Abstract
BACKGROUND: Midfoot osteoarthritis (OA) is more prevalent and strongly associated with pain than previously thought. Excessive mechanical loading of the midfoot structures may contribute to midfoot OA and studies suggest that functional foot orthoses (FFO) may relieve pain through improving function. This exploratory study aimed to evaluate the mechanical effect of two off-the-shelf FFOs, compared to a sham orthosis in people with midfoot OA. METHODS: Thirty-three participants with radiographically confirmed symptomatic midfoot OA were randomly assigned to wear either a commercially available FFO or a sham orthosis. After wearing their assigned orthoses for 12 weeks, plantar pressure measurements were obtained under shoe-only and assigned orthoses conditions. Participants assigned to the sham, were additionally tested wearing a second type of FFO at the end of trial. Descriptive mean change (±95% confidence intervals) in plantar pressure for each orthoses condition, versus a shoe only baseline condition are presented. FINDINGS: Compared to the shoe only conditions, both FFOs decreased hindfoot and forefoot maximum force and peak pressure, whilst increasing maximum force and contact area under the midfoot. The sham orthosis yielded plantar pressures similar to the shoe-only condition. INTERPRETATION: Findings suggest that both types of off-the-shelf FFO may provide mechanical benefit, whilst the sham orthoses produced similar findings to the shoe only condition, indicating appropriate sham properties. This paper provides insight into the mechanisms of action underpinning the use of FFOs and sham orthoses, which can inform future definitive RCTs examining the effect of orthoses on midfoot OA.