High Intensity Laser Therapy for Vulvodynia
(Laser_RCT Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen byMélanie Morin, PT, PhD
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Université de Sherbrooke
No Placebo Group
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.
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.
12345What 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.
12356Eligibility 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
+5 more
Participant Groups
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.
2Treatment groups
Active Control
Placebo Group
Group I: High Intensity Laser Therapy (HILT)Active Control1 Intervention
Active high intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)
Group II: Sham High Intensity Laser TherapyPlacebo Group1 Intervention
Sham high-intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Centre Hospitalier Universitaire de Québec - Université LavalQuébec, Canada
Kinatex l'OrmièreQuébec, Canada
ExogeniaSherbrooke, Canada
Centre hospitalier universitaire de SherbrookeSherbrooke, Canada
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Who Is Running the Clinical Trial?
Université de SherbrookeLead Sponsor
Centre de recherche du Centre hospitalier universitaire de SherbrookeCollaborator
ExogeniaCollaborator
CHU de Quebec-Universite LavalCollaborator
Kinatex l'OrmièreCollaborator
References
High-Intensity Laser Therapy (HILT) as an Emerging Treatment for Vulvodynia and Chronic Musculoskeletal Pain Disorders: A Systematic Review of Treatment Efficacy. [2022]High-intensity laser therapy (HILT) has been gaining popularity in the treatment of chronic musculoskeletal pain, including vulvodynia. The objective of this study was to critically appraise and synthesize the available evidence on the efficacy of HILT for reducing pain and improving function in vulvodynia and other chronic primary musculoskeletal pain conditions. Electronic databases and the grey literature were searched. Effects on pain intensity, function, and adverse events were assessed. One study investigating HILT in the treatment of vulvodynia and 13 studies on the treatment of chronic musculoskeletal pain were selected. The study assessing vulvodynia showed favorable results for reducing pain. Regarding chronic musculoskeletal pain, 12 out of the 13 studies selected consistently showed that HILT was more effective than the placebo/active comparator for reducing pain and improving function. The available effect sizes for pain showed large to huge effects. Similar effects were observed for function except for two studies showing moderate effects. The GRADE score was moderate. Conclusions: There are insufficient data to support the use of HILT in vulvodynia, but the promising results encourage further research. HILT appears to be effective in musculoskeletal pain conditions. More high-quality studies are needed to identify effective laser protocols.
Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial. [2018]Low-level laser therapy (LLLT) is an emerging medical technology in which non-thermal laser irradiation is applied to treat pain. Because LLLT has been found effective in treating various pain syndromes without known side effects, we conducted a study evaluating the effect of LLLT on provoked vestibulodynia (PVD), a complex sexual pain disorder characterized by pain confined to the vulvar vestibule in response to contact or pressure.
Short-term Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis: A Prospective, Randomized, Controlled Study. [2023]The effectiveness of high-intensity laser therapy (HILT) has been demonstrated in some musculoskeletal repetitive strain injury disorders. This study aimed to determine the short-term effectiveness of HILT in de Quervain tenosynovitis (DQT).
Effectiveness of high-intensity laser therapy in the treatment of musculoskeletal disorders: A systematic review and meta-analysis of randomized controlled trials. [2020]Although high-intensity laser therapy (HILT) has been used for the management of musculoskeletal disorders (MSD), studies examining the effectiveness of HILT have been limited. We investigated the effectiveness of HILT in MSD using a systematic review and meta-analysis.
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]High-intensity laser therapy (HILT) has recently been used to control pain and symptom improvement in knee osteoarthritis. We performed a systematic review and meta-analysis of randomized controlled trials to assess the effectiveness of HILT in patients with knee osteoarthritis.
Pulsed high-intensity laser therapy versus low level laser therapy in the management of primary dysmenorrhea. [2021][Purpose] To determine the effect of pulsed high intensity laser therapy (HILT) versus low level laser therapy (LLLT) in the treatment of primary dysmenorrhea. [Participants and Methods] This was a randomized clinical trial that included 30 females diagnosed with primary dysmenorrhea who were assigned randomly into two groups of equal numbers. The treatment was three sessions every cycle for three consecutive cycles, where group (A) received pulsed HILT and group (B) received LLLT. All participants were evaluated before and after treatment sessions by visual analogue scale (VAS) and at the end of treatment by pain relief scale (PRS). [Results] The results showed a significant decrease in the severity of pain in the two groups. Comparison between the two groups showed a statistically non-significant difference in the severity of pain and pain alleviation at the end of the treatment course. [Conclusion] Both pulsed HILT and LLLT are effective in the treatment of primary dysmenorrhea, with no significant differences between the two modalities.