Foot Orthoses in the Treatment of Painful Hallux Valgus

Randomized Pilot Feasibility Trial on the Clinical Effects of Custom and Prefabricated Foot Orthoses in Patients With 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.

Inclusion Criteria:

1. Aged 18 to 74 years;
2. Have unilateral or bilateral hallux valgus (Manchester scale ≥ 2) with pain for at least 3 months (average pain score ≥ 3 out of 10 on a Visual Analogue Scale (VAS)) that is aggravated by weight-bearing activities. If participants have bilateral hallux valgus, the most painful foot will be used for data collection. Participants with pain secondary to friction between the first metatarsophalangeal joint and the shoe will be excluded unless the intra-articular or plantar pain is more significant;
3. Can walk without assistive devices (e.g., cane, walker);
4. Are willing to wear shoes that accommodate their foot orthoses daily;
5. Are willing to minimize the use of other interventions (e.g., pain medications, physical therapy) during the trial period.

Exclusion Criteria:

1. Inflammatory conditions (e.g., arthritis, gout), neurological diseases and other sources of mechanical foot pain;
2. History of orthopedic foot surgery;
3. Prior use of custom or prefabricated foot orthoses in the past 12 weeks;
4. Cognitive impairment;
5. Currently pregnant or breastfeeding;
6. Participation in foot exercises within the past 12 weeks;
7. Less than 10 degrees range of motion at the first metatarsophalangeal joint.