Interventions for managing pelvic health issues in women
Is Multimodal Physiotherapy and/or Photobiomodulation Therapy Effective for Pain Reduction Among Those Who Experience Provoked Vestibulodynia: a Randomized Controlled Trial
This study is testing whether light therapy and physical therapy can help women with vulvar pain feel better over 14 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Ottawa Academic / other |
| Locations | 2 sites (Ottawa, Ontario and 1 other locations) |
| Trial ID | NCT06660212 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of photobiomodulation (PBM) and multimodal physiotherapy (mPT) in managing pain associated with provoked vestibulodynia (PVD). Participants will be randomly assigned to one of four groups: PBM, sham PBM, PBM combined with mPT, or mPT with sham PBM. The study will assess changes in vulvar pain severity using the Vulvar Pain Assessment Questionnaire (VPAQ) over a 14-week intervention period. Given the high prevalence of PVD and its significant impact on women's health, this research seeks to provide evidence-based management strategies for this condition.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women over eighteen years old experiencing symptoms of provoked vestibulodynia.
Not a fit: Patients with other gynecologic conditions or those unable to tolerate intravaginal assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for women suffering from provoked vestibulodynia.
How similar studies have performed: While there is limited research specifically on this combination of interventions, the use of multimodal approaches in pelvic pain management has shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ottawa, Ontario and 1 other locations
- Motor Function Measurement Lab — Ottawa, Ontario, Canada (Recruiting)
- Bernard Lab — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Linda McLean, PhD — University of Ottawa
- Study coordinator: Linda McLean, PhD
- Email: Linda.Mclean@uottawa.ca
- Phone: 613-562-5800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.