Multicenter Randomized Double-blind Study Evaluating the Effects of Botulinum Toxin A Associated With ropivacaïne Versus ropivacaïne Alone in the Treatment of the Myofascial Pelviperineal Pain (MYOTOX)

Myofascial pains are frequently found during the clinical examination of the patients presenting a painful chronic syndrome of the pelvis or the perineum. If the physiopathology of this component of the pain characterized by triggerpoints found in the clinical examination, remains uncertain; its coverage contributes to the improvement of the global pain of the patient. The physiotherapy can be useful but when it is not useful, we proposed injections of triggerpoints by local anesthetics. The injections of botulinum toxin on these triggerpoints have a legitimacy (action on the muscular cramp and action on the afferent fibers) but are they superior to the injections of local anesthetics of triggerpoints? The literature remains poor on the subject, justifying this randomized double-blind protocol comparing the efficacy of the botulinum toxin associated with a local anesthetic versus local anesthetic alone with a main criterion of evaluation in 2 months and a monthly follow-up as long as the patient remains improved and maximum in 6 months.

Study Overview

• Status: Completed
• Conditions: Myofascial Pelviperineal Pain
• Intervention / Treatment: Drug: botulinum toxin A + ropivacaïne; Drug: Ropivacaïne

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Aix-en-Provence, France, 13097
    • Clinique Axium
  • Besançon, France, 25030
    • Besançon University Hospital
  • Clermont-Ferrand, France, 63003
    • Clermont-Ferrand University Hospital
  • Nantes, France, 44093
    • Nantes University Hospital
  • Rennes, France, 35033
    • Rennes University Hospital
  • Saint Denis de la Réunion, France, 97405
    • La Réunion University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 18 years
• Patient presenting a "dysfunctional" pain of the pelvis or the perineum (without lesional pathology justifying a specific treatment) by an endopelvic touch
• Pain evolving since at least 6 months and persisting in spite of the analgesic treatments and the physiotherapy
• Patient presenting to the clinical examination one or several active triggerpoints found on the internal obturating muscles and/or elevators of the anus, with a maximum of 10 triggerpoints on the whole body.
• Patient presenting an average of the maximal pains of the week before the inclusion superior or equal to 4 and inferior or equal to 9/10 (evaluation of the daily maximal pain on a digital scale from 0 to 10)
• Signed informed consent
• Subjects affiliated with an appropriate social security system

Exclusion Criteria:

• Patients with bleeding risk and anticoagulant therapy
• Intolerance of botulinum toxin A, ropivacaïne and nitrous oxide
• Injection of botulinum toxin in any place whatsoever in the previous 3 months
• Pregnancy and breast feeding
• Antibiotic treatment by aminoglycosides
• Recent anti-inflammatory treatment
• Severe myasthenia
• Lambert-Eaton syndrome
• Patients with neurological disorders, dysphagia, food choking or inhalation pneumonia
• Beck score > 16
• Patients having an average of the maximal pains of the previous week lower than 4

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: botulinum toxin A + ropivacaïne	Drug: botulinum toxin A + ropivacaïne; D0 : Calcul of the average of EN (digital scale) (EN completed from D-8 to D-1); QDSA (Saint-Antoine pain questionnaire); QCD (Pain questionnaire); MPI (Multidimensional Pain Inventory); Beck scale; HAD (Hospital Anxiety and Depression scale); SF36 (Short Form 36); injection of botulinum toxin A associated with ropivacaïne D30, D90, D120 and D150 (phone call): Calcul of the average of EN D60 and D180 (on site visits): adverse events reporting, calcul of the average of EN, PGI-I (Patient Global Impression of Improvement), questionnaires (QDSA, QCD, MPI, treatment satisfaction, Beck scale, HAD and SF36).
Active Comparator: Ropivacaïne	Drug: Ropivacaïne; D0 : Calcul of the average of EN (digital scale) (EN completed from D-8 to D-1); QDSA (Saint-Antoine pain questionnaire); QCD (Pain Questionnaire); MPI (Multidimensional Pain Inventory); Beck scale; HAD (Hospital Anxiety and Depression scale); SF36 (Short Form 36); injection of ropivacaïne alone D30, D90, D120 and D150 (phone call): Calcul of the average of EN D60 and D180 (on site visits): adverse events reporting, calcul of the average of EN, PGI-I (Patient Global Impression of Improvement), questionnaires (QDSA, QCD, MPI, treatment satisfaction, Beck scale, HAD and SF36).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the PGI-I (Patient Global Impression of Improvement)	The main objective is to evaluate the efficacy of injection of botulinum toxin A associated with ropivacaïne versus ropivacaïne alone on the global suffering of chronic myofascial pelviperineal syndromes two month after the injection. The success will be defined as an improvement of the PGI-I corresponding to the first 2 levels.	2 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of pain on digital scale (EN)	Evaluation of pain on digital scale (EN), each month after the injection	6 month
To assess the changing parameters of quality of life: global improvement score / treatment satisfaction assessed by digital scale, international pain scales (MPI, QDSA, QCD) / Beck and HAD score		6 month
To assess the evolution of analgesics consumption (score MQS)		6 month

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Jean-Jacques LABAT, Dr, Nantes University Hospital

Publications and helpful links

General Publications

• Levesque A, Ploteau S, Michel F, Siproudhis L, Bautrant E, Eggermont J, Rabischong B, Volteau C, Perrouin-Verbe MA, Labat JJ. Botulinum toxin infiltrations versus local anaesthetic infiltrations in pelvic floor myofascial pain: Multicentre, randomized, double-blind study. Ann Phys Rehabil Med. 2021 Jan;64(1):101354. doi: 10.1016/j.rehab.2019.12.009. Epub 2020 Jan 22.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: October 18, 2013
• First Submitted That Met QC Criteria: October 18, 2013
• First Posted (Estimate): October 23, 2013

Study Record Updates

• Last Update Posted (Estimate): December 15, 2016
• Last Update Submitted That Met QC Criteria: December 14, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Myofascial pain; Botulinum toxin type A; Chronic pelvic pain; Perineal pain; Ropivacaïne
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Cholinergic Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Ropivacaine
• Other Study ID Numbers: RC13_0061