Effect of biomechanical footwear on knee pain in people with knee osteoarthritis : the BIOTOK randomized clinical trial

Reichenbach, S, Felson, DT, Hincapié, CA, Heldner, S, Bütikofer, L, Lenz, A, da Costa, BR, Bonel, HM, Jones, RK ORCID: https://orcid.org/0000-0001-5242-185X, Hawker, GA and Jüni, P 2020, 'Effect of biomechanical footwear on knee pain in people with knee osteoarthritis : the BIOTOK randomized clinical trial' , The Journal of the American Medical Association (JAMA), 323 (18) , pp. 1802-1812.

[img] PDF - Accepted Version
Restricted to Repository staff only until 12 November 2020.

Download (400kB) | Request a copy

Abstract

Importance: 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. Objective: To assess the effect of a biomechanical footwear therapy vs control footwear over 24 weeks of follow-up. Design, Setting, and Participants: 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. Interventions: 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. Main Outcomes and Measures: 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. Results: 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. Conclusions and Relevance: 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.

Item Type: Article
Schools: Schools > School of Health and Society > Centre for Health Sciences Research
Journal or Publication Title: The Journal of the American Medical Association (JAMA)
Publisher: American Medical Association
ISSN: 0098-7484
Related URLs:
Funders: Maxi Foundation
Depositing User: Prof Richard Jones
Date Deposited: 13 May 2020 12:47
Last Modified: 27 May 2020 09:30
URI: http://usir.salford.ac.uk/id/eprint/57039

Actions (login required)

Edit record (repository staff only) Edit record (repository staff only)

Downloads

Downloads per month over past year