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Can custom foot inserts ease bunion pain? a trial puts them to the test

NCT ID NCT07781735

Symptom relief Sponsor: Université du Québec à Trois-Rivières Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This pilot trial investigates whether custom-made, prefabricated, or sham foot orthoses can reduce pain and improve function in people with painful hallux valgus (bunions). Thirty-six adults with painful bunions will be randomly assigned to one of three orthosis groups, and all will receive a standardized exercise and education program. The study primarily assesses feasibility—such as recruitment and adherence—while also measuring pain, function, and quality of life over 12 weeks. The results will help design a larger, definitive trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Foot orthoses (custom-made, prefabricated, and sham 3D-printed devices) plus a standardized program of foot exercises and education
What this could lead to
If this pilot succeeds, it could pave the way for a larger trial that may identify which type of foot orthosis best reduces pain and improves function in people with hallux valgus.
What could go wrong
This is a small pilot study focused on feasibility, not proof of effectiveness. Results may not generalize, and the sham orthoses may not fully blind participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged 18 to 74 years; 2. Have unilateral or bilateral hallux valgus (Manchester scale ≥ 2) with pain for at least 3 months (average pain score ≥ 3 out of 10 on a Visual Analogue Scale (VAS)) that is aggravated by weight-bearing activities. If participants have bilateral hallux valgus, the most painful foot will be used for data collection. Participants with pain secondary to friction between the first metatarsophalangeal joint and the shoe will be excluded unless the intra-articular or plantar pain is more significant; 3. Can walk without assistive devices (e.g., cane, walker); 4. Are willing to wear shoes that accommodate their foot orthoses daily; 5. Are willing to minimize the use of other interventions (e.g., pain medications, physical therapy) during the trial period. Exclusion Criteria: 1. Inflammatory conditions (e.g., arthritis, gout), neurological diseases and other sources of mechanical foot pain; 2. History of orthopedic foot surgery; 3. Prior use of custom or prefabricated foot orthoses in the past 12 weeks; 4. Cognitive impairment; 5. Currently pregnant or breastfeeding; 6. Participation in foot exercises within the past 12 weeks; 7. Less than 10 degrees range of motion at the first metatarsophalangeal joint.

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Conditions

The condition(s) this trial relates to.

Hallux Valgus Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hallux valgus

How to take part

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  1. The places running it

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  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Université du Québec à Trois-Rivières

    Trois-Rivières, Quebec, G9A5H7, Canada

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