Recruiting

Medially Wedged FOs

Sponsor:

Université du Québec à Trois-Rivières

Code:

NCT06962475

Conditions

Metatarsalgia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Podiatric advice

Customized foot orthoses

Sham foot orthoses

Study Details

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

Study ID

NCT06962475

Start date

Feb 1, 2025

Status verified date

Feb, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Intervention Group

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

sham comparator: Control group

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

Interventions

Podiatric advice

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.

Customized foot orthoses

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.

Sham foot orthoses

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.

Primary outcome measure

  • Mean pain during walking for the most painful foot during the past week [ Time Frame: From Baseline to the end of follow-up at 12 weeks ]

Central Contacts and Locations

Central contacts

Eléna Payen, Msc

873 887 9707elena.payen@uqtr.ca

Locations

Université du Québec à Trois-Rivières

Recruiting

Trois-Rivières, Quebec, Canada, G9A 5H7

Contacts

Eléna Payen Schalkens

873 887 9707elena.payen.schalkens@uqtr.ca

More Information

Sponsor

Université du Québec à Trois-Rivières

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • RCT
  • Metatarsalgia
  • Foot Orthoses
  • Sham
  • Customized

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université du Québec à Trois-Rivières on 2026-02-10.