Actively Recruiting
Randomized Controlled Trial of Custom Foot Orthoses for Chronic Forefoot Pain
Led by Université du Québec à Trois-Rivières · Updated on 2026-02-10
64
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
U
Université du Québec à Trois-Rivières
Lead Sponsor
F
Fonds de la Recherche en Santé du Québec
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Randomized Controlled Trial of Custom Foot Orthoses for Chronic Forefoot Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Are aged 18 years or over
- Have bilateral or unilateral metatarsalgia under one or more of the lesser metatarsal heads for at least 3 months with a pain score of 4 or higher out of 10
- Pain is worsened by weight-bearing activities
- Able to walk without assistive devices such as a cane or walker
- Willing to wear shoes that accommodate foot orthoses daily
- Willing to minimize use of other treatments like pain medications or physical therapy during the trial period
You will not qualify if you...
- Have arthritis
- Have neurological diseases such as intermetatarsal neuroma or other mechanical foot pain like plantar corns
- Have a history of orthopedic foot surgery
- Have previously used customized foot orthoses
- Have cognitive impairments
- Are pregnant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, Canada, G9A 5H7
Actively Recruiting
Research Team
E
Eléna Payen, Msc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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