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Abstract Background Hallux valgus is a common and disabling condition. This randomised pilot and feasibility trial aims to determine the feasibility of conducting a fully‐powered parallel group randomised trial to evaluate the effectiveness of a multifaceted non‐surgical intervention for reducing pain associated with hallux valgus. Methods Twenty‐eight community‐dwelling women with painful hallux valgus will be randomised to receive either a multifaceted, non‐surgical intervention (footwear, foot orthoses, foot exercises, advice, and self‐management) or advice and self‐management alone. Outcome measures will be obtained at baseline, 4, 8 and 12 weeks. The primary outcome is feasibility, which will be evaluated according to demand, acceptability, adherence, adverse events, and retention rate. Limited efficacy testing will be conducted on secondary outcome measures including foot pain (the Manchester‐Oxford Foot Questionnaire), foot muscle strength (hand‐held dynamometry), general health‐related quality of life (the Short Form‐12), use of cointerventions, and participants' perception of overall treatment effect. Biomechanical testing will be conducted at baseline to evaluate the immediate effects of the footwear/orthotic intervention on pressure beneath the foot and on the medial aspect of the first metatarsophalangeal joint and hallux. Discussion This study will determine the feasibility of conducting a fully‐powered randomised trial of footwear, foot orthoses, foot exercises, advice and self‐management for relieving pain associated with hallux valgus and provide insights into potential mechanisms of effectiveness. Trial registration Australian and New Zealand Clinical Trial Registry (ACTRN12621000645853).

Abstract Background Hallux valgus is a common and disabling condition. This randomised pilot and feasibility trial aimed to determine the feasibility of conducting a parallel group randomised trial to evaluate the effectiveness of a nonsurgical intervention for reducing pain associated with hallux valgus. Methods Twenty‐eight community‐dwelling women with painful hallux valgus were randomised to receive either a multifaceted, nonsurgical intervention (footwear, foot orthoses, foot exercises, advice, and self‐management) or usual care (advice and self‐management alone). Outcome measures were obtained at baseline, 4, 8 and 12 weeks. The primary outcome was feasibility, evaluated according to demand (recruitment rate and conversion rate), acceptability, adherence, adverse events, and retention rate. Limited efficacy testing was conducted on secondary outcome measures including foot pain, foot muscle strength, general health‐related quality of life, use of cointerventions, and participants' perception of overall treatment effect. Results Between July 8, 2021, and April 22, 2022, we recruited and tested 28 participants (aged 44 to 80 years, mean 60.7, standard deviation 10.7). This period encompassed two COVID‐related stay‐at‐home orders (July 16 to July 27, and August 5 to October 21, 2021). The predetermined feasibility thresholds were met for retention rate, foot pain, mental health‐related quality of life, and use of cointerventions, partly met for acceptability, adverse events, and muscle strength, and not met for demand (recruitment rate or conversion rate), adherence, physical health‐related quality of life and perception of overall treatment effect. Conclusion In its current form, a randomised trial of footwear, foot orthoses, foot exercises, advice and self‐management for relieving pain associated with hallux valgus is not feasible, particularly due to the low adherence with the intervention. However, it is difficult to determine whether the trial would be feasible under different circumstances, particularly due to COVID‐19 stay‐at‐home orders. Future trials will need to consider improving the aesthetics of the footwear and making the exercise program less burdensome. Trial registration Australian and New Zealand Clinical Trial Registry (ACTRN12621000645853).