Randomized Controlled Trial of Custom Foot Orthoses for Chronic Forefoot Pain
RecruitingNot applicableNCT06962475
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Brief summary (from the registry)
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.
Study details
- Official title
- A Participant- and Assessor-blinded Superiority Randomized Controlled Trial of Custom Foot Orthoses for Chronic Metatarsalgia
- Conditions
- Metatarsalgia
- Interventions
- Other: Podiatric advice
- Other: Customized foot orthoses
- Other: Sham foot orthoses
- Sponsor
- Université du Québec à Trois-Rivières
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Start date
- 2025-02-01
- Primary completion
- 2027-08-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Canadian sites (1)
| Facility | City | Province |
|---|---|---|
| Université du Québec à Trois-Rivières | Trois-Rivières | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06962475