Actively Recruiting
Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health
Led by University of Ottawa · Updated on 2026-05-05
240
Participants Needed
2
Research Sites
189 weeks
Total Duration
On this page
Sponsors
U
University of Ottawa
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to travel to Ottawa area or Quebec City area
- Biologically born female older than eighteen years
- Pre-menopausal
- Not currently pregnant or pregnancy/given birth in the past six months
- Experiencing signs and symptoms consistent with provoked vestibulodynia alone or provoked vestibulodynia plus vaginismus
You will not qualify if you...
- Gynaecologist cannot insert a single digit intravaginally, making assessment procedures unlikely to be tolerated
- Other gynaecologic conditions such as lichen sclerosus, fissures, endometriosis, adenomyosis, or pelvic organ prolapse
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Motor Function Measurement Lab
Ottawa, Ontario, Canada, K1S 1S2
Actively Recruiting
2
Bernard Lab
Québec, Quebec, Canada
Actively Recruiting
Research Team
L
Linda McLean, PhD
CONTACT
R
Regina Ding, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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