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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 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

108

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Francja
      • Besançon, Francja
      • Bordeaux, Francja
      • Nantes, Francja
      • Paris, Francja
        • Hôpital Universitaire Paris Cochin
        • Kontakt:
      • Strasbourg, Francja
        • Institut Universitaire de Réadaptation Clémenceau
        • Kontakt:
      • Toulouse, Francja
        • CHU de TOULOUSE
    • Gard
      • Nîmes, Gard, Francja, 30029
        • Centre Hospitalier Universitaire de Nīmes
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Iniekcja toksyny botulinowej
Lek: 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
Komparator placebo: Wstrzyknięcie placebo
Lek: 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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in sciatic pain
Ramy czasowe: From baseline to Week 6
Measured on a 0 (no pain) to 10 (worst pain) visual analog scale
From baseline to Week 6

Miary wyników drugorzędnych

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Śledczy

  • Główny śledczy: Arnaud Dupeyron, CHU Nimes

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 stycznia 2029

Ukończenie studiów (Szacowany)

1 stycznia 2029

Daty rejestracji na studia

Pierwszy przesłany

29 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 maja 2026

Pierwszy wysłany (Rzeczywisty)

3 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Zespół mięśni gruszkowatych

Badania kliniczne na Botulinum Toxin - A injections

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