Overview

This trial is active, not recruiting.

Condition myofascial pelviperineal pain
Treatments botulinum toxin a + ropivacaïne, ropivacaïne
Phase phase 3
Sponsor Nantes University Hospital
Start date September 2013
End date August 2016
Trial size 80 participants
Trial identifier NCT01967524, RC13_0061

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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
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).

Primary Outcomes

Measure
Evolution of the PGI-I (Patient Global Impression of Improvement)
time frame: 2 month

Secondary Outcomes

Measure
Evaluation of pain on digital scale (EN)
time frame: 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
time frame: 6 month
To assess the evolution of analgesics consumption (score MQS)
time frame: 6 month

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Jean-Jacques LABAT, Dr
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Nantes University Hospital.