A Multicenter, Superiority Randomized Controlled Trial of Three Interventions for Patients With a Progressive Collapsing Foot Deformity

Starting soon · Not applicable · Has a placebo group

Conditions studied: Progressive Collapsing Foot Deformity

In brief

Background Progressive collapsing foot deformity (PCFD) is a painful musculoskeletal disorder leading to a progressively developing flat foot, which affects mobility and function and negatively impairs quality of life. Foot orthoses (FOs) are often prescribed to attenuate pain and improve function in patients with PCFD. However, no study has yet investigated the impact of adding FOs, whether custom (CFOs) or prefabricated (PFOs), to the usual treatment for PCFD. Thus, the primary objective of this trial will be to compare three different non-surgical interventions combining foot exercises and education with either CFOs, PFOs or sham FOs (SFOs). Methods/Design This participant-blinded multicentric superiority randomized controlled trial with three parallel groups will be conducted at the Université du Québec à Trois Rivières (UQTR) and the Center for Interdisciplinary Research in Rehabilitation and Social Integration (Cirris) in Canada. One hundred and ninety-eight participants with PCFD will be recruited via referral from physiotherapy and podiatry clinics and targeted advertising on social media. Participants will be randomized to receive CFOs, PFOs or SFOs. All groups will also receive a foot and ankle exercises program and education about their condition. They will be evaluated at four time points: baseline, 12 weeks, 24 weeks and 52 weeks. The primary outcome will be the subcategories of pain from the Foot Function Index (FFI) questionnaire. The secondary outcomes will be: foot pain and limitations (other categories of FFI, mean and maximal pain during walking for the most painful foot during the past week), self-assessed clinical progress (Global Rating Of Change), health-related quality of life (5-Level EQ-5D), gait biomechanics, fear avoidance (Fear avoidance Scale), supination resistance and ankle and hip endurance and force. Discussion This trial first aims to determine whether FOs treatment is effective, and second, whether one of the three FO interventions is more effective than the others. This trial will help guide FOs prescription recommendations for managing foot pain, function, and biomechanical outcomes in individuals with PCFD in the future.

Key facts

Study ID: NCT07756372
Run by: Université du Québec à Trois-Rivières
People needed: 198
Starts: 2027-01-01
Expected to finish: 2030-12-01
Last updated by the study team: 2026-08-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Present with PCFD according to Myerson et al. (M. S. Myerson et al., 2020) classification
Report medial ankle or foot pain lasting six weeks or more with a pain score of ≥ 3 out of 10 on a Visual Analogue Scale (VAS) and pain to the posterior tibial tendon
Are aged 18 to 70 years,
Can walk without assistive devices (e.g., cane, walker),
Are willing to wear shoes that accommodate their FOs daily,
Are willing to minimize the use of other interventions (e.g., pain medications, physical therapy) during the trial period.
Obtain a positive result on the single and/or double heel rise test (important pain during the test or inability to perform the test).

You may not qualify if…

Are classified as having Stage II rigid deformities according to Myerson classification,
Have a history of musculoskeletal surgery to the foot and ankle,
Present cognitive impairment,
Are currently pregnant or breastfeeding,
Have worn FOs within the past year.

Where it is running

Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris) — Québec, Quebec, Canada
Université du Québec à Trois-Rivières — Trois-Rivières, Quebec, Canada

Full record on ClinicalTrials.gov

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