NCT06660212 Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health
| NCT ID | NCT06660212 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ottawa |
| Condition | Vulvodynia |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2025-03-17 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * gynaecologist cannot insert a single digit intravaginally and thus the participant would be unlikely able to tolerate the assessment procedures * other gynaecologic conditions such as lichen sclerosus, fissures, endometriosis, adenomyosis, or pelvic organ prolapse
Contact & Investigator
Linda McLean, PhD
PRINCIPAL INVESTIGATOR
University of Ottawa
Frequently Asked Questions
Who can join the NCT06660212 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Vulvodynia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06660212 currently recruiting?
Yes, NCT06660212 is actively recruiting participants. Contact the research team at Linda.Mclean@uottawa.ca for enrollment information.
Where is the NCT06660212 trial being conducted?
This trial is being conducted at Ottawa, Canada, Québec, Canada.
Who is sponsoring the NCT06660212 clinical trial?
NCT06660212 is sponsored by University of Ottawa. The principal investigator is Linda McLean, PhD at University of Ottawa. The trial plans to enroll 240 participants.