High Intensity Laser Therapy for Vulvodynia

(Laser_RCT Trial)

Recruiting at 3 trial locations

Overseen By Camille Simard, MSc

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Must not be taking: Analgesics, Antidepressants

Disqualifiers: Post-menopausal, Pregnancy, Urogynecological, Surgery, others

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

Compensation: Varies

Number of Visits: 16

Duration: 6 weeks

142 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether high-intensity laser therapy (HILT) can help women with provoked vestibulodynia, a condition causing pain during sex. Researchers will compare real laser treatments to sham ones to determine the treatment's effectiveness. Women who have experienced moderate to severe pain during sex for at least three months may qualify. Participants will receive 12 sessions over six weeks and will be evaluated again two weeks and six months after the treatment. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but it excludes participants who expect changes in medication that could influence pain perception, like analgesics or antidepressants.

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

The trial protocol does not specify if you need to stop your current medications, but it excludes those expecting changes in medications that could affect pain perception, like painkillers or antidepressants.

What prior data suggests that this laser therapy is safe for treating vulvodynia?

Research has shown that High Intensity Laser Therapy (HILT) is generally easy for patients to handle. Other studies using HILT for conditions like muscle and joint pain or menstrual pain found no major safety issues. This suggests that HILT might also be safe for treating vulvodynia.

Specifically, among those who received HILT for vestibulodynia, 68% reported less pain, and 63% expressed satisfaction with the treatment. While these results primarily demonstrate its effectiveness, they also indicate that the treatment doesn't cause major issues for most people. This is encouraging for anyone considering joining a trial involving HILT. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about High Intensity Laser Therapy (HILT) for vulvodynia because it offers a non-invasive treatment option that targets pain directly. Unlike the common treatments such as medications, physical therapy, or nerve blocks, HILT uses concentrated laser energy to potentially reduce pain and inflammation without the need for drugs. This novel approach could provide faster relief with fewer side effects, making it a promising alternative for those who haven't found success with traditional methods.

What evidence suggests that High Intensity Laser Therapy might be an effective treatment for vulvodynia?

Research has shown that High Intensity Laser Therapy (HILT), one of the treatments under study in this trial, can help reduce pain in women with provoked vestibulodynia, a type of long-lasting pain in the vulva area. Studies have found that HILT is not only feasible but also well-received for treating this condition. In one study, women experienced significant pain relief after HILT sessions. This trial will compare HILT with Sham High Intensity Laser Therapy, which serves as a placebo control. Overall, evidence suggests that HILT could be an effective option for those dealing with this ongoing discomfort. ^{1 2 6 7 8}

Who Is on the Research Team?

Mélanie Morin, PT, PhD

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

This trial is for women who've had provoked vestibulodynia, a type of vulvar pain, for at least 3 months. They should feel moderate to severe pain during sexual activities most of the time. Women with certain urogynecological conditions, other causes of vulvovaginal pain, recent pregnancies or surgeries in the area, or those using medications affecting pain perception are not eligible.

Inclusion Criteria

I have been diagnosed with provoked vestibulodynia for at least 3 months.

I experience significant pain during sex, rating it 5 or higher out of 10.

Exclusion Criteria

I have had laser treatments for vulvar pain before.

I have gone through menopause.

Other medical conditions that could interfere with the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete validated questionnaires and undergo a gynecological examination for confirmation of their diagnoses

1 week

1 visit (in-person)

Treatment

Participants receive 12 sessions of either active high intensity laser therapy or sham-laser treatment, 30 minutes biweekly for 6 consecutive weeks

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 2 weeks and 6 months post-treatment

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• High Intensity Laser Therapy (HILT)
• Sham High Intensity Laser Therapy

Trial Overview The study compares High Intensity Laser Therapy (HILT) with a sham treatment to see which is more effective for reducing vulvar pain. Participants will be randomly assigned to receive either real laser therapy or a placebo-like inactive laser in biweekly sessions over six weeks.

How Is the Trial Designed?

Group I: High Intensity Laser Therapy (HILT) Active Control 1 Intervention

Active high intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)

Group II: Sham High Intensity Laser Therapy Placebo Group 1 Intervention

Sham high-intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborator

Trials

64

Recruited

33,600+

Exogenia

Collaborator

Trials

2

Recruited

180+

CHU de Quebec-Universite Laval

Collaborator

Trials

177

Recruited

110,000+

Kinatex l'Ormière

Collaborator

Trials

1

Recruited

140+

Published Research Related to This Trial

High-intensity laser therapy (HILT) shows promising results in reducing pain for vulvodynia, but the evidence is still insufficient to fully support its use in this condition, based on one study.

In the treatment of chronic musculoskeletal pain, HILT was found to be more effective than placebo in 12 out of 13 studies, demonstrating large to huge effects on pain reduction and improvement in function, indicating its potential as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Laser Therapy (HILT) as an Emerging Treatment for Vulvodynia and Chronic Musculoskeletal Pain Disorders: A Systematic Review of Treatment Efficacy. Starzec-Proserpio, M., Grigol Bardin, M., Fradette, J., et al.[2022]

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]

A randomized clinical trial with 30 females suffering from primary dysmenorrhea found that both pulsed high intensity laser therapy (HILT) and low level laser therapy (LLLT) significantly reduced pain severity after treatment.

There was no significant difference in pain relief between the two therapies, indicating that both methods are effective options for managing primary dysmenorrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed high-intensity laser therapy versus low level laser therapy in the management of primary dysmenorrhea. Thabet, AA., Ebid, AA., El-Boshy, ME., et al.[2021]

High-intensity laser therapy (HILT) significantly reduces pain in knee osteoarthritis patients, with a mean difference of -1.18 on the Visual Analog Scale (VAS) compared to control groups, based on data from 334 patients across four studies.

HILT also improves stiffness and function in knee osteoarthritis, showing a standardized mean difference of -1.00 for stiffness and -5.36 for functional outcomes, indicating its potential as an effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of high-intensity laser therapy in the management of patients with knee osteoarthritis: A systematic review and meta-analysis of randomized controlled trials. Song, HJ., Seo, HJ., Kim, D.[2021]

High-intensity laser therapy (HILT) significantly improved hand grip strength and reduced pain levels in patients with de Quervain tenosynovitis after 5 weeks of treatment, compared to a sham therapy group.

The study involved 64 patients, and both groups showed improvements, but the HILT group had notably better outcomes, demonstrating its effectiveness as a non-invasive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis: A Prospective, Randomized, Controlled Study. Dundar Ahi, E., Sirzai, H.[2023]

High-intensity laser therapy (HILT) significantly reduces pain and improves disability in patients with musculoskeletal disorders, based on a systematic review of 12 studies involving 736 patients.

The most notable improvements were observed in neck pain, with a mean difference of -1.02, indicating that HILT is particularly effective for this condition compared to control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of high-intensity laser therapy in the treatment of musculoskeletal disorders: A systematic review and meta-analysis of randomized controlled trials. Song, HJ., Seo, HJ., Lee, Y., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05597358

Efficacy of High Intensity Laser for Provoked Vestibulodynia This is a multicenter randomized controlled trial (RCT) investigating the effects of laser treatments in women suffering from provoked vestibulodynia ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S174360952201325X

A Randomized Prospective Pilot Study Investigating the ... HILT is a feasible and acceptable intervention to treat women with PVD. With the significant improvements observed, findings support conducting a randomized ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9267539/

High-Intensity Laser Therapy (HILT) as an Emerging ... The study assessing vulvodynia showed favorable results for reducing pain. Regarding chronic musculoskeletal pain, 12 out of the 13 studies selected ...

4. ics.org ics.org/2022/abstract/411

Feasibility, acceptability and effects of high intensity laser ... Feasibility, acceptability and effects of high intensity laser therapy for women with vulvodynia: a randomized prospective pilot study.

5. ctv.veeva.com ctv.veeva.com/study/efficacy-of-high-intensity-laser-for-provoked-vestibulodynia

Efficacy of High Intensity Laser for Provoked Vestibulodynia This is a multicenter randomized controlled trial (RCT) investigating the effects of laser treatments in women suffering from provoked ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1743609517314145

Low-Level Laser Therapy for the Treatment of Provoked ... In the clinical pain report at study completion, 14 of 18 patients (78%) receiving LLLT reported improvement compared with 7 of 16 (44%) in the placebo group (P ...

7. withpower.com withpower.com/trial/phase-vulvar-vestibulitis-10-2022-d84c8

High Intensity Laser Therapy for Vulvodynia (Laser_RCT Trial) Other studies on HILT for different conditions, like musculoskeletal pain and dysmenorrhea, did not report significant safety concerns, indicating it may be ...

8. academic.oup.com academic.oup.com/jsm/article/22/4/579/8010870

Photobiomodulation therapy for the treatment of vulvar pain ... To determine whether a 15-session photobiomodulation (PBM) intervention is more effective than sham-PBM for reducing vulvar pain.