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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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

108

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • フランス
      • Besançon、フランス
        • CHU de Besançon
        • コンタクト：
      • Bordeaux、フランス
      • Nantes、フランス
      • Paris、フランス
        • Hôpital Universitaire Paris Cochin
        • コンタクト：
      • Strasbourg、フランス
        • Institut Universitaire de Réadaptation Clémenceau
        • コンタクト：
      • Toulouse、フランス
        • CHU de Toulouse
    • Gard
      • Nîmes、Gard、フランス、30029
        • Centre Hospitalier Universitaire de Nîmes
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：ボツリヌストキシン注射
薬：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
プラセボコンパレーター：プラセボ注射
薬：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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in sciatic pain
時間枠：From baseline to Week 6
Measured on a 0 (no pain) to 10 (worst pain) visual analog scale
From baseline to Week 6

二次結果の測定

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Centre Hospitalier Universitaire de Nīmes

捜査官

  • 主任研究者：Arnaud Dupeyron、CHU Nîmes

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2029年1月1日

研究の完了 (推定)

2029年1月1日

試験登録日

最初に提出

2026年5月29日

QC基準を満たした最初の提出物

2026年5月29日

最初の投稿 (実際)

2026年6月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月3日

QC基準を満たした最後の更新が送信されました

2026年5月29日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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