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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)

29 мая 2026 г. обновлено: 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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

108

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Места учебы

  • Франция
      • Besançon, Франция
        • CHU de Besançon
        • Контакт:
          • Fabrice MICHEL
          • Номер телефона: 03 81 66 89 50
          • Электронная почта: fmichel@chu-besancon.fr
      • Bordeaux, Франция
        • CHU de Bordeaux
        • Контакт:
      • Nantes, Франция
        • CHU de Nantes
        • Контакт:
      • Paris, Франция
        • Hôpital Universitaire Paris Cochin
        • Контакт:
          • François RANNOU
          • Номер телефона: 01 58 41 23 35
          • Электронная почта: francois.rannou@aphp.fr
      • Strasbourg, Франция
        • Institut Universitaire de Réadaptation Clémenceau
        • Контакт:
          • Marie-Eve ISNER-HOROBETI
          • Номер телефона: 03.88.21.16.39
          • Электронная почта: marieeve.isner@gmail.com
      • Toulouse, Франция
        • CHU de Toulouse
    • Gard
      • Nîmes, Gard, Франция, 30029
        • Centre Hospitalier Universitaire de Nîmes
        • Контакт:
          • Anissa Megzarri
          • Номер телефона: 04 66 68 68 68
          • Электронная почта: drc@chu-nimes.fr

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Тройной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Инъекция ботулотоксина
Лекарство: 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
Плацебо Компаратор: Инъекция плацебо
Лекарство: 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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in sciatic pain
Временное ограничение: From baseline to Week 6
Measured on a 0 (no pain) to 10 (worst pain) visual analog scale
From baseline to Week 6

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in buttock pain intensity
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Baseline
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Baseline
Sciatic pain intensity
Временное ограничение: Week 3
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 3
Sciatic pain intensity
Временное ограничение: Week 6
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 6
Sciatic pain intensity
Временное ограничение: Week 9
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 9
Sciatic pain intensity
Временное ограничение: Week 12
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 12
Sciatic pain intensity
Временное ограничение: Week 15
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 15
Sciatic pain intensity
Временное ограничение: Week 18
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 18
Sciatic pain intensity
Временное ограничение: Week 21
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 21
Sciatic pain intensity
Временное ограничение: Week 24
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 24
Buttock pain intensity
Временное ограничение: Baseline
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Baseline
Buttock pain intensity
Временное ограничение: Week 3
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 3
Buttock pain intensity
Временное ограничение: Week 6
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 6
Buttock pain intensity
Временное ограничение: Week 9
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 9
Buttock pain intensity
Временное ограничение: Week 12
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 12
Buttock pain intensity
Временное ограничение: Week 15
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 15
Buttock pain intensity
Временное ограничение: Week 18
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 18
Buttock pain intensity
Временное ограничение: Week 21
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 21
Buttock pain intensity
Временное ограничение: Week 24
Assessed on Visual Analog Scale value (0 = no pain, 10 = worst pain)
Week 24
Physical functioning
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Baseline
Patient Global Impression of Improvement (PGI-I)
Baseline
Perceived change in condition in response to therapy
Временное ограничение: Week 6
Patient Global Impression of Improvement (PGI-I)
Week 6
Perceived change in condition in response to therapy
Временное ограничение: Week 12
Patient Global Impression of Improvement (PGI-I)
Week 12
Perceived change in condition in response to therapy
Временное ограничение: Week 18
Patient Global Impression of Improvement (PGI-I)
Week 18
Perceived change in condition in response to therapy
Временное ограничение: Week 24
Patient Global Impression of Improvement (PGI-I)
Week 24
Emotional distress
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Baseline
Time between the beginning of the sitting position and the onset or worsening of the pain
Baseline
Tolerance of the sitting position
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Week 24
Time between the beginning of the sitting position and the onset or worsening of the pain
Week 24
Consumption of painkillers
Временное ограничение: 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
Временное ограничение: Week 12
Number
Week 12
Side effects of injection
Временное ограничение: Week 24
Side effects of the injection or attributable to the study drug
Week 24

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Centre Hospitalier Universitaire de Nīmes

Следователи

  • Главный следователь: Arnaud Dupeyron, CHU Nîmes

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 июля 2026 г.

Первичное завершение (Оцененный)

1 января 2029 г.

Завершение исследования (Оцененный)

1 января 2029 г.

Даты регистрации исследования

Первый отправленный

29 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

29 мая 2026 г.

Первый опубликованный (Действительный)

3 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

3 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

29 мая 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

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

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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