Foot Orthoses in the Treatment of Painful Hallux Valgus

This randomized pilot feasibility trial will evaluate the feasibility of conducting a full-scale randomized controlled trial comparing custom-made, prefabricated, and sham foot orthoses in people with painful hallux valgus. All participants will also receive a standardized program of foot exercises and education. Thirty-six participants will be randomized to one of the three intervention groups and assessed at baseline, 6 weeks, and 12 weeks. The primary outcomes will assess the feasibility of recruitment, retention, treatment adherence, intervention credibility and expectancy, and use of cointerventions. Secondary outcomes will assess foot pain and function, perceived clinical improvement, and health-related quality of life. The findings will inform the design and conduct of a future full-scale randomized controlled trial.