Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial
Stephan Reichenbach, David T Felson, Cesar A Hincapié, Sarah Heldner, Lukas Bütikofer, Armando Lenz, Bruno R da Costa, Harald M Bonel, Richard K Jones, Gillian A Hawker, Peter Jüni, Stephan Reichenbach, David T Felson, Cesar A Hincapié, Sarah Heldner, Lukas Bütikofer, Armando Lenz, Bruno R da Costa, Harald M Bonel, Richard K Jones, Gillian A Hawker, Peter Jüni
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.
Trial registration: ClinicalTrials.gov Identifier: NCT02363712.
Conflict of interest statement
Conflict of Interest Disclosures: Dr Jüni reported receiving grants from AstraZeneca, Biotronik, Biosensors, St Jude Medical, the Medicines Company, and the Canadian Institutes of Health Research; receiving honoraria from Amgen and Fresenius paid directly to his institution for participation on advisory boards; and serving as an unpaid member on steering committees for cardiovascular trials funded by AstraZeneca, Biotronik, Biosensors, St Jude Medical, and the Medicines Company. No other disclosures were reported.
Figures
![Figure 1.. Participant Recruitment, Randomization, and Follow-up](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/7218497/bin/jama-323-1802-g001.jpg)
![Figure 2.. Western Ontario and McMaster Universities…](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/7218497/bin/jama-323-1802-g002.jpg)
Source: PubMed