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Heel pain breakthrough? new study pits needle therapy against surgery

NCT ID NCT07654660

Symptom relief Sponsor: Universidad Europea de Valencia 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a 6-week non-surgical treatment (manual therapy plus nerve stimulation) with surgery for people who have had heel pain for over 6 months and haven't gotten better with standard care. 120 adults aged 30-65 will choose their preferred treatment and be followed for 6 weeks to see which approach works better for pain and function. The goal is to give patients and doctors clearer evidence on whether to operate or try a more advanced non-surgical option first.

What this could mean

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

Active substance
Multimodal conservative intervention (manual therapy and ultrasound-guided percutaneous neuromodulation) versus endoscopic plantar fascial release surgery
What this could lead to
If it works, this could show that a non-surgical approach is as good as or better than surgery for stubborn heel pain, helping patients avoid an operation.
What could go wrong
This is a relatively small trial (120 people) and participants choose their treatment, which can bias results. The non-surgical treatment is complex and may not work for everyone.

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 120 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

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

30 to 65 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: * Adults aged 30 to 65 years. * Diagnosis of chronic refractory plantar fasciopathy with symptom duration greater than 6 months. * Failure of at least two previous conservative treatments, each lasting at least 12 weeks. * Foot Function Index (FFI) total score ≥45 points. * Resting pain intensity ≥4/10 on the Visual Analog Scale (VAS). * Plantar fascia thickness ≥4 mm at the calcaneal insertion confirmed by ultrasound. * Ability to provide written informed consent and comply with study procedures. Exclusion Criteria: * Previous foot surgery on the affected side. * Calcaneal stress fracture. * Glycated hemoglobin (HbA1c) \>7.5%. * Inability or unwillingness to comply with study procedures or follow-up assessments.

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Conditions

The condition(s) this trial relates to.

plantar fasciitis

As listed by the trial registrant

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

Chronic refractory plantar fasciopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • European University of Valencia

    Valencia, Valencia, 46010, Spain