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Randomized Controlled Trial of Custom Foot Orthoses for Chronic Forefoot Pain

RecruitingNAAges 18 Years - anyAllUniversité du Québec à Trois-Rivières
NCT06962475 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Podiatric advice
  • Customized foot orthoses
  • Sham foot orthoses
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Where

1 site
Université du Québec à Trois-Rivières
Trois-Rivières, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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