Efficacy of Botulinum Toxin Versus Placebo on Pain and He... | NCT07624045

ID	Type	Description	Link
2024-517948-66-00	EU Trial (CTIS) Number

Status Module

Description Module

Brief Summary

Piriformis muscle syndrome (PMS) is characterized by symptoms caused by compression or irritation of the sciatic nerve by the piriformis muscle as it exits the sciatic notch. PMS commonly evokes the symptoms of sciatica and is likely underdisagnosed. Patients who experience pain related to piriformis syndrome will complain of aggravated pain after prolonged periods of sitting or upon rising from a seated position. Around 98% of patients evoke positional buttock pain, especially during prolonged sitting (car journeys, for example). This is less true for sciatic pain radiation, which is still found in 63% of cases, systematically associated with the notion of buttock pain. Treatments for PMS aim to reduce or eliminate sciatic pain and also control buttock pain. Reducing these pains can improve the physical condition and emotional state of the patient. Several approaches have been proposed including physical therapy (massage-physiotherapy, self-rehabilitation techniques) combined with the use of anti-inflammatory drugs, analgesics and muscle relaxants to reduce inflammation, spasm and pain. Many patients do not respond to conventional care. Surgery may be considered only in those cases who do not improve with conservative therapy or injections. However, decompressive surgery is an invasive treatment, indicated in case of complete failure of all medical strategies, with physical and functional consequences. In recent years, several published studies showed the use of botulinum toxin (BT) injection as a new therapeutic option to reduce buttock and sciatic pain induced by PMS. The study team previously observed the efficacy of BT/A1 administration into the piriformis muscle in patients who were previously treated with medication and rehabilitation protocols with no pain improvement. Pain relief was considered as "very good" or "good" for 77% of the patients, "average" for 7.4% and "poor" for 15.6%. No adverse events were reported. More recently, Fishman and colleagues reported the results of a randomized, double-blind, controlled study including 56 patients and comparing physical therapy, incobotulinum toxin A and placebo. Data are sparse concerning BT injection for PMS and no multicenter randomized clinical trial have been performed. Two out of three randomized trials (Fishman 2004, 2017) are based on highly selected patients (3 standard deviations or more beyond on the prolongation of the posterior tibial or fibular nerve H-reflex in FAIR test). Therefore, BT efficacy may be overestimated and remains to be evaluated among unselected PMS patients, regardless of analgesic treatments or physical therapy. Finally, no randomized studies have reported the heatlh-related quality of life of PMS patients.

Label	Type	Description	Intervention Names
Botulinum toxin injection	Experimental		Drug: Botulinum Toxin - A injections
Placebo injection	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Botulinum Toxin - A injections	Drug	Incobotulinumtoxin type A (200 U in 2 mL of preservative-free normal saline) will be injected in equally divided doses (1mL; 100 U for incobotulinumtoxin A) into 2 locations in the affected buttock region

Outcomes Module

Measure	Description	Time Frame
Change in sciatic pain	Measured on a 0 (no pain) to 10 (worst pain) visual analog scale	From baseline to Week 6

Secondary Outcomes

Measure	Description	Time Frame
Change in buttock pain intensity	Measured on a 0 (no pain) to 10 (worst pain) visual analog scale	From baseline to Week 6
Health-related quality of life	EuroQol-5 Dimension questionnaire measuring five items representing the five dimensions, and a visual analog scale graduated from 0 to 100 (100 referring to the "best possible state of health"). For each dimension, patients indicate their current state of health to generated a 5-digit number describing the health status (e.g., health status "11111" indicates the absence of problems in each dimension)

Eligibility Module

Eligibility Criteria

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.

ID	Term
D020426	Sciatic Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D009408	Nerve Compression Syndromes
D009437	Neuralgia
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D017699	Pelvic Pain