Custom shoe inserts could ease chronic foot pain
NCT ID NCT06962475
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether custom foot orthoses (special shoe inserts with a wedge and pad) can reduce pain and improve foot function in people with chronic metatarsalgia, a condition causing persistent pain under the ball of the foot. Sixty-four adults with at least 3 months of foot pain will receive either custom orthoses or sham (fake) orthoses and be followed for 12 weeks. The goal is to see if the custom design offers real relief compared to a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- custom foot orthoses (medially wedged with metatarsal pad)
- What this could lead to
- If it works, this could provide an effective, non-invasive option for reducing foot pain and improving daily function in people with chronic metatarsalgia.
- What could go wrong
- This is a small, early-stage trial with only 64 participants, so results may not apply to everyone. The sham orthoses may also provide some benefit, making it harder to prove a clear advantage.
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 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2025
- Expected to finish
-
Aug 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 years and older
- 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 Hide 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. 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metatarsalgia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Université du Québec à Trois-Rivières
RECRUITINGTrois-Rivières, Quebec, G9A 5H7, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.