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Botulinum toxin infiltrations versus local anaesthetic infiltrations in pelvic floor myofascial pain: Multicentre, randomized, double-blind study.
Levesque, Amélie; Ploteau, Stéphane; Michel, Fabrice; Siproudhis, Laurent; Bautrant, Eric; Eggermont, Julie; Rabischong, Benoit; Volteau, Christelle; Perrouin-Verbe, Marie-Aimée; Labat, Jean-Jacques.
Afiliación
  • Levesque A; Urology Department, Federative Pelvic Pain Center, Nantes University Hospital, 44093 Nantes, France. Electronic address: amelie.levesque@chu-nantes.fr.
  • Ploteau S; Department of Gynecology-Obstetrics and Reproductive Medicine, Federative Pelvic Pain Center, 44000 Nantes University Hospital, Nantes, France.
  • Michel F; Physical Medicine and Rehabilitation Department, CHU Jean Minjoz, 25000 Besançon, France.
  • Siproudhis L; Department of Gastroenterology, University Hospital of Rennes, 35000 Pontchaillou, France.
  • Bautrant E; Pelvi-Perineal Surgery and Rehabilitation Department, Private Medical Centre "l'Avancée-Clinique Axium", 13100 Aix-en-Provence, France.
  • Eggermont J; Department of Gynecology-Obstetrics, University Hospital Felix Guyon, 97400 Saint-Denis, Reunion.
  • Rabischong B; Department of Gynecology-Obstetrics, University Hospital Estaing, 63003 Clermont Ferrand, France.
  • Volteau C; Methodology and Biostatistics Platform, Nantes University Hospital, 44000 Nantes, France.
  • Perrouin-Verbe MA; Urology Department, Federative Pelvic Pain Center, Nantes University Hospital, 44093 Nantes, France.
  • Labat JJ; Urology Department, Federative Pelvic Pain Center, Nantes University Hospital, 44093 Nantes, France.
Ann Phys Rehabil Med ; 64(1): 101354, 2021 Jan.
Article en En | MEDLINE | ID: mdl-31981833
BACKGROUND: Many studies have demonstrated a link between pelvic floor myofascial syndromes and chronic pelvic pain. Botulinum toxin has been extensively used for several years in the field of pain, especially due to its action on muscle spasm. However, the efficacy of botulinum toxin in the context of chronic pelvic pain remains controversial. OBJECTIVES: This multicentre, randomized, controlled, double-blind study was designed to compare the efficacy of botulinum toxin and local anaesthetic (LA) injection versus LA injection alone for pelvic floor myofascial syndrome and chronic pelvic pain. METHODS: According to the number of painful trigger points detected on physical examination, patients received from 1 to 4 injections of botulinum toxin with LA (BTX) or LA alone. The primary endpoint was Patient Global Impression of Improvement (PGI-I) score on day 60 after infiltration. Secondary endpoints were pain intensity, number of painful trigger points on palpation, analgesic drug consumption and quality of life. RESULTS: We included 80 patients, 40 in each group. This study failed to demonstrate a significant difference between the 2 groups on day 60 in the primary endpoint or secondary endpoints (PGI-I score≤2=20% [LA] versus 27.5% [BTX], P=0.43). However, both groups showed significant alleviation of global pain. CONCLUSION: This study does not justify the use of botulinum toxin in the context of chronic pelvic pain with myofascial syndrome but does justify muscle injections with LA alone. ClinicalTrials.gov: NCT01967524.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diafragma Pélvico / Toxinas Botulínicas Tipo A / Manejo del Dolor / Anestésicos Locales / Fármacos Neuromusculares Tipo de estudio: Clinical_trials Aspecto: Patient_preference Límite: Humans Idioma: En Revista: Ann Phys Rehabil Med Asunto de la revista: MEDICINA FISICA / REABILITACAO Año: 2021 Tipo del documento: Article Pais de publicación: Países Bajos
Texto completo
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Imprimir
XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diafragma Pélvico / Toxinas Botulínicas Tipo A / Manejo del Dolor / Anestésicos Locales / Fármacos Neuromusculares Tipo de estudio: Clinical_trials Aspecto: Patient_preference Límite: Humans Idioma: En Revista: Ann Phys Rehabil Med Asunto de la revista: MEDICINA FISICA / REABILITACAO Año: 2021 Tipo del documento: Article Pais de publicación: Países Bajos