Photobiomodulation + Physiotherapy for Vulvodynia

(BRIGHT Trial)

Recruiting at 2 trial locations

Overseen By Regina Ding, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Ottawa

Disqualifiers: Lichen sclerosus, Endometriosis, others

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

Compensation: Varies

Number of Visits: 8

Duration: 14 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to manage pain for individuals with provoked vestibulodynia (PVD), a common type of vulvovaginal pain. It tests the effectiveness of photobiomodulation (PBM), a light therapy, and multimodal physiotherapy (mPT) in reducing pain during activities like sex and exercise. Participants will receive one of four treatments: PBM, placebo PBM, a combination of PBM and mPT, or mPT with placebo PBM. Women with PVD symptoms who are pre-menopausal and willing to travel to Ottawa or Quebec City may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative pain management research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that photobiomodulation (PBM) is generally safe for treating pain, but limited information exists on its safety for vulvovaginal issues. Studies have not identified major side effects, but further research is necessary to confirm its safety for this specific use.

For multimodal physiotherapy, studies indicate it is effective and safe for individuals with chronic pelvic pain. It reduces pain with few side effects, and patients have tolerated it well. Additionally, it offers a comfortable setting for those anxious about treatment.

Overall, both treatments appear safe based on current research, but individual experiences may vary. Consulting a healthcare provider before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for vulvodynia because they combine innovative laser therapy with physiotherapy. Unlike standard treatments like medications or topical creams, photobiomodulation uses red and infrared light to target pain and inflammation directly, offering a non-invasive alternative. Additionally, the integration of multimodal physiotherapy, which includes progressive muscle exercises and relaxation techniques, aims to improve pelvic floor function more holistically. This dual approach not only targets the symptoms but also addresses underlying muscular issues, potentially offering more comprehensive relief.

What evidence suggests that this trial's treatments could be effective for managing vulvodynia?

In this trial, participants will receive different treatments to address vulvodynia. Research has shown that light therapy, known as photobiomodulation (PBM), reduces vulvar pain more effectively than placebo treatments. Specifically, PBM significantly eases pain in women with vulvar pain conditions. Some participants in this trial will receive real PBM, while others will receive sham PBM as a comparator. For multimodal physiotherapy (mPT), evidence suggests it improves muscle function and reduces pain more effectively than some standard treatments. It targets pelvic floor muscles, which often have increased tension in women with provoked vestibulodynia (PVD), helping to relieve pain. This trial will also test the combination of PBM and mPT, which might offer even better pain relief, as both treatments address different aspects of managing PVD. Early evidence suggests this combined approach could lead to greater improvements in pain and related symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Linda McLean, PhD

Principal Investigator

University of Ottawa

Stephanie Bernard, PhD

Principal Investigator

University of Laval

Are You a Good Fit for This Trial?

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

Not currently pregnant or pregnancy/given birth in the past six months

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Low-level laser therapy (LLLT) effectively reduces pain and promotes healing by using coherent light in the 600 to 1000 nm wavelength range, which triggers biochemical changes in cells and has been supported by numerous clinical and experimental studies.

LLLT has shown significant analgesic and anti-inflammatory effects, making it a promising complementary treatment option for managing symptoms in patients with osteoarthritis and chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. Dima, R., Tieppo Francio, V., Towery, C., et al.[2019]

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]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714415301245

Randomized clinical trial of multimodal physiotherapy ...

It has been reported that women with PVD have heightened PFM tone as well as inferior PFM strength, coordination and endurance compared to asymptomatic women [ ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32818475/

Multimodal physical therapy versus topical lidocaine for ...

The purpose of this study was to establish the efficacy of multimodal physical therapy compared with topical lidocaine, a frequently used first-line treatment.

3.

ajog.org

ajog.org/article/S0002-9378(24)00827-5/fulltext

a systematic review and meta-analysis

Meta-analyses revealed that multimodal physical therapy results in lower pain intensity compared to inert (eg, waitlist) or nonconservative (eg, ...

4.

dovepress.com

dovepress.com/multimodal-and-interdisciplinary-interventions-for-the-treatment-of-lo-peer-reviewed-fulltext-article-IJWH

Multimodal and Interdisciplinary Interventions for LPV | IJWH

To evaluate multimodal interventions specifically directed towards management of vulvodynia, this scoping review aims to synthesize literature ...

5.

contemporaryobgyn.net

contemporaryobgyn.net/view/multimodal-physical-therapy-proves-effective-for-women-with-chronic-pelvic-pain

Multimodal physical therapy proves effective for women ...

Relevant outcomes included sexual measures, pain outcomes, health-related quality of life, physical and psychological function, symptom severity ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12174717/

A scoping review of vulvodynia research: Diagnosis, treatment ...

A systematic review showed that multimodal physiotherapy, when compared with lidocaine treatment, is effective for improving pain and ...

7.

tandfonline.com

tandfonline.com/doi/full/10.1080/09593985.2023.2233600

Women's experiences of physical therapy treatment for ...

This study shows that the examination situation itself must be safe. It is important to bear in mind in that many women with vulvodynia have high anxiety before ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0002937824008275

Systematic Reviews Effectiveness of nonpharmacological ...

This systematic review with meta-analysis revealed that multimodal physical therapy is effective in women with chronic pelvic pain with a high certainty of ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4711364/

Multimodal nociceptive mechanisms underlying chronic pelvic ...

Both post-PPT pain (NRS 0–10) and duration were recorded to evaluate the safety and comfort of PPT testing. Post hoc, we recognized this recorded safety data is ...

10.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06981611

the Effect of Multimodal Treatment for Provoked Vulvodynia

The purpose of this project is to develop and evaluate a multimodal treatment for provoked vulvodynia, by addressing the following specific ...