NCT06962475

Randomized Controlled Trial of Custom Foot Orthoses for Chronic Forefoot Pain

Recruiting now NA Last updated 10 February 2026

What this trial tests

NA trial testing Podiatric advice in Metatarsalgia in 64 participants. Currently enrolling.

Timeline

1 February 2025

Primary endpoint
1 August 2027

1 August 2027

Quick facts

Lead sponsor	Université du Québec à Trois-Rivières
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	64
Start date	1 February 2025
Primary completion	1 August 2027
Estimated completion	1 August 2027
Sites	1 location across Canada

Drugs / interventions tested

• Podiatric advice
• Customized foot orthoses
• Sham foot orthoses

Conditions studied

• Metatarsalgia — all drugs for Metatarsalgia →

Sponsor

Université du Québec à Trois-Rivières — full company profile →

Who can join

18 and older, any sex, with Metatarsalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background Chronic metatarsalgia (CM) causes significant pain and disability, affecting quality of life. Foot orthoses (FOs) including medially wedged designs with a metatarsal pad decrease excessive plantar pressure under the metatarsal heads, which is a suggested risk factor for developing CM. This FOs model may be effective in diminishing pain and improving function in these individuals. Thus, the objective of this trial will be to compare the effects of medially wedged FOs with a metatarsal pad and sham FOs on pain and foot function in individuals with CM.

Methods/design This participant- and assessor-blinded superiority randomized controlled trial (RCT) with two parallel groups will be conducted in Trois-Rivières, Canada. Sixty-four participants with CM will be recruited from the Université du Québec à Trois-Rivières outpatient podiatry clinic and via social media invitations. They will be randomized into intervention (customized FOs) or control (sham FOs) groups and will be evaluated at baseline and after 6 and 12 weeks. The primary outcome will be: (1) mean pain during walking for the most painful foot during the past week. The secondary outcomes will be: (1) Foot Function Index, (2) Global rating of change and (3) the 5-level EQ-5D.

Discussion Medially wedged FOs with a metatarsal pad are expected to provide a greater reduction in pain and improvement in foot function compared to sham FOs. This trial will help guide FOs prescription recommendations for managing foot pain in individuals with CM in the future.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Custom foot orthoses for chronic metatarsalgia: Study protocol for a participant- and assessor-blinded superiority randomized controlled trial.
   Payen Schalkens E, Acien M, Marchand AA, Isabelle PL, et al · · 2026 · PMID 41544006 · DOI 10.1371/journal.pone.0340905
2. Custom foot orthoses for chronic metatarsalgia: study protocol for a participant- and assessor-blinded superiority randomized controlled trial
   Payen E, Acien M, Marchand A, Isabelle P, et al · · 2025 · DOI 10.21203/rs.3.rs-6621282/v1