Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

29. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

108

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Botulinum toksin injektion
Medicin: 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
Placebo komparator: Placebo injektion
Medicin: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in sciatic pain
Tidsramme: From baseline to Week 6
Measured on a 0 (no pain) to 10 (worst pain) visual analog scale
From baseline to Week 6

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Efterforskere

  • Ledende efterforsker: Arnaud Dupeyron, CHU Nîmes

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. januar 2029

Studieafslutning (Anslået)

1. januar 2029

Datoer for studieregistrering

Først indsendt

29. maj 2026

Først indsendt, der opfyldte QC-kriterier

29. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Piriformis muskelsyndrom

Kliniske forsøg med Botulinum Toxin - A injections

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Uzbekistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner