Custom medially-wedged foot orthoses with a metatarsal pad versus sham for chronic forefoot (metatarsal) pain
Official title: A Participant- and Assessor-blinded Superiority Randomized Controlled Trial of Custom Foot Orthoses for Chronic Metatarsalgia
Run by Université du Québec à Trois-Rivières · NCT06962475 · Data updated 2026-11-12
This will test whether custom medially-wedged foot orthoses with a metatarsal pad relieve pain and improve foot function in adults with chronic metatarsalgia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 64 (estimated) |
| Sponsor | Université du Québec à Trois-Rivières Academic / other |
| Locations | 1 site (Trois-Rivières, Quebec) |
| Status | Recruiting |
| Started | February 1, 2025 |
| Main results expected | August 1, 2027 |
| Study ends | August 1, 2027 |
| Registry record updated | February 10, 2026 |
| Trial ID | NCT06962475 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with unilateral or bilateral metatarsalgia for at least three months, pain ≥4/10 aggravated by weight-bearing, able to walk without assistive devices, and willing to wear footwear that fits the orthoses are ideal candidates.
✕Probably not a fit
Patients whose forefoot pain is due to arthritis, neurological conditions (e.g., intermetatarsal neuroma), prior foot surgery, prior use of custom orthoses, pregnancy, or cognitive impairment are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a participant- and assessor-blinded randomized controlled trial in Trois-Rivières, Canada, comparing customized foot orthoses incorporating a medial wedge and metatarsal pad with sham orthoses. Sixty-four adults with at least three months of metatarsalgia will be recruited from a university outpatient podiatry clinic and via social media and randomized to one of two parallel groups. Outcomes focus on forefoot pain and foot function, with biomechanical rationale that the orthoses reduce plantar pressure under the metatarsal heads. Participants and assessors are blinded to allocation and will receive standard podiatric advice in addition to their allocated device.
Why it matters
Potential benefit: If effective, the orthoses could reduce forefoot pain and improve walking and daily function, potentially lowering reliance on more invasive treatments.
How similar studies have gone: Biomechanical studies and smaller clinical reports show that orthoses can reduce forefoot plantar pressure and symptoms, but high-level randomized evidence specifically for chronic metatarsalgia remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. are aged 18 years or over, 2. have bilateral or unilateral metatarsalgia under one or more of the lesser metatarsal heads for at least 3 months (pain score of ≥ 4 out of 10 on a Visual Analogue Scale (VAS)) that is aggravated by weight-bearing activities, 3. are able to walk without assistive devices (e.g., cane, walker), 4. are willing to wear shoes that will accommodate their FOs on a daily basis and 5. are willing to minimize the use of other interventions (e.g., pain medications, physical therapy) during the trial period Exclusion Criteria: 1. have arthritis, 2. have neurological diseases (e.g., intermetatarsal neuroma) or other mechanical pain, plantar corns (e.g., intractable plantar keratoma), 3. have a history of orthopedic foot surgery, 4. have prior use of customized FOs, 5. have cognitive impairments, 6. are pregnant.
Where it's running
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Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, Canada Recruiting
Study contacts
- Study coordinator: Eléna Payen, Msc
- Email: elena.payen@uqtr.ca
- Phone: 873 887 9707
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.