Custom foot orthoses for chronic metatarsalgia: Study protocol for a participant- and assessor-blinded superiority randomized controlled trial.

ABSTRACT:

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 recruite

SUBMITTER: Payen Schalkens E 

PROVIDER: S-EPMC12810774 | biostudies-literature | 2026

REPOSITORIES: biostudies-literature