medwireNews: Wearing individually calibrated biomechanical footwear for 24 weeks results in a statistically significant reduction in knee pain among people with osteoarthritis (OA), suggest results from the BIOTOK trial published in JAMA.
However, Peter Jüni (St Michael’s Hospital, Toronto, Ontario, Canada) and co-investigators say that the benefit “was of uncertain clinical importance, and further research is needed to assess long-term efficacy and safety.”
The trial included 220 individuals with symptomatic knee OA who were randomly assigned to wear the biomechanical footwear – involving shoes with two adjustable convex pods on the outsoles at the heel and forefoot – or to wear control footwear that had a similar appearance but did not create a convex walking surface. Participants were advised to wear the footwear indoors for half an hour per day for 1 week, followed by increases of 10 minutes per week on average and outdoor walking after week 6. Patients attended follow-up visits every 4 weeks during the study.
Average WOMAC pain score improved from 4.3 points at baseline to 1.3 points at the 24-week follow-up among the 111 patients in the biomechanical footwear group, and from 4.0 to 2.6 points among the 109 individuals wearing the control footwear.
These results translated into a statistically significant between-group difference of 1.3 points favoring the biomechanical footwear, and results “were consistent” for the secondary outcomes of WOMAC global, physical function, and stiffness scores, say Jüni et al.
However, they caution that “the between-group differences occurred only late during follow-up and were smaller than the observed within-group change from baseline in the control group,” indicating the uncertain clinical relevance of the findings.
“Further research would be needed […] before reaching conclusions about the clinical value of this device,” the team adds.
In all, 23.4% of participants in the biomechanical footwear group and 34.9% of those in the control group experienced adverse events, most commonly musculoskeletal events (13.5 vs 19.3%) including low-back pain (4.5 vs 4.5%), hip pain (4.5 vs 2.8%), foot pain (1.8 vs 2.8%), and knee pain or swelling (1.8 vs 2.8%). None of the adverse events were considered to be treatment-related.
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