Efficacy of High Intensity Laser for Provoked Vestibulodynia (Laser_RCT)

March 7, 2024 updated by: Université de Sherbrooke

Efficacy of High Intensity Laser Therapy for Reducing Pain During Intercourse in Women With Provoked Vestibulodynia: A Multicenter Randomized Controlled Trial

This is a multicenter randomized controlled trial (RCT) investigating the effects of laser treatments in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Following their enrollment in the study, participants will undergo a gynecological examination for confirmation of their diagnoses. Eligible participants will then be asked to complete a consent form and the baseline assessment. The baseline assessment consists of the completion of validated questionnaires (outcome measures). Participants will be randomized into the laser group or sham-laser group. The laser group will receive 12 sessions of active high intensity laser therapy (HILT) (30 minutes biweekly for 6 consecutive weeks). The sham-laser group will receive 12 sessions (30 minutes biweekly for 6 consecutive weeks) of laser therapy using a deactivated probe. Outcome measures (validated questionnaires) will also be assessed 2 weeks post-treatment as well as 6 months post-treatment (follow-up assessment).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Vulvodynia, a chronic vulvar pain condition, affects between 8 and 18% of reproductive-aged women. The main subtype of vulvodynia is provoked vestibulodynia (PVD), which is characterized by a sharp or burning pain at the vaginal opening while applying pressure to the vulvar vestibule or attempting vaginal penetration. Women suffering from PVD experience greater psychological distress, a worsened quality of life and overall well-being as well as sexual dysfunctions for both the women and their intimate partners. Women suffering from PVD have limited treatment options, and some women have persistent pain despite the available treatment options. Therefore, a new therapeutic avenue needs to be explored. High intensity laser therapy (HILT), a non-invasive and non-ablative laser technique, was found to be effective in several chronic pain conditions. Our randomized pilot study confirmed that HILT is feasible for treating PVD. The promising findings obtained provided support for conducting this large multicenter randomized controlled trial.

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Québec, Canada, G1V 4G2
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Québec - Université Laval
        • Contact:
      • Québec, Canada, G2B 3K3
        • Not yet recruiting
        • Kinatex l'Ormière
        • Contact:
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Centre Hospitalier Universitaire de Sherbrooke
        • Contact:
      • Sherbrooke, Quebec, Canada, J1L 1C6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Moderate to severe pain (≥ 5/10) at least 90% of the time during sexual intercourse or attempted sexual intercourse for at least 3 months
  • Provoked vestibulodynia of at least 3 months duration prior to the study and diagnosed by a standardized gynaecologic exam

Exclusion Criteria:

  • Other causes of vulvovaginal pain (e.g., spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvovaginal atrophy)
  • Post-menopausal state
  • Current pregnancy or pregnancy in the last year
  • Urogynecological condition (e.g., pelvic organ prolapse (POP) ≥ 3, urinary/vaginal infection active or in the last 3 months)
  • Anterior vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, corrective pelvic organ prolapse surgery)
  • Prior use of laser treatments for vulvar pain
  • Expected changes of medication that could influence pain perception (e.g., analgesic, antidepressant)
  • Other medical conditions that could interfere with the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Intensity Laser Therapy (HILT)
Active high intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)
Radiation: High Intensity Laser Therapy (HILT)
Nd:Yag 1064 nm pulsed high intensity laser will be applied to the vulvar area.
Other Names:
  • Nd:Yag laser
Sham Comparator: Sham High Intensity Laser Therapy
Sham high-intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)
Radiation: Sham High Intensity Laser Therapy
Nd:Yag 1064 pulsed high intensity laser deactivated probe will be applied to the vulvar area.
Other Names:
  • Control
  • Sham
  • Deactivated probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity during intercourse
Time Frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
To explore changes in pain intensity during intercourse (Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever)
Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain quality
Time Frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
To explore changes in the sensory, affective, and evaluative components of pain (McGill-Melzack Questionnaire). Minimum value: 0, Maximum value: 78, higher scores indicate a worse outcome (higher pain).
Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in sexual function
Time Frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
To explore changes in sexual function (Female Sexual Function Index - FSFI). Minimum value: 2, Maximum value: 36, lower scores indicate a worse outcome (low sexual function).
Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in sexual distress
Time Frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
To explore changes in sexual distress (Female Sexual Distress Scale - FSDS). Minimum value: 0, Maximum value: 52, higher scores indicate a worse outcome (higher sexually-related distress).
Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in pain catastrophizing
Time Frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
To explore changes in pain catastrophizing (Pain Catastrophizing Scale - PCS). Minimum value: 0, Maximum value: 52, higher scores indicate a worse outcome (higher pain catastrophizing).
Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in fear of pain
Time Frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
To explore changes in fear of pain (Pain Anxiety Symptoms Scale - PASS-20). Minimum value: 0, Maximum value: 100, higher scores indicate a worse outcome (higher fear of pain).
Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in cognitions regarding vaginal penetration
Time Frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
To explore the cognitions of women towards vaginal penetration (Vaginal penetration cognition questionnaire (VPCQ)). Minimum value: 0, Maximum value: 240, higher scores show higher levels of perceived penetration control.
Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in the life impact of pelvic pain
Time Frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
To explore the change in the life impact of pelvic pain (Pelvic Pain Impact Questionnaire). Minimum value: 0, Maximum value: 32, higher scores indicate that the pelvic pain of the participants has a strong impact on their life.
Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Change in intercourse self-efficacy
Time Frame: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
To explore the change self-efficacy regarding painful intercourse (Painful Intercourse Self-Efficacy Scale). Minimum value: 20, Maximum value: 100, higher scores indicate higher self-efficacy.
Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
Level of satisfaction with treatment
Time Frame: 2-week post-treatment evaluation, 6-months follow-up assessment
To determine acceptability by measuring the participants' satisfaction with the treatment on a Numeric Rating Scale (NRS) ranging from 0 (completely dissatisfied) to 10 (completely satisfied).
2-week post-treatment evaluation, 6-months follow-up assessment
Patient's global impression of change
Time Frame: 2-week post-treatment evaluation, 6-months follow-up assessment
To examine patient self-reported improvement (Patient's Global Impression of Change - PGIC) ranging from "very much worse" to "very much improved" on a 7-point scale.
2-week post-treatment evaluation, 6-months follow-up assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

CHU de Quebec-Universite Laval
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Exogenia
Kinatex l'Ormière

Investigators

  • Principal Investigator: Mélanie Morin, PT, PhD, Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2022

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

October 24, 2022

First Posted (Actual)

October 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-31-2023-4770

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Deidentified data will be made available upon approval by the principal investigator and study team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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