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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
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).
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).
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
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.
Time frame: 2 month
Evaluation of pain on digital scale (EN)
Evaluation of pain on digital scale (EN), each month after the injection
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
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