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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Myofascial Pelviperineal Pain

Intervention / Treatment
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* Drug: botulinum toxin A + ropivacaïne
* Drug: Ropivacaïne


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: botulinum toxin A + ropivacaïne<br> | Drug: botulinum toxin A + ropivacaïne<br>* 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).<br>|
| Active Comparator: Ropivacaïne<br> | Drug: Ropivacaïne<br>* 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).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myofascial pain, Perineal pain, Chronic pelvic pain, Botulinum toxin type A, Ropivacaïne