Photobiomodulation + Physiotherapy for Vulvodynia

(BRIGHT Trial)

Recruiting at 1 trial location

Overseen by Stephanie Bernard, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Ottawa

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Linda McLean, PhD

Principal Investigator

University of Ottawa

Stephanie Bernard, PhD

Principal Investigator

University of Laval

Eligibility Criteria

This trial is for pre-menopausal, biologically born females over eighteen who can travel to Ottawa or Quebec City. They must not be pregnant or have given birth in the last six months and should experience symptoms of provoked vestibulodynia alone or with vaginismus.

Inclusion Criteria

I have not gone through menopause.

Willing to travel to Ottawa area or Quebec City area

I am a woman over 18 years old.

Exclusion Criteria

Gynaecologist cannot insert a single digit intravaginally and thus the participant would be unlikely able to tolerate the assessment procedures

I have a condition like endometriosis or pelvic organ prolapse.

Treatment Details

Interventions

• Multimodal physiotherapy (Behavioural Intervention)
• Photobiomodulation (Photobiomodulation)
• Sham photobiomodulation (Photobiomodulation)

Trial Overview The trial tests photobiomodulation (PBM) and multimodal physiotherapy (mPT) for managing vulvar pain during sexual/non-sexual activities. It includes four groups: PBM, sham PBM, PBM with mPT, and mPT with sham PBM to see which method works best alone or combined.

Participant Groups

Group I: Laser + multi-modal physiotherapy Experimental Treatment 2 Interventions

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.

Group II: Real laser Active Control 1 Intervention

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.

Group III: Sham laser + multi-modal physiotherapy Active Control 2 Interventions

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.

Group IV: Sham laser Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Ottawa

Lead Sponsor

Trials

231

Recruited

267,000+

University of Laval, Quebec City, Canada

Collaborator

Trials

1

Recruited

240+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

BioFlexTM Laser Therapy

Collaborator

Trials

2

Recruited

270+