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Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health

Study acronym: BRIGHT
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study Identification, Study Status, Oversightv4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2024 to Mar 17, 2025
    • Study description shortened, about 6 words
    • Site details revised at 2 of 2 sites
    v3
  3. Minor Secondary endpoints: details revised at 8 of 39 entries
    • Study description shortened, about 120 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This trial will provide evidence for the effective management of pain and pain-related domains among those who experience provoked vestibulodynia (PVD) using photobiomodulation (PBM) and multimodal physiotherapy (mPT) in a randomized controlled trial (RCT). PVD is the most common subcategory of vulvovaginal pain experienced during sexual and non-sexual activities, affects the psychological and sexual health of an astounding one in five Canadian women, yet access to evidence-informed management approaches is limited. We will employ four intervention groups: PBM, sham PBM (control), PBM combined with mPT, and mPT with sham PBM to evaluate the effectiveness of each approach on its own and the two approaches in combination. Among those who experience PVD, we seek to answer: 1. Relative to baseline and to sham PBM, does a 14-week intervention involving PBM, mPT, or a combination of mPT and PMB reduce vulvar pain severity reported on the Vulvar Pain Assessment Questionnaire (VPAQ)? 2. Is a combined mPT and PBM intervention more effective than mPT or PMB alone when considering vulvar pain severity and/or related domains as measured through VPAQ? 3. Are positive changes in vulvar pain severity and related domains observed following a 14-week intervention involving PBM, mPT or a combination of PBM and mPT retained at 6 months and at 1 year? Secondary objectives include determining the effectiveness of PBM, mPT, and mPT combined with PBM relative to sham PBM on: Patient Global Impression of Change (PGIC), pain sensitivity measured using provocative tests, the other domains of the VPAQ, sexual function, as well as investigating mediating effects of psychosocial variables (central sensitization index, chronic pain acceptance), gender identity, and the presence of vaginismus on patient response to mPT, PBM and mPT combined with PBM. Lastly we will monitor patient satisfaction with the interventions, adherence to the interventions, and any adverse events.
Trial Details
NCT Number NCT06660212
Lead Sponsor University of Ottawa
Collaborators: Canadian Institutes of Health Research (CIHR), University of Laval, Quebec City, Canada, BioFlexTM Laser Therapy
Conditions
(from sponsor)
Vulvodynia, Provoked Vestibulodynia, Dyspareunia
Related terms Dyspareunia, Vulvodynia
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov