Foot Orthoses in the Treatment of Painful Hallux Valgus

Background: Hallux valgus is a common foot deformity that causes significant pain, limits function and negatively impacts health-related quality of life. Foot orthoses (FOs), whether custom-made or prefabricated, are often prescribed to alleviate symptoms and improve function. However, their clinical effectiveness in individuals with painful hallux valgus remains unclear. The primary objective of this trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial comparing three multifaceted interventions combining foot exercises and education with custom FOs, prefabricated FOs, or sham FOs in patients with painful hallux valgus.

Methods/design: This participant-blinded, superiority, randomized pilot feasibility trial with three parallel groups will be conducted in Trois-Rivières, Canada. Thirty-six participants with painful hallux valgus will be recruited from the Université du Québec à Trois-Rivières outpatient podiatry clinic and through social media advertisements. Participants will be randomized to receive custom, prefabricated, or sham FOs. All groups will also receive a program of foot exercises and education about their condition. Participants will be evaluated at baseline and at 6- and 12-weeks time points. The primary feasibility outcomes will include recruitment rate, conversion rate, retention rate, adherence to treatment, intervention credibility and expectancy, and use of cointerventions. Secondary efficacy outcomes will include foot pain and limitations (Foot Function Index; average and maximal daily pain), self-assessed clinical progress (Global Rating of Change), and health-related quality of life (EQ-5D-5L).

Discussion: This trial will determine the feasibility of conducting a full-scale randomized controlled trial comparing the efficacy of custom and prefabricated FOs in reducing pain and improving function in patients with a painful hallux valgus.

Inclusion criteria

• Aged 18 to 74 years;
• 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;
• Can walk without assistive devices (e.g., cane, walker);
• Are willing to wear shoes that accommodate their foot orthoses daily;
• Are willing to minimize the use of other interventions (e.g., pain medications, physical therapy) during the trial period.

Exclusion criteria

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