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| Name | Class |
|---|---|
| Centre de recherche du Centre hospitalier universitaire de Sherbrooke | OTHER |
| Exogenia | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-level laser therapy | Experimental | Real high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments) |
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| Sham High-level laser therapy | Sham Comparator | Sham high-level laser therapy laser 12 biweekly sessions (6 consecutive weeks of biweekly treatments) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-level laser therapy | Radiation | Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adherence rate | To determine acceptability by assessing adherence to treatment sessions | 2-week post-treatment evaluation |
| Level of satisfaction with the treatment | 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 | To determine acceptability by assessing whether the participant would recommend the treatment. | 2-week post-treatment evaluation |
| Rate of adverse events | To document any adverse events. | 2-week post-treatment evaluation |
| Blinding effectiveness | 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 | 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 | To evaluate completion and dropout rates based on the completion of the post-treatment evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity during intercourse | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mélanie Morin, PT, PhD | Université de Sherbrooke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier Universitaire de Sherbroke | Sherbrooke | Quebec | J1H 5N4 | Canada |
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| ID | Term |
|---|---|
| D056650 | Vulvodynia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Baseline evaluation - Randomization to real laser or sham laser (12 sessions in 6 consecutive weeks) - Post-treatment evaluation
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| 2-week post-treatment evaluation |
| Completeness of data | To examine the percentage of completed outcome measures. | 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 | 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 | 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 | 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 | 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 | 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 | To explore changes in vulvar pain sensitivity (algometer) | Baseline to 2-week post-treatment evaluation |
| Change in vulvar blood circulation | 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 |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |