; Andrea D Furlan; Kent Stuber; Aksa Ahmed; Carol Cancelliere; Aleisha Adeboyejo; Joseph Ornelas Journal: BMJ Open Date: 2022-01-19 Impact factor: 2.692