Clinical trial NCT01967524: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myofascial Pelviperineal Pain
Keywords: Myofascial pain
Perineal pain
Chronic pelvic pain
Botulinum toxin type A
Ropivacaïne
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-10-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evolution of the PGI-I (Patient Global Impression of Improvement)
timeFrame: 2 month
Secondary outcomes:
measure: Evaluation of pain on digital scale (EN)
timeFrame: 6 month
measure: 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
timeFrame: 6 month
measure: To assess the evolution of analgesics consumption (score MQS)
timeFrame: 6 month
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Clinique Axium
city: Besançon
country: France
facility: Besançon University Hospital
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Saint Denis de la Réunion
country: France
facility: La Réunion University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Jean-Jacques LABAT, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.