Custom shoe inserts may ease plantar heel pain

NCT ID NCT06318910

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This trial investigates whether custom foot orthoses (shoe inserts) with or without special wedges can reduce pain and improve foot function in people with plantar heel pain (plantar fasciitis). Participants are randomly assigned to one of three orthosis types and are monitored during standing and walking. The study measures pain levels, foot function, and muscle activity in the legs.

What this could mean

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

Active substance
customized foot orthosis with or without orthotic wedges (a device)
What this could lead to
If effective, these orthoses could provide a simple, non-invasive way to reduce heel pain and improve walking for people with plantar fasciitis.
What could go wrong
This is a small, early-stage trial with 75 participants, so results may not apply to everyone. The benefit over standard care is uncertain.

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

75 people

The number who actually took part.

Started

Apr 2024

Finished

Dec 2024

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 60 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: * Reaching the specific criteria of PHP including * A complaint of tenderness from the palpation of the medial calcaneal tubercle and the medial aspect of the proximal portion of the plantar fascia, or pain along the plantar fascia at medial longitudinal arch side * The presence of heel pain immediately during the first few steps of walking in the morning or after a prolonged period of inactivity; and gradually decreased throughout the day with ordinary walking, and worsened with prolonged activity * Having the symptom of heel pain for at least 6 weeks, indicates the chronic condition * Having the maximum level of pain intensity during last week using the visual analog scale (VAS) at least 3 out of a full 10 scores Exclusion Criteria: * Having positive sciatica test, indicating the L5-S1 nerve root irritation * Having a history of lower extremity fracture * Having a history of lower extremity surgery * Having been diagnosed with gout, diabetic neuropathy, rheumatoid arthritis, systemic lupus erythematosus (SLE), cancer, infectious disease, and tumor

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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.

Contacts and locations

Locations

  • Faculty of Physical Therapy, Mahidol University

    Bangkok, Changwat Nakhon Pathom, 73170, Thailand

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