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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
Sponsor: Nantes University Hospital
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2013-09
Completion Date
2016-08
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
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).
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).
Locations (6)
Clinique Axium
Aix-en-Provence, France
Besançon University Hospital
Besançon, France
Clermont-Ferrand University Hospital
Clermont-Ferrand, France
Nantes University Hospital
Nantes, France
Rennes University Hospital
Rennes, France
La Réunion University Hospital
Saint Denis de La Réunion, France