Is Multimodal Physiotherapy And/or Photobiomodulation Therapy Effective for Pain Reduction Among Those Who Experience Provoked Vestibulodynia: a Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Motor Function Measurement Lab
RECRUITING
Ottawa
Bernard Lab
RECRUITING
Québec
Contact Information
Primary
Linda McLean, PhD
Linda.Mclean@uottawa.ca
613-562-5800
Backup
Regina Ding, PhD
rding@uottawa.ca
613-562-5800
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2028-11
Participants
Target number of participants: 240
Treatments
Sham_comparator: Sham laser
15 treatments will be provided over a 14 week period but at an intensity of 1% output for all sites and at all stages. Each treatment will last approximately 20 minutes. At each visit, the array will be applied to the surface of the perineum (red and infrared light), followed by treatment at specific painful sites using the red light probe.
Active_comparator: Real laser
15 treatments will be provided over a 14 week period. Each treatment will last approximately 20 minutes and will include the laser array first being applied to the surface of the perineum (red and infrared light) and the focal probe will be applied to painful sites on the perineum. All the stages will involve use of the same array and probe placement, but at each stage the dosage will be increased according to the BioFlex protocol.
Active_comparator: Sham laser + multi-modal physiotherapy
Over 14 weeks, participants will receive 10 physiotherapy sessions and 15 sham laser sessions, lasting a total of 50 minutes. Laser and physiotherapy treatments will be delivered within the same visit where possible. For the physiotherapy, the therapist will start with education, followed by progressive relaxation exercises and deep breathing. Participants will practice graded pelvic floor muscle (PFM) contractions, manual stretching techniques with external palpation, and gradually progressing to the insertion of one or two fingers into the vagina. Finally, vaginal dilators will be used to stretch the vaginal opening and PFMs. The participant will use relaxation breathing and contraction/relaxation cycles to facilitate insertion, progressing to larger dilators as tolerated. For the sham laser, the same protocol will be followed as described in previous arms.
Experimental: Laser + multi-modal physiotherapy
This treatment group will receive a combination therapy (i.e., both laser and physiotherapy), with each session lasting up to 50 minutes over a 14 week period. Laser and physiotherapy treatments will be delivered within the same visit where possible. Laser and physiotherapy protocols will be delivered as described in the previous arms.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), BioFlexTM Laser Therapy, University of Laval, Quebec City, Canada
Leads: University of Ottawa

This content was sourced from clinicaltrials.gov