Discussion
pain
RECRUITMENT
The primary objective of this study was to evaluate the feasibility of conducting a randomised trial comparing a multifaceted nonsurgical intervention versus usual care for reducing pain associated with hallux valgus. This is the first study designed to explore the effects of these interventions when used in combination [Before discussing the findings in detail, it is worth outlining how COVID-19 may have affected the conduct of the trial. The first participant completed baseline testing on July 8, 2021, however, due to stay-at-home restrictions, recruitment and data collection were suspended from July 15 to 27 and from August 5 to October 21, 2021 (94 days in total) [In designing the original protocol for this study, we acknowledged that the most likely barrier to acceptability of the intervention would be aesthetic concerns regarding the footwear, as the shoes required an extra wide and deep toe box [Adherence was even lower for the exercise component of the study, with only 7% of the sample completing at least 75% of the exercise sessions according to the PhysiTrackInterestingly, we found very little association between objectively measured and self-reported adherence. For footwear and orthoses, we found that only 14% wore the devices for an average of ≥ 5 h per day (measured using a temperature sensor) [The findings of this study need to be interpreted in the context of its strengths and limitations. The study design had several key strengths, including randomisation, concealed allocation, and blinded analysis, and the reporting adheres to both the SPIRIT 2013 statement [