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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| botulinum toxin A + ropivacaïne | Experimental |
| |
| Ropivacaïne | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin A + ropivacaïne | Drug | D0 :
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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Jacques LABAT, Dr | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Axium | Aix-en-Provence | 13097 | France | |||
| Besançon University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31981833 | Derived | 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. |
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|
| Ropivacaïne | Drug | D0 :
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). |
|
| 6 month |
| To assess the evolution of analgesics consumption (score MQS) | 6 month |
| Besançon |
| 25030 |
| France |
| Clermont-Ferrand University Hospital | Clermont-Ferrand | 63003 | France |
| Nantes University Hospital | Nantes | 44093 | France |
| Rennes University Hospital | Rennes | 35033 | France |
| La Réunion University Hospital | Saint Denis de La Réunion | 97405 | France |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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