Custom medially-wedged foot orthoses with a metatarsal pad versus sham for chronic forefoot (metatarsal) pain

A Participant- and Assessor-blinded Superiority Randomized Controlled Trial of Custom Foot Orthoses for Chronic Metatarsalgia

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Université du Québec à Trois-Rivières (Academic / other)
• Locations: 1 site (Trois-Rivières, Quebec)
• Trial ID: NCT06962475 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Trois-Rivières, Quebec

• Université du Québec à Trois-Rivières — Trois-Rivières, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: Eléna Payen, Msc

Conditions Metatarsalgia; RCT; Foot Orthoses; Sham; Customized