Custom shoe inserts may ease plantar heel pain
NCT ID NCT06318910
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
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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
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75 people
The number who actually took part.
- Started
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Apr 2024
- Finished
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Dec 2024
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Faculty of Physical Therapy, Mahidol University
Bangkok, Changwat Nakhon Pathom, 73170, Thailand
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