CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS for Piriformis muscle syndrome|Piriformis syndrome

Inclusion criteria

• {"criterion_text":"- Adult patients (age >or =18 years) with objective clinical diagnosis of piriformis muscle syndrome.\n- 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\n- Absence of herniated lumbar disc which can explain radiating pain (MRI or computed tomography (CT) of the lumbar spine)\n- Patients not responding to conventional care (physiotherapy, muscle relaxants, analgesics)\n- Baseline (at D0) sciatic pain intensity of at least 4 points on visual analog scale (VAS)\n- Adult patients aged over 18 and under 80 years\n- Provision of written informed consent.\n- Patients affiliated to social security system (health insurance coverage)."}

Exclusion criteria

• {"criterion_text":"- Bilateral piriformis muscle syndrome.\n- 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.\n- Patients unable to complete the patient diary.\n- Inability to understand the reasons for the study; psychiatric disorders judged by the investigator to be incompatible with inclusion in the study.\n- Patients with legal disability or limited legal capacity.\n- Patients judged as noncompliant.\n- History of piriformis syndrome surgery.\n- History of botulinum toxin administration.\n- Any treatment (general or local) likely to interfere with botulinum toxin or evaluation of the primary endpoint (Corticosteroids, aminoglycosides).\n- Corticosteroids in the past 3 weeks.\n- Signs of severe fibrosis (on MRI or CT) of the piriformis muscle.\n- Other causes of sciatic pain (lumbar root compression, inflammatory, infectious or neoplasic pelvic disease, particularly for inflammatory sacroiliac pain).\n- Hip prosthesis on the same side as piriformis syndrome; knee prosthesis is tolerated.\n- 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)."}

Primary endpoints

• {"endpoint_text":"- The change in sciatic pain intensity, from baseline, at 6 weeks after injection. The sciatic pain will be measured by VAS (100mm scale). The patient will answer the following question: “What was the average intensity of your pain over the last 24 hours?”.","definition_or_measurement_approach":"Sciatic pain measured by VAS (100 mm scale); patient answers: “What was the average intensity of your pain over the last 24 hours?”. Change from baseline at 6 weeks after injection."}

Secondary endpoints

• {"endpoint_text":"- Change in buttock pain intensity (assessed on Visual Analog Scale value, 0 = no pain, 10 = worst pain), from baseline, at 6 weeks after injection.","definition_or_measurement_approach":"Buttock pain intensity assessed on Visual Analog Scale (0–10), change from baseline at 6 weeks."}
• {"endpoint_text":"- Variations from baseline in Health-related quality of life (HRQoL) (EQ-5D) at 6 weeks after injection as well as over a period of 6 months. HRQoL will be assessed at each visit (at inclusion and at 6, 12, 18 and 24 weeks of follow-up after injection).","definition_or_measurement_approach":"HRQoL assessed using the EQ-5D questionnaire at inclusion and weeks 6, 12, 18, and 24; changes from baseline at 6 weeks and over 6 months."}
• {"endpoint_text":"- Variations from baseline, over the 6-month follow-up, in sciatic pain intensity (VAS value), in buttock pain intensity (on VAS), in quality of life (HRQoL, EQ-5D) at 6 weeks after injection as well as over a period of 6 months, in physical functioning (BPI and PGI-I), in anxiety and depression (HADS) over 6 months in disability (ODI), in the tolerance of the sitting position assessed at each visit, consumption of painkillers.","definition_or_measurement_approach":"Multiple measures: VAS for sciatic and buttock pain, EQ-5D for HRQoL, Brief Pain Inventory (BPI) and Patient Global Impression of Improvement (PGI-I) for physical functioning, Hospital Anxiety and Depression Scale (HADS) for anxiety/depression, Oswestry Disability Index (ODI) for disability, sitting tolerance assessed at each visit, and consumption of analgesics; assessed over 6 months versus baseline."}
• {"endpoint_text":"- Number of patients requiring a second injection (botulinum toxin) at 12 weeks in each arm.","definition_or_measurement_approach":"Count of patients in each arm requiring a second botulinum toxin injection at 12 weeks."}
• {"endpoint_text":"- Side effects of treatment during follow-up in each arm.","definition_or_measurement_approach":"Safety and adverse events recorded during follow-up in each arm."}

France

Earliest CTIS Part Ii Submission Date

25-06-2025

Latest Decision Or Authorization Date

21-10-2025

Processing Time Days

118

Number Of Sites

9

Number Of Participants

108

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nimes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France