Apply to Trial

Compensation: Varies

Number of Visits: 8

Duration: 14 weeks

240 Participants Needed

Photobiomodulation + Physiotherapy for Vulvodynia
(BRIGHT Trial)

Recruiting at 1 trial location

Overseen ByRegina Ding, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Ottawa

Disqualifiers: Lichen sclerosus, Endometriosis, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Photobiomodulation + Physiotherapy for Vulvodynia?

Research suggests that low-level laser therapy (a type of light therapy) can be effective in treating pain conditions like provoked vestibulodynia, which is similar to vulvodynia. Additionally, physiotherapy has been shown to help with vulvodynia, indicating that combining these treatments might be beneficial.¹ ² ³ ⁴ ⁵

Is photobiomodulation therapy safe for humans?

Photobiomodulation therapy, also known as low-level laser therapy, is generally considered safe for humans. It has been used for various conditions, including pain management and tissue healing, with studies showing it can reduce inflammation and promote healing without significant adverse effects.⁶ ⁷ ⁸ ⁹ ¹⁰

How is the Photobiomodulation + Physiotherapy treatment for vulvodynia different from other treatments?

This treatment is unique because it combines photobiomodulation (light therapy) and physiotherapy, which are non-invasive methods that aim to reduce pain without the side effects associated with drugs. Photobiomodulation uses light to promote healing and reduce pain, while physiotherapy involves physical techniques to improve function and relieve discomfort, offering a novel approach compared to traditional drug therapies or surgical options.¹ ⁵ ¹¹ ¹² ¹³

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.

See 2 more

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 14-week intervention involving photobiomodulation (PBM), multimodal physiotherapy (mPT), or a combination of both

14 weeks

Weekly visits for the first 8 weeks, then bi-weekly visits for mPT; 15 PBM sessions over 14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

Multimodal physiotherapy
Photobiomodulation
Sham 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

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Laser + multi-modal physiotherapyExperimental Treatment2 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 laserActive Control1 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 physiotherapyActive Control2 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 laserPlacebo Group1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Ottawa

Lead Sponsor

Trials

231

Recruited

267,000+

University of Laval, Quebec City, Canada

Collaborator

Trials

Recruited

240+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

BioFlexTM Laser Therapy

Collaborator

Trials

Recruited

270+

Findings from Research

In a pilot study involving 34 patients with provoked vestibulodynia (PVD), 78% of those receiving low-level laser therapy (LLLT) reported improvement in pain compared to 44% in the placebo group, indicating potential efficacy of LLLT for this condition.

No side effects were reported during the study, suggesting that LLLT is a safe treatment option; however, the study's small sample size and lack of improvement in other measurable outcomes highlight the need for larger trials to better understand its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial.Lev-Sagie, A., Kopitman, A., Brzezinski, A.[2018]

Photobiomodulation therapy is considered a safe treatment option that can influence inflammatory and immune responses.

This therapy not only helps in modulating these responses but also promotes metabolic processes that aid in the regeneration of damaged tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser oromaxillofacial photobiomodulation therapy: molecular mechanisms, outcomes and considerations.Fiani, B., Jarrah, R., Nathani, KR.[2022]

Photobiomodulation therapy, or laser therapy, uses red and near-infrared light to promote healing, alleviate pain, and decrease inflammation in veterinary medicine.

While there is growing evidence supporting its effectiveness for certain conditions, the results are mixed or limited for others, indicating that more research is needed to fully understand its applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation (Therapeutic Lasers): An Update and Review of Current Literature.Bunch, J.[2023]