Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06660212

Is Multimodal Physiotherapy and/or 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

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

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

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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

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

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Research Team

L

Linda McLean, PhD

R

Regina Ding, PhD

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

The Vulvar Pain Assessment Questionnaire: Factor Structure, Preliminary Norms, Internal Consistency, and Test-Retest Reliability.

Emma Dargie, Ronald R Holden, Caroline F Pukall

https://pubmed.ncbi.nlm.nih.gov/29198513

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...

https://pubmed.ncbi.nlm.nih.gov/11275387

Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial.

Ahinoam Lev-Sagie, Asia Kopitman, Amnon Brzezinski

https://pubmed.ncbi.nlm.nih.gov/28970071

Provoked Vestibulodynia: Diagnosis, Self-Reported Pain, and Presentation During Gynaecological Examinations.

Emma E Dargie, Susan M Chamberlain, Caroline F Pukall

https://pubmed.ncbi.nlm.nih.gov/28343555

Morphometry of the pelvic floor muscles in women with and without provoked vestibulodynia using 4D ultrasound.

Mélanie Morin, Sophie Bergeron, Samir Khalifé...

https://pubmed.ncbi.nlm.nih.gov/24344835

Pelvic floor muscle assessment outcomes in women with and without provoked vestibulodynia and the impact of a physical therapy program.

Evelyne Gentilcore-Saulnier, Linda McLean, Corrie Goldfinger...

https://pubmed.ncbi.nlm.nih.gov/20059663