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Shoe inserts might soothe back pain for Flat-Footed patients

NCT ID NCT03996980

Symptom relief Sponsor: University of Seville Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether custom-made foot orthoses (shoe inserts) can reduce chronic low back pain in adults with pronated (flat) feet. 110 participants were randomly assigned to wear either custom orthoses or flat insoles for a period. Researchers measured pain levels and disability using standard questionnaires. The goal was to see if correcting foot posture could relieve back pain.

What this could mean

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

Active substance
custom-made foot orthoses
What this could lead to
If it works, this could offer a simple, non-drug way to ease chronic low back pain in people with flat feet.
What could go wrong
This is a small, completed trial with 110 participants. The orthoses may not help everyone, and benefits might be modest or no better than a flat insole.

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

110 people

The number who actually took part.

Started

Jan 2013

Finished

Jul 2019

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 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Males and females between 18 and 65 years old * Presence of CLBP * Foot Posture Index pronated in one or both feet (henceforth, FPI) ≥ +6 Exclusion Criteria: * Serious illness * Current participation in another research study * Pregnancy * Previous back or foot surgery * Current treatment of foot pathology or back, and leg length discrepancy \> 5 mm

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Conditions

The condition(s) this trial relates to.

Low Back Pain

As listed by the trial registrant

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

Chronic low-back pain Foot pronation

Contacts and locations

Locations

  • Manuel Pabón Carrasco

    Seville, Spain

  • university. Departament of Podiatry

    Seville, 41009, Spain

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