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- Title
Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial.
- Authors
Reichenbach, Stephan; Felson, David T.; Hincapié, Cesar A.; Heldner, Sarah; Bütikofer, Lukas; Lenz, Armando; da Costa, Bruno R.; Bonel, Harald M.; Jones, Richard K.; Hawker, Gillian A.; Jüni, Peter
- Abstract
<bold>Importance: </bold>Individually calibrated biomechanical footwear therapy may improve pain and physical function in people with symptomatic knee osteoarthritis, but the benefits of this therapy are unclear.<bold>Objective: </bold>To assess the effect of a biomechanical footwear therapy vs control footwear over 24 weeks of follow-up.<bold>Design, Setting, and Participants: </bold>Randomized clinical trial conducted at a Swiss university hospital. Participants (N = 220) with symptomatic, radiologically confirmed knee osteoarthritis were recruited between April 20, 2015, and January 10, 2017. The last participant visit occurred on August 15, 2017.<bold>Interventions: </bold>Participants were randomized to biomechanical footwear involving shoes with individually adjustable external convex pods attached to the outsole (n = 111) or to control footwear (n = 109) that had visible outsole pods that were not adjustable and did not create a convex walking surface.<bold>Main Outcomes and Measures: </bold>The primary outcome was knee pain at 24 weeks of follow-up assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore standardized to range from 0 (no symptoms) to 10 (extreme symptoms). The secondary outcomes included WOMAC physical function and stiffness subscores and the WOMAC global score, all ranging from 0 (no symptoms) to 10 (extreme symptoms) at 24 weeks of follow-up, and serious adverse events.<bold>Results: </bold>Among the 220 randomized participants (mean age, 65.2 years [SD, 9.3 years]; 104 women [47.3%]), 219 received the allocated treatment and 213 (96.8%) completed follow-up. At 24 weeks of follow-up, the mean standardized WOMAC pain subscore improved from 4.3 to 1.3 in the biomechanical footwear group and from 4.0 to 2.6 in the control footwear group (between-group difference in scores at 24 weeks of follow-up, -1.3 [95% CI, -1.8 to -0.9]; P < .001). The results were consistent for WOMAC physical function subscore (between-group difference, -1.1 [95% CI, -1.5 to -0.7]), WOMAC stiffness subscore (between-group difference, -1.4 [95% CI, -1.9 to -0.9]), and WOMAC global score (between-group difference, -1.2 [95% CI, -1.6 to -0.8]) at 24 weeks of follow-up. Three serious adverse events occurred in the biomechanical footwear group compared with 9 in the control footwear group (2.7% vs 8.3%, respectively); none were related to treatment.<bold>Conclusions and Relevance: </bold>Among participants with knee pain from osteoarthritis, use of biomechanical footwear compared with control footwear resulted in an improvement in pain at 24 weeks of follow-up that was statistically significant but of uncertain clinical importance. Further research would be needed to assess long-term efficacy and safety, as well as replication, before reaching conclusions about the clinical value of this device.<bold>Trial Registration: </bold>ClinicalTrials.gov Identifier: NCT02363712.
- Subjects
KNEE pain; OSTEOARTHRITIS; PAIN management; BIOMECHANICS; FOOTWEAR; CLINICAL trials; OSTEOARTHRITIS treatment; KNEE diseases; RESEARCH; SHOES; PAIN; PAIN measurement; RESEARCH methodology; BIOMEDICAL engineering; EVALUATION research; MEDICAL cooperation; PRODUCT design; COMPARATIVE studies; RANDOMIZED controlled trials; QUALITY of life; KNEE; LONGITUDINAL method; KINEMATICS; DISEASE complications
- Publication
JAMA: Journal of the American Medical Association, 2020, Vol 323, Issue 18, p1802
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2020.3565