¹Institute for Social and Preventive Medicine, University of Bern, Bern, Switzerland
²Department of Rheumatology, Immunology, and Allergology, Bern University Hospital, Bern, Switzerland
³Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, England
⁴NIHR Manchester Musculoskeletal Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, England
⁵Clinical Epidemiology Unit, Boston University, Boston, Massachusetts
⁶Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael’s Hospital, Toronto, Ontario, Canada
⁷Department of Chiropractic Medicine, Faculty of Medicine, University of Zurich and Balgrist University Hospital, Zurich, Switzerland
⁸Clinical Trials Unit, University of Bern, Bern, Switzerland
⁹Department of Medicine and Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada
¹⁰Department for Diagnostic, Interventional, and Pediatric Radiology, Bern University Hospital, Bern, Switzerland
¹¹Centre for Health Sciences Research, School of Health Sciences, University of Salford Manchester, Manchester, England

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Key Points

Question Is an individualized biomechanical footwear therapy effective for reducing knee pain in people with knee osteoarthritis?

Findings In this randomized clinical trial that included 220 participants with knee pain due to knee osteoarthritis, treatment with an individualized biomechanical footwear therapy compared with control footwear resulted in a lower Western Ontario and McMaster Universities Osteoarthritis Index pain subscore (range, 0-10) after 24 weeks of follow-up (1.3 vs 2.6, respectively), a difference that was statistically significant.

Meaning Although use of biomechanical footwear compared with control footwear resulted in an improvement in knee pain at 24 weeks of follow-up that was statistically significant, the difference was of uncertain clinical importance, and further research is needed to assess long-term efficacy and safety.

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

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Article Information

Corresponding Author: Peter Jüni MD, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael’s Hospital, 250 Yonge St, Toronto, ON M5B 2L7, Canada (peter.juni@utoronto.ca).

Accepted for Publication: March 3, 2020.

Author Contributions: Drs Reichenbach and Jüni had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Reichenbach, Felson, da Costa, Jones, Jüni.

Acquisition, analysis, or interpretation of data: Reichenbach, Felson, Hincapié, Heldner, Bütikofer, Lenz, da Costa, Bonel, Hawker, Jüni.

Drafting of the manuscript: Reichenbach, Felson, Hincapié, Jüni.

Critical revision of the manuscript for important intellectual content: Reichenbach, Hincapié, Heldner, Bütikofer, Lenz, da Costa, Bonel, Jones, Hawker, Jüni.

Statistical analysis: Bütikofer, Lenz, da Costa, Jüni.

Obtained funding: Jüni.

Administrative, technical, or material support: Felson, Heldner, da Costa, Jones, Jüni.

Supervision: Reichenbach, Felson, Bonel, Jüni.

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.

Funding/Support: The trial was sponsored by Bern University Hospital and coordinated by CTU Bern, the University of Bern’s clinical trials unit. The trial was funded by the Mäxi Foundation. Dr Jüni is a tier 1 Canadian research chair in clinical epidemiology of chronic diseases; this research was completed, in part, with funding from the Canada Research Chairs Programme. Apos Medical Assets provided the biomechanical footwear system and the control footwear, and provided the technicians trained to install and calibrate the external pods on the biomechanical footwear without charge.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Additional Contributions: We thank the participants who participated in this trial. We acknowledge Avi Elbaz, MD, and Amit Mor, MD, for their contributions in the development of the control footwear; both were paid members of the board of AposTherapy Israel. We thank Madeleine Dähler and Zina Heg, MSc, for their contributions to data collection. At the time of data collection, both were paid staff members at CTU Bern and their salaries were funded by the Mäxi Foundation.

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