title: Randomized clinical trial of multimodal physiotherapy treatment compared to overnight lidocaine ointment in women with provoked vestibulodynia: Design and methods.
abstract: Provoked vestibulodynia (PVD) is a highly prevalent and debilitating condition yet its management relies mainly on non-empirically validated interventions. Among the many causes of PVD, there is growing evidence that pelvic floor muscle (PFM) dysfunctions play an important role in its pathophysiology. Multimodal physiotherapy, which addresses these dysfunctions, is judged by experts to be highly effective and is recommended as a first-line treatment. However, the effectiveness of this promising intervention has been evaluated through only two small uncontrolled trials. The proposed bi-center, single-blind, parallel group, randomized controlled trial (RCT) aims to evaluate the efficacy of multimodal physiotherapy and compare it to a frequently used first-line treatment, topical overnight application of lidocaine, in women with PVD. A total of 212 women diagnosed with PVD according to a standardized protocol were eligible for the study and were randomly assigned to either multimodal physiotherapy or lidocaine treatment for 10weeks. The primary outcome measure is pain during intercourse (assessed with a numerical rating scale). Secondary measures include sexual function, pain quality, psychological factors (including pain catastrophizing, anxiety, depression and fear of pain), PFM morphology and function, and patients' global impression of change. Assessments are made at baseline, post-treatment and at the 6-month follow-up. This manuscript presents and discusses the rationale, design and methodology of the first RCT investigating physiotherapy in comparison to a commonly prescribed first-line treatment, overnight topical lidocaine, for women with PVD.
authors.affiliation: School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke and Research Center of the Centre hospitalier universitaire de Sherbrooke (CHUS), Sherbrooke, QC, Canada. Electronic address: melanie.m.morin@usherbrooke.ca.
authors.forename: Mélanie
authors.initials: M
authors.lastname: Morin
authors.affiliation: School of Rehabilitation, Faculty of Medicine, Université de Montréal and Research Center of the Institut de gériatrie de Montréal, Montréal, QC, Canada.
authors.forename: Chantale
authors.initials: C
authors.lastname: Dumoulin
authors.affiliation: Department of Psychology, University de Montréal, Montréal, QC, Canada.
authors.forename: Sophie
authors.initials: S
authors.lastname: Bergeron
authors.affiliation: Departments of Obstetrics and Gynecology and Social and Preventive Medicine, Université de Montréal and Research Center of the Centre hospitalier de l'Université de Montréal, Montréal, QC, Canada.
authors.forename: Marie-Hélène
authors.initials: MH
authors.lastname: Mayrand
authors.affiliation: Jewish General Hospital and Royal Victoria Hospital, McGill University Health Center, Montréal, QC, Canada.
authors.forename: Samir
authors.initials: S
authors.lastname: Khalifé
authors.affiliation: Department of Obstetrics and Gynecology, CHUS and Université de Sherbrooke, Sherbrooke, QC, Canada.
authors.forename: Guy
authors.initials: G
authors.lastname: Waddell
authors.affiliation: Research Center on Aging, Université de Sherbrooke, Sherbrooke, QC, Canada.
authors.forename: Marie-France
authors.initials: MF
authors.lastname: Dubois
mesh_terms: D000046:Academic Medical Centers; D000287:Administration, Topical; D000328:Adult; D000779:Anesthetics, Local / Q000627:therapeutic use*; D001007:Anxiety / Q000523:psychology; D058443:Catastrophization / Q000523:psychology; D003863:Depression / Q000523:psychology; D005260:Female; D006801:Humans; D008012:Lidocaine / Q000627:therapeutic use*; D026741:Physical Therapy Modalities; D012735:Sexual Dysfunction, Physiological / Q000523:psychology / Q000628:therapy*; D016037:Single-Blind Method; D016896:Treatment Outcome; D056650:Vulvodynia / Q000523:psychology / Q000628:therapy*; D055815:Young Adult
chemical_list: D000779:Anesthetics, Local; D008012:Lidocaine
keywords: Dyspareunia; Lidocaine; Pelvic floor muscles; Physical therapy; Provoked vulvodynia