- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04502810
High-level Laser for Provoked Vestibulodynia
January 26, 2022 updated by: Mélanie Morin, Université de Sherbrooke
A Feasibility and Acceptability Study of High-level Laser for Women With Provoked Vestibulodynia
This is a randomized feasibility and acceptability study investigating the effects of laser treatment in women suffering from provoked vestibulodynia compared to a sham-laser treatment.
Participants will be randomized into the laser group or sham-laser group.
The laser group will receive 12 sessions of real high-level 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.
Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain, sexual function, sexual distress, psychological variables and perceived improvement after the treatment.
Study Overview
Study Type
Interventional
Enrollment (Actual)
41
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 Locations
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1H 5N4
- Centre hospitalier Universitaire de Sherbroke
-
-
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
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Moderate to severe pain (≥5/10) during sexual intercourse for at least 3 months
- Moderate to severe pain (≥5/10) in at least 90% of sexual intercourses or attempted sexual intercourse for at least 3 months
- Provoked vestibulodynia lasting at least 3 months prior to the study and diagnosed by a standardised gynaecologic exam
Exclusion Criteria:
- Other causes of vulvo-vaginal pain (e.g. spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
- Post-menopausal state
- Actual or past pregnancy in the last year
- Urogynecological condition (e.g. pelvic organs prolapse ≥3, urinary/vaginal infection active or in the last 3 months)
- Anterior vulvar, vaginal or pelvic surgery (e.g. vestibulectomy, corrective pelvic organs prolapses 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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High-level laser therapy
Real high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments)
|
Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.
Other Names:
|
Sham Comparator: Sham High-level laser therapy
Sham high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments)
|
Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence rate
Time Frame: 2-week post-treatment evaluation
|
To determine acceptability by assessing adherence to treatment sessions
|
2-week post-treatment evaluation
|
Level of satisfaction with the treatment
Time Frame: 2-week post-treatment evaluation
|
To determine acceptability by measuring the participants' satisfaction with the treatment on a numeric rating scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied)
|
2-week post-treatment evaluation
|
Willingness to recommend the treatment
Time Frame: 2-week post-treatment evaluation
|
To determine acceptability by assessing whether the participant would recommend the treatment.
|
2-week post-treatment evaluation
|
Rate of adverse events
Time Frame: 2-week post-treatment evaluation
|
To document any adverse events.
|
2-week post-treatment evaluation
|
Blinding effectiveness
Time Frame: 2-week post-treatment evaluation
|
To assess the feasibility of maintaining blinding to group allocation for the therapists, assessors and therapists.
Evaluated by asking the question: ''What treatment do you think you have received / given?
''
|
2-week post-treatment evaluation
|
Recruitment rate
Time Frame: Baseline to 2-week post-treatment evaluation
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To assess the recruitment rate including the barriers and reasons for refusing to participate as well as the reasons for exclusion
|
Baseline to 2-week post-treatment evaluation
|
Completion and dropout rates
Time Frame: 2-week post-treatment evaluation
|
To evaluate completion and dropout rates based on the completion of the post-treatment evaluation.
|
2-week post-treatment evaluation
|
Completeness of data
Time Frame: Baseline to 2-week post-treatment evaluation
|
To examine the percentage of completed outcome measures.
|
Baseline to 2-week post-treatment evaluation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain intensity during intercourse
Time Frame: Baseline to 2-week post-treatment evaluation
|
To explore changes in pain intensity during intercourse (Numerical Rating Scale, ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever)
|
Baseline to 2-week post-treatment evaluation
|
Change in sexual function
Time Frame: Baseline to 2-week post-treatment evaluation
|
To explore changes in sexual function (Female Sexual Function Index).
Minimum value: 2, Maximum value: 36 and lower scores mean worst outcome (low sexual function).
|
Baseline to 2-week post-treatment evaluation
|
Change in sexual distress
Time Frame: Baseline to 2-week post-treatment evaluation
|
To explore changes in sexual distress (Female Sexual Distress Scale ).
Minimum value: 0, Maximum value: 52, higher scores mean worst outcome (higher sexually related distress).
|
Baseline to 2-week post-treatment evaluation
|
Change in pain quality
Time Frame: Baseline to 2-week post-treatment evaluation
|
To explore changes on the sensory, affective and evaluative components of pain (McGill-Melzack Questionnaire).
Minimum value: 0, Maximum value: 78, higher scores mean worst outcome (higher pain).
|
Baseline to 2-week post-treatment evaluation
|
Patient's global impression of change
Time Frame: Baseline to 2-week post-treatment evaluation
|
To examine patient self-reported improvement (Patient's Global Impression of Change ranging from "very much worse" to "very much improved" on a 7-point scale.
|
Baseline to 2-week post-treatment evaluation
|
Change in fear of pain
Time Frame: Baseline to 2-week post-treatment evaluation
|
To explore changes in fear of pain (Pain Anxiety Symptoms Scale (PASS-20)).
Minimum value: 0, Maximum value: 100, higher scores mean worst outcome (higher fear of pain).
|
Baseline to 2-week post-treatment evaluation
|
Change in pain catastrophization
Time Frame: Baseline to 2-week post-treatment evaluation
|
To explore changes in pain catastrophization (Pain Catastrophizing Scale (PCS)).
Minimum value: 0, Maximum value: 52, higher scores mean worse outcome (higher pain catastrophization)
|
Baseline to 2-week post-treatment evaluation
|
Change in vulvar pain sensitivity
Time Frame: Baseline to 2-week post-treatment evaluation
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To explore changes in vulvar pain sensitivity (algometer)
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Baseline to 2-week post-treatment evaluation
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Change in vulvar blood circulation
Time Frame: Baseline to 2-week post-treatment evaluation
|
To explore changes in vulvar blood circulation using the laser speckle.
Vulvar vestibule blood perfusion is expressed in arbitrary perfusion units (APUs).
|
Baseline to 2-week post-treatment evaluation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 1, 2020
Primary Completion (Actual)
May 4, 2021
Study Completion (Actual)
May 4, 2021
Study Registration Dates
First Submitted
July 27, 2020
First Submitted That Met QC Criteria
August 3, 2020
First Posted (Actual)
August 6, 2020
Study Record Updates
Last Update Posted (Actual)
February 10, 2022
Last Update Submitted That Met QC Criteria
January 26, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #2020-3535
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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