title: Efficacy of transcranial direct-current stimulation (tDCS) in women with provoked vestibulodynia: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Provoked vestibulodynia is the most common form of vulvodynia. Despite its high prevalence and deleterious sexual, conjugal, and psychological repercussions, effective evidence-based interventions for provoked vestibulodynia remain limited. For a high proportion of women, significant pain persists despite the currently available treatments. Growing evidence suggests that the central nervous system (CNS) could play a key role in provoked vestibulodynia; thus, treatment targeting the CNS, rather than localized dysfunctions, may be beneficial for women suffering from provoked vestibulodynia. In this study, we aim to build on the promising results of a previous case report and evaluate whether transcranial direct-current stimulation, a non-invasive brain stimulation technique targeting the CNS, could be an effective treatment option for women with provoked vestibulodynia.
  
  
  METHODS
  This single-center, triple-blind, parallel group, randomized, controlled trial aims to compare the efficacy of transcranial direct-current stimulation with sham transcranial direct-current stimulation in women with provoked vestibulodynia. Forty women diagnosed with provoked vestibulodynia by a gynecologist, following a standardized treatment protocol, are randomized to either active transcranial direct-current stimulation treatment for ten sessions of 20 minutes at an intensity of 2 mA or sham transcranial direct-current stimulation over a 2-week period. Outcome measures are collected at baseline, 2 weeks after treatment and at 3-month follow-up. The primary outcome is pain during intercourse, assessed with a numerical rating scale. Secondary measurements focus on the sexual function, vestibular pain sensitivity, psychological distress, treatment satisfaction, and the patient's global impression of change.
  
  
  CONCLUSIONS
  To our knowledge, this study is the first randomized controlled trial to examine the efficacy of transcranial direct-current stimulation in women with provoked vestibulodynia. Findings from this trial are expected to provide significant information about a promising intervention targeting the centralization of pain in women with provoked vestibulodynia.
  
  
  BACKGROUND
  Clinicaltrials.gov, NCT02543593 . Registered on September 4, 2015.
authors.affiliation: School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001 12th Avenue North, Sherbrooke, Québec, Canada.
authors.forename: Annie
authors.initials: A
authors.lastname: Morin
authors.affiliation: School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001 12th Avenue North, Sherbrooke, Québec, Canada.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Léonard
authors.affiliation: School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001 12th Avenue North, Sherbrooke, Québec, Canada.
authors.forename: Véronique
authors.initials: V
authors.lastname: Gougeon
authors.affiliation: Department of Obstetrics Gynecology, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001 12th Avenue North, Sherbrooke, Québec, Canada.
authors.forename: Guy
authors.initials: G
authors.lastname: Waddell
authors.affiliation: Department of Obstetrics Gynecology, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001 12th Avenue North, Sherbrooke, Québec, Canada.
authors.forename: Yves-André
authors.initials: YA
authors.lastname: Bureau
authors.affiliation: Department of Obstetrics Gynecology, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001 12th Avenue North, Sherbrooke, Québec, Canada.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Girard
authors.affiliation: School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001 12th Avenue North, Sherbrooke, Québec, Canada. melanie.m.morin@usherbrooke.ca.
authors.forename: Mélanie
authors.initials: M
authors.lastname: Morin
mesh_terms: D000293:Adolescent; D000328:Adult; D002490:Central Nervous System / Q000503:physiopathology*; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D008875:Middle Aged; D010147:Pain Measurement; D017060:Patient Satisfaction; D011792:Quebec; D012107:Research Design; D012725:Sexual Behavior; D011795:Surveys and Questionnaires; D013997:Time Factors; D065908:Transcranial Direct Current Stimulation / Q000009:adverse effects; D016896:Treatment Outcome; D014844:Vulva / Q000294:innervation*; D056650:Vulvodynia / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D055815:Young Adult
keywords: Chronic pain; Dyspareunia; Psychological distress; Randomized clinical trial; Sexual dysfunction; Transcranial direct-current stimulation; Treatment outcome; Vestibulodynia