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Efficacy of Botulinum Toxin Versus Placebo on Pain and Health Related Quality of Life of Patients With Piriformis Muscle Syndrome (PiriTox)

2026年5月29日 更新者：Centre Hospitalier Universitaire de Nīmes

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

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

108

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 法国
      • Besançon、法国
      • Bordeaux、法国
      • Nantes、法国
      • Paris、法国
        • Hôpital Universitaire Paris Cochin
        • 接触：
      • Strasbourg、法国
        • Institut Universitaire de Réadaptation Clémenceau
        • 接触：
      • Toulouse、法国
        • CHU de Toulouse
    • Gard
      • Nîmes、Gard、法国、30029
        • Centre Hospitalier Universitaire de Nîmes
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：肉毒素注射
药品：Botulinum Toxin - A injections
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
安慰剂比较：安慰剂注射
药品：Placebo
Placebo (normal saline solution and excipients described in Xeomin) will be injected in equally divided doses (1mL) into 2 locations in the affected buttock region

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in sciatic pain
大体时间：From baseline to Week 6
Measured on a 0 (no pain) to 10 (worst pain) visual analog scale
From baseline to Week 6

次要结果测量

结果测量
措施说明
大体时间
Change in buttock pain intensity
大体时间：From baseline to Week 6
Measured on a 0 (no pain) to 10 (worst pain) visual analog scale
From baseline to Week 6
Health-related quality of life
大体时间：Baseline
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)
Baseline
Health-related quality of life
大体时间：Week 6
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)
Week 6
Health-related quality of life
大体时间：Week 12
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)
Week 12
Health-related quality of life
大体时间：Week 18
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)
Week 18
Health-related quality of life
大体时间：Week 24
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)
Week 24
Sciatic pain intensity
大体时间：Baseline
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Baseline
Sciatic pain intensity
大体时间：Week 3
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 3
Sciatic pain intensity
大体时间：Week 6
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 6
Sciatic pain intensity
大体时间：Week 9
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 9
Sciatic pain intensity
大体时间：Week 12
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 12
Sciatic pain intensity
大体时间：Week 15
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 15
Sciatic pain intensity
大体时间：Week 18
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 18
Sciatic pain intensity
大体时间：Week 21
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 21
Sciatic pain intensity
大体时间：Week 24
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 24
Buttock pain intensity
大体时间：Baseline
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Baseline
Buttock pain intensity
大体时间：Week 3
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 3
Buttock pain intensity
大体时间：Week 6
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 6
Buttock pain intensity
大体时间：Week 9
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 9
Buttock pain intensity
大体时间：Week 12
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 12
Buttock pain intensity
大体时间：Week 15
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 15
Buttock pain intensity
大体时间：Week 18
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 18
Buttock pain intensity
大体时间：Week 21
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 21
Buttock pain intensity
大体时间：Week 24
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 24
Physical functioning
大体时间：Baseline
Brief Pain Inventory Short Form; 9-item questionnaire, where Worst Pain Score: 1 - 4 = Mild Pain; Worst Pain Score: 5 - 6 = Moderate Pain; Worst Pain Score: 7 - 10 = Severe Pain
Baseline
Physical functioning
大体时间：Week 6
Brief Pain Inventory Short Form; 9-item questionnaire, where Worst Pain Score: 1 - 4 = Mild Pain; Worst Pain Score: 5 - 6 = Moderate Pain; Worst Pain Score: 7 - 10 = Severe Pain
Week 6
Physical functioning
大体时间：Week 12
Brief Pain Inventory Short Form; 9-item questionnaire, where Worst Pain Score: 1 - 4 = Mild Pain; Worst Pain Score: 5 - 6 = Moderate Pain; Worst Pain Score: 7 - 10 = Severe Pain
Week 12
Physical functioning
大体时间：Week 18
Brief Pain Inventory Short Form; 9-item questionnaire, where Worst Pain Score: 1 - 4 = Mild Pain; Worst Pain Score: 5 - 6 = Moderate Pain; Worst Pain Score: 7 - 10 = Severe Pain
Week 18
Physical functioning
大体时间：Week 24
Brief Pain Inventory Short Form; 9-item questionnaire, where Worst Pain Score: 1 - 4 = Mild Pain; Worst Pain Score: 5 - 6 = Moderate Pain; Worst Pain Score: 7 - 10 = Severe Pain
Week 24
Perceived change in condition in response to therapy
大体时间：Baseline
Patient Global Impression of Improvement (PGI-I)
Baseline
Perceived change in condition in response to therapy
大体时间：Week 6
Patient Global Impression of Improvement (PGI-I)
Week 6
Perceived change in condition in response to therapy
大体时间：Week 12
Patient Global Impression of Improvement (PGI-I)
Week 12
Perceived change in condition in response to therapy
大体时间：Week 18
Patient Global Impression of Improvement (PGI-I)
Week 18
Perceived change in condition in response to therapy
大体时间：Week 24
Patient Global Impression of Improvement (PGI-I)
Week 24
Emotional distress
大体时间：Baseline
Hospital Anxiety and Depression Scale (HADS); 14 items, with responses scored on a scale of 0-3 (3 indicates higher symptom frequencies). Subscales (anxiety and depression) range from 0 to 21 whereby: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21.
Baseline
Emotional distress
大体时间：Week 6
Hospital Anxiety and Depression Scale (HADS); 14 items, with responses scored on a scale of 0-3 (3 indicates higher symptom frequencies). Subscales (anxiety and depression) range from 0 to 21 whereby: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21.
Week 6
Emotional distress
大体时间：Week 12
Hospital Anxiety and Depression Scale (HADS); 14 items, with responses scored on a scale of 0-3 (3 indicates higher symptom frequencies). Subscales (anxiety and depression) range from 0 to 21 whereby: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21.
Week 12
Emotional distress
大体时间：Week 18
Hospital Anxiety and Depression Scale (HADS); 14 items, with responses scored on a scale of 0-3 (3 indicates higher symptom frequencies). Subscales (anxiety and depression) range from 0 to 21 whereby: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21.
Week 18
Emotional distress
大体时间：Week 24
Hospital Anxiety and Depression Scale (HADS); 14 items, with responses scored on a scale of 0-3 (3 indicates higher symptom frequencies). Subscales (anxiety and depression) range from 0 to 21 whereby: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21.
Week 24
Disability for low back pain
大体时间：Baseline
Oswestry Disability Index (ODI): range 0 to 100. Zero is equated with no disability and 100 is the maximum disability possible.
Baseline
Disability for low back pain
大体时间：Week 6
Oswestry Disability Index (ODI): range 0 to 100. Zero is equated with no disability and 100 is the maximum disability possible.
Week 6
Disability for low back pain
大体时间：Week 12
Oswestry Disability Index (ODI): range 0 to 100. Zero is equated with no disability and 100 is the maximum disability possible.
Week 12
Disability for low back pain
大体时间：Week 18
Oswestry Disability Index (ODI): range 0 to 100. Zero is equated with no disability and 100 is the maximum disability possible.
Week 18
Disability for low back pain
大体时间：Week 24
Oswestry Disability Index (ODI): range 0 to 100. Zero is equated with no disability and 100 is the maximum disability possible.
Week 24
Tolerance of the sitting position
大体时间：Baseline
Time between the beginning of the sitting position and the onset or worsening of the pain
Baseline
Tolerance of the sitting position
大体时间：Week 6
Time between the beginning of the sitting position and the onset or worsening of the pain
Week 6
Tolerance of the sitting position
大体时间：Week 12
Time between the beginning of the sitting position and the onset or worsening of the pain
Week 12
Tolerance of the sitting position
大体时间：Week 18
Time between the beginning of the sitting position and the onset or worsening of the pain
Week 18
Tolerance of the sitting position
大体时间：Week 24
Time between the beginning of the sitting position and the onset or worsening of the pain
Week 24
Consumption of painkillers
大体时间：Week 24
Number of level 1 to 3 analgesics, non-steroidal anti-inflammatory drugs and muscle relaxants
Week 24
Number of patients requiring a second injection botulinum toxin in each arm
大体时间：Week 12
Number
Week 12
Side effects of injection
大体时间：Week 24
Side effects of the injection or attributable to the study drug
Week 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Centre Hospitalier Universitaire de Nīmes

调查人员

  • 首席研究员：Arnaud Dupeyron、CHU Nîmes

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2029年1月1日

研究完成 (估计的)

2029年1月1日

研究注册日期

首次提交

2026年5月29日

首先提交符合 QC 标准的

2026年5月29日

首次发布 (实际的)

2026年6月3日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月29日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • PHRCN/2019/AD-1
  • 2024-517948-66-00 (克蒂斯)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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