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A phase IIb, randomized, double-blind, multicenter study evaluating the efficacy of botulinum toxin versus placebo on pain and health related quality of life of patients with piriformis muscle syndrome
EU CTIS ID: 2024-517948-66-00
What this study is testing
To evaluate on an exploratory basis, the efficacy of a single-dose injection of botulinum toxin (Toxin group), versus placebo (placebo group) performed under ultrasound (with electromyographic confirmation) or CT guidance in reducing sciatic pain intensity at 6 weeks in patients with piriformis muscle syndrome (PMS).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients (age >or =18 years) with objective clinical diagnosis of piriformis muscle syndrome.
- 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 (at D0) sciatic pain intensity of at least 4 points on visual analog scale (VAS)
- Adult patients aged over 18 and under 80 years
You likely can't join if
- Bilateral piriformis muscle syndrome.
- 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. NB: Women will receive a pregnancy test prior to inclusion in 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.
See the full eligibility criteria
- Adult patients (age >or =18 years) with objective clinical diagnosis of piriformis muscle syndrome.
- 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 (at D0) sciatic pain intensity of at least 4 points on visual analog scale (VAS)
- Adult patients aged over 18 and under 80 years
- Provision of written informed consent.
- Patients affiliated to social security system (health insurance coverage).
- Bilateral piriformis muscle syndrome.
- 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. NB: Women will receive a pregnancy test prior to inclusion in 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.
- 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 during a period of 15 days around BT injection (15 days before and 15 days after BT injection).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.