Randomized Controlled Trial of Custom Foot Orthoses for Chronic Forefoot Pain

NCT06962475 | Recruiting DMC

• 1 other identifier: 2025_UQTR_FOs_RCT
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metatarsalgia

Keywords

RCT; Metatarsalgia; Foot Orthoses; Sham; Customized

Outcome Measures

Primary Outcomes (1)

• Mean pain during walking for the most painful foot during the past week

  visual analog scale (from 0 to 10, 0 being no pain and 10 pain as bad as it could be).

  From Baseline to the end of follow-up at 12 weeks

Secondary Outcomes (3)

• Foot Function Index (FFI)

  From Baseline to the end of follow-up at 12 weeks

• Global rating of change (GROC)

  During the follow-up: 6weeks and 12 weeks

• Health-related quality of life (HRQoL)

  From Baseline to the end of follow-up at 12 weeks

Other Outcomes (2)

• Demographic and clinical data

  Baseline

• Effects of the FOs on plantar pressure

  Baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants randomized to the intervention group will receive customized FOs for both feet.

Other: Podiatric advice; Other: Customized foot orthoses

Control group

SHAM COMPARATOR

Participants randomized to the control group will receive sham FOs for both feet.

Other: Podiatric advice; Other: Sham foot orthoses

Interventions

Podiatric advice OTHER

A podiatrist with 11 years of clinical experience will take the negative foot impressions using a semi-weightbearing method with a foam box for both groups to ensure adequate blinding of participants. Then, the foam boxes of the experimental group will be scanned so that the FOs can be 3D printed. Both groups will receive identical clinical guideline-based information and support at the beginning of the trial. The instructions will be as follows: (1) undertake a familiarization protocol of 14 consecutive full days (2) wear the FOs (customized or sham) at all time when they are standing (targeted minimum of 5 hours per day), (3) avoid positions that cause the metatarsophalangeal joints to dorsiflex (e.g., squatting or tiptoeing), (4) mechanical stress load management according to the tissue stress model, (5) do not walk barefoot and (6) wear shoes with good cushioning in which the FOs will be properly placed.

Control group; Intervention Group

Customized foot orthoses OTHER

The customized foot orthoses will be manufactured with a Nylon-11 shell with 6° medially wedged forefoot-rearfoot posts (2.6 mm if the participants' weight (PW) is inferior or equal to 45 kg; 3.2 mm if 45\<PW\<100 kg; 4.0 mm if PW\>100 kg), a full-length 3 mm Poron top cover and a metatarsal pad (15 shore A) located 5 mm proximal to the metatarsal heads.

Intervention Group

Sham foot orthoses OTHER

The molded sham FOs will be manufactured from 3 mm ethylene vinyl acetate. They will have an identical top cover material, color and a similar shape than the customized FOs, however, they will provide negligible mechanical support, considering the very low stiffness of their medial arch. The only impact of these FOs on plantar pressure is under the heel. These devices have been used as a sham condition in previous trials and a study has validated them as being credible.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université du Québec à Trois-Rivières: lead
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G9A 5H7, Canada

RECRUITING

Related Publications (1)

• Payen Schalkens E, Acien M, Marchand AA, Isabelle PL, Abboud J, Moisan G. Custom foot orthoses for chronic metatarsalgia: Study protocol for a participant- and assessor-blinded superiority randomized controlled trial. PLoS One. 2026 Jan 16;21(1):e0340905. doi: 10.1371/journal.pone.0340905. eCollection 2026.

  PMID: 41544006 DERIVED

MeSH Terms

Conditions

Metatarsalgia

Condition Hierarchy (Ancestors)

Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eléna Payen, Msc

CONTACT

873 887 9707; elena.payen@uqtr.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: May 8, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

CA (1)