Status:
NOT_YET_RECRUITING
Randomized Controlled Trial of Custom Foot Orthoses for Chronic Forefoot Pain
Lead Sponsor:
Université du Québec à Trois-Rivières
Collaborating Sponsors:
Fonds de la Recherche en Santé du Québec
Conditions:
Metatarsalgia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 pre...
Detailed Description
Foot musculoskeletal disorders cause significant impairments and disabilities for those affected. Among the various types of foot pain, chronic metatarsalgia (CM) is the most prevalent. Metatarsalgia ...
Eligibility Criteria
Inclusion
- 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 (pain score of ≥ 4 out of 10 on a Visual Analogue Scale (VAS)) that is aggravated by weight-bearing activities,
- are able to walk without assistive devices (e.g., cane, walker),
- are willing to wear shoes that will accommodate their FOs on a daily basis and
- are willing to minimize the use of other interventions (e.g., pain medications, physical therapy) during the trial period
Exclusion
- have arthritis,
- have neurological diseases (e.g., intermetatarsal neuroma) or other mechanical pain, plantar corns (e.g., intractable plantar keratoma),
- have a history of orthopedic foot surgery,
- have prior use of customized FOs,
- have cognitive impairments,
- are pregnant.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06962475
Start Date
August 1 2025
End Date
October 1 2026
Last Update
May 14 2025
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