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Study identifier: NCT06660212 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health

Condition: Vulvodynia · Provoked Vestibulodynia · Dyspareunia  ·  Sponsor: University of Ottawa

PhaseNA
Planned participants240
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 Impre…

This description comes directly from the study's public registry record.

Talk to the study team

Linda McLean, PhD  ·  613-562-5800  ·  Linda.Mclean@uottawa.ca

Regina Ding, PhD  ·  613-562-5800  ·  rding@uottawa.ca

Always discuss trial participation with your own doctor first.

Locations (2)

Motor Function Measurement LabOttawa, Ontario, CanadaRecruiting
Bernard LabQuébec, Quebec, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT06660212