Is Multimodal Physiotherapy andor Photobiomodulation Therapy Effective for Pain Reduction Among Those Who Experience Provoked Vestibulodynia a Randomized Controlled Trial
Led by University of Ottawa · Updated on 2026-05-05
240
Participants Needed
2
Research Sites
56 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the management of provoked vestibulodynia PVD, a common type of vulvovaginal pain affecting many women during sexual and non-sexual activities. This trial is a randomized controlled study comparing the effectiveness of photobiomodulation PBM, multimodal physiotherapy mPT, and their combination to reduce pain severity and improve related symptoms. The study aims to provide evidence on pain reduction and patient outcomes over time, including follow-ups at 6 months and 1 year.
Participants will be randomly assigned to one of four groups sham PBM control, real PBM, mPT with sham PBM, and mPT combined with real PBM. The PBM treatment uses a laser system delivering red and infrared light progressively over 15 sessions in 14 weeks, with treatment lasting about 20 minutes each. The mPT involves 10 physiotherapy sessions focusing on education, relaxation, pelvic floor muscle exercises, manual techniques, and vaginal dilator use. Those in combination groups receive both treatments during the same visits. Participants are asked to avoid vaginal penetration during the first 8 weeks.
During the study, participants will attend regular treatment sessions and complete assessments including pain questionnaires, sensitivity tests, and sexual function evaluations. Pain severity will be measured at baseline, after treatment, and at 6 and 12 months. Adherence to home exercises and any side effects will be monitored. The study includes close safety oversight, and participants in the sham PBM group will have the option to receive real PBM after the study ends.
CONDITIONS
Brief Title
Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health
Research Team
L
Linda McLean, PhD
R
Regina Ding, PhD
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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 unlikely to be tolerated
Presence of other gynecologic conditions such as lichen sclerosus, fissures, endometriosis, adenomyosis, or pelvic organ prolapse
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 14 weeks
Participants receive up to 15 photobiomodulation (laser) treatments over 14 weeks, with sessions lasting approximately 20 minutes. Those assigned to multimodal physiotherapy (mPT) will attend 10 physiotherapy sessions over 14 weeks, lasting about 45 minutes each. For participants receiving both interventions, laser and physiotherapy sessions will be coordinated within the same visits where possible. During the first 8 weeks, participants are asked to avoid vaginal penetrative activities. After 8 weeks, they may resume penetrative activities cautiously as tolerated.
Weekly photobiomodulation visits for the first 8 weeks, then additional sessions to complete 15 treatments; multimodal physiotherapy visits weekly for 8 weeks then every two weeks for 2 sessions, totaling 10 sessions
Follow-up
Duration - Up to 12 months
Participants are monitored for outcomes and safety after completing the intervention, with assessments at 2 weeks, 6 months, and 12 months post intervention start.
Visits at approximately 2 weeks, 6 months, and 12 months after intervention start
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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Published Research Related To This Trial
A randomized comparison of group cognitive--behavioral therapy, surface electromyographic biofeedback, and vestibulectomy in the treatment of dyspareunia resulting from vulvar vestibulitis.
Sophie Bergeron, Yitzchak M Binik, Samir Khalifé...