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

Phase 3

Completed

• Conditions: Myofascial Pelviperineal Pain
• Interventions: Drug: botulinum toxin A + ropivacaïne; Drug: Ropivacaïne

• Registration Number: NCT01967524
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-23
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-14
• Last Update Posted: 2016-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
botulinum toxin A + ropivacaïne	botulinum toxin A + ropivacaïne	-
Ropivacaïne	Ropivacaïne	-

Primary Outcome Measures

Name	Time	Method
Evolution of the PGI-I (Patient Global Impression of Improvement)	2 month	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.

Secondary Outcome Measures

Name	Time	Method
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
Evaluation of pain on digital scale (EN)	6 month	Evaluation of pain on digital scale (EN), each month after the injection
To assess the evolution of analgesics consumption (score MQS)	6 month

Trial Locations

Locations (6)

Clinique Axium; 🇫🇷 Aix-en-Provence, France

Besançon University Hospital; 🇫🇷 Besançon, France

Nantes University Hospital; 🇫🇷 Nantes, France

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, France

Rennes University Hospital; 🇫🇷 Rennes, France

La Réunion University Hospital; 🇫🇷 Saint Denis de la Réunion, France