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

Trial Summary

What is the purpose of this trial?

This trial is testing a powerful laser treatment to help women with a specific type of chronic vaginal pain. The laser aims to reduce pain and improve their quality of life by using focused light energy. Laser therapy has shown promise in treating similar conditions, with benefits lasting for an extended period.

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 data supports the idea that High Intensity Laser Therapy for Vulvodynia is an effective treatment?

The available research shows that High Intensity Laser Therapy (HILT) has shown promising results in reducing pain for vulvodynia, although there is not enough data to fully support its use for this condition yet. However, HILT has been more thoroughly studied for other types of chronic pain, like musculoskeletal pain, where it has been found to be more effective than a placebo in reducing pain and improving function. This suggests that HILT could potentially be effective for vulvodynia as well, but more research is needed to confirm this. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment High Intensity Laser Therapy (HILT) for vulvodynia?

Research shows that High Intensity Laser Therapy (HILT) is effective in reducing pain and improving function in chronic musculoskeletal pain conditions, and one study on vulvodynia showed favorable results for pain reduction. However, more high-quality studies are needed to confirm its effectiveness specifically for vulvodynia. ^{1 2 3 4 5}

What safety data exists for high-intensity laser therapy for vulvodynia?

The systematic review on high-intensity laser therapy (HILT) for vulvodynia and chronic musculoskeletal pain disorders found promising results for reducing pain in vulvodynia, but noted insufficient data to fully support its use. The review did not specifically mention adverse events, suggesting that more high-quality studies are needed to establish safety and effective protocols. Other studies on HILT for different conditions, like musculoskeletal pain and dysmenorrhea, did not report significant safety concerns, indicating it may be generally safe, but specific safety data for vulvodynia is limited. ^{1 2 3 5 6}

Is High Intensity Laser Therapy (HILT) safe for humans?

High Intensity Laser Therapy (HILT) has been used in studies for conditions like chronic musculoskeletal pain and primary dysmenorrhea, showing effectiveness in reducing pain without significant adverse effects reported. However, more high-quality studies are needed to confirm its safety and effectiveness, especially for vulvodynia. ^{1 2 3 5 6}

Is High Intensity Laser Therapy (HILT) a promising treatment for vulvodynia?

High Intensity Laser Therapy (HILT) shows promise in reducing pain for vulvodynia, based on one study with positive results. However, more research is needed to confirm its effectiveness. ^{1 2 3 5 6}

How is high-intensity laser therapy (HILT) different from other treatments for vulvodynia?

High-intensity laser therapy (HILT) is unique because it uses powerful laser light to reduce pain and improve function, which is different from traditional treatments like medication or physical therapy. While it shows promise in treating vulvodynia and other pain conditions, more research is needed to confirm its effectiveness specifically for vulvodynia. ^{1 2 3 5 6}

Research Team

Mélanie Morin, PT, PhD

Principal Investigator

Université de Sherbrooke

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Switzerland 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. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. Turkey pubmed.ncbi.nlm.nih.gov

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

4. United States 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. [2020]

5. Netherlands 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. [2021]

6. Japan pubmed.ncbi.nlm.nih.gov

Pulsed high-intensity laser therapy versus low level laser therapy in the management of primary dysmenorrhea. [2021]