Botox injection may ease stubborn buttock and leg pain
NCT ID NCT07624045
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Piriformis muscle syndrome are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
7 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.