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Botox injection may ease stubborn buttock and leg pain

NCT ID NCT07624045

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether injecting botulinum toxin (like Botox) into the piriformis muscle can reduce pain and improve quality of life in people with piriformis muscle syndrome. About 108 adults who have had buttock or leg pain for at least 3 months and haven't gotten relief from physical therapy or painkillers will receive either the toxin or a placebo. The goal is to see if this treatment offers a less invasive option before considering surgery.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 108 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

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 to 80 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: * Objective clinical diagnosis of unilateral piriformis syndrome for at least 3 months (as assessed by Clinical Scoring System for the Diagnosis of Piriformis Muscle Syndrome: score of 8 or greater * Absence of herniated lumbar disc which can explain radiating pain (MRI or computed tomography (CT) of the lumbar spine) * Patients not responding to conventional care (physiotherapy, muscle relaxants, analgesics) * Baseline sciatic pain intensity of at least 4 points on visual analog scale * Provision of written informed consent * Patients affiliated to social security system (health insurance coverage). Exclusion Criteria: * Bilateral piriformis muscle syndrome. * History of piriformis syndrome surgery. * History of botulinum toxin administration. * Any treatment (general or local) likely to interfere with botulinum toxin or evaluation of the primary endpoint (Corticosteroids, aminoglycosides). * Corticosteroids in the past 3 weeks. * Signs of severe fibrosis (on MRI or CT) of the piriformis muscle. * Other causes of sciatic pain (lumbar root compression, inflammatory, infectious or neoplasic pelvic disease, particularly for inflammatory sacroiliac pain). * Hip prosthesis on the same side as piriformis syndrome; knee prosthesis is tolerated. * Contraindication to BT injection: * History of intolerance, hypersensitivity or known allergy to any botulinum toxin product or excipients; * Patients with myasthenia gravis or other diseases of the neuromuscular junction; * Patients with Lambert-Eaton Syndrome; * Patients with neurological disorders such as dysphagia, swallowing disorders or aspiration pneumonia; * Current infection at the proposed injection site; * Long-term anticoagulant therapy ; * Antibiotics and vaccination are prohibited for 15 days before and after BT injection * Pregnant or breastfeeding women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant must use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, method of double-barrier contraceptive patches). The contraception should be maintained throughout the study. * Patients unable to complete the patient diary. * Inability to understand the reasons for the study; psychiatric disorders judged by the investigator to be incompatible with inclusion in the study. * Patients with legal disability or limited legal capacity. * Patients judged as noncompliant.

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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.

How to take part

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

  1. The places running it

    7 sites. 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

  • CHU de Besançon

    Besançon, France

  • CHU de Bordeaux

    Bordeaux, France

  • CHU de Nantes

    Nantes, France

  • CHU de Toulouse

    Toulouse, France

  • Centre Hospitalier Universitaire de Nîmes

    Nîmes, Gard, 30029, France

  • Hôpital Universitaire Paris Cochin

    Paris, France

  • Institut Universitaire de Réadaptation Clémenceau

    Strasbourg, France

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