Effect of motion control versus neutral walking footwear on pain associated with lateral tibiofemoral joint osteoarthritis: a comparative effectiveness randomised clinical trial

OBJECTIVES: To determine if motion control walking shoes are superior to neutral walking shoes in reducing knee pain on walking in people with lateral knee osteoarthritis (OA). DESIGN: Participant-blinded and assessor-blinded, comparative effectiveness, superiority randomised controlled trial. SETTING: Melbourne, Australia. PARTICIPANTS: People with symptomatic radiographic lateral tibiofemoral OA from the community and our volunteer database. INTERVENTION: Participants were randomised to receive either motion control or neutral shoes and advised to wear them >6 hours/day over 6 months. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was change in average knee pain on walking over the previous week (11-point Numeric Rating Scale (NRS), 0–10) at 6 months. The secondary outcomes included other measures of knee pain, physical function, quality of life, participant-perceived change in pain and function, and physical activity. RESULTS: We planned to recruit 110 participants (55 per arm) but ceased recruitment at 40 (n=18 motion control shoes, n=22 neutral shoes) due to COVID-19-related impacts. All 40 participants completed 6-month outcomes. There was no evidence that motion control shoes were superior to neutral shoes for the primary outcome of pain (mean between-group difference 0.4 NRS units, 95% CI −1.0 to 1.7) nor for any secondary outcome. The number of participants experiencing any adverse events was similar between groups (motion control shoes: n=5, 28%; neutral shoes: n=4, 18.2%) and were minor. CONCLUSIONS: Motion control shoes were not superior to neutral shoes in improving knee pain on walking in symptomatic radiographic lateral tibiofemoral joint OA. Further research is needed to identify effective treatments in this important but under-researched knee OA subgroup. TRIAL REGISTRATION NUMBER: ACTRN12618001864213.