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| Name | Class |
|---|---|
| Centre de recherche du Centre hospitalier universitaire de Sherbrooke | OTHER |
| Cigonia | UNKNOWN |
| CHU de Quebec-Universite Laval | OTHER |
| Kinatex l'Ormière |
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Chronic vulvar pain is a highly prevalent and debilitating condition affecting up to 16% of women. The most common subtype of vulvar pain, provoked vestibulodynia (PVD), is characterized by a sharp pain at the entry of the vagina in response to pressure or attempted vaginal penetration. Women with PVD not only present with psychological distress and significant disruption in all aspects of sexual function, but they are also confronted with limited effective treatment options. Dry needling (DN) could fill this therapeutic gap. Similar to acupuncture, this approach involves the insertion of fine needles into the tissues. However, its mechanisms of action are quite different. DN specifically targets muscle tension/stiffness, which has been shown to play a key role in PVD. After designing a DN treatment protocol tailored to the affected muscles in PVD, our randomized pilot study confirmed that our state-of-the-art DN treatment protocol is feasible and acceptable for treating PVD and the promising findings obtained provide support for conducting the proposed large-scale study.
The proposed multicenter randomized controlled trial aims to establish the efficacy of DN for reducing pain in women with PVD. Women will be randomized to receive either sham or real DN for 8 weekly sessions. Validated outcome measures will be assessed at baseline, post-treatment and at the 6-month follow-up.
The current proposal addresses the urgent need to develop novel treatment options for women with PVD. If proven effective, DN could be proposed as a first-line low-risk treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real dry needling | Experimental | Real dry needling, i.e., penetrating needles, for 8 consecutive weekly sessions. |
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| Sham dry needling | Sham Comparator | Sham dry needling, i.e., non-penetrating needles, for 8 consecutive weekly sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real dry needling | Other | The intervention will consist of real dry needling applied to the pelvic floor, hip, and lower back muscles, accompanied by an education component, delivered over eight consecutive weekly sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity during intercourse | To assess 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-month follow-up assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain quality | To assess changes in the sensory, affective, and evaluative components of pain (McGill-Melzack Questionnaire). Minimum value: 0, Maximum value: 77, higher scores indicate a worse outcome (higher pain). | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment |
| Change in sexual function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camille Simard, MSc | Contact | 1-888-463-1835 | 18439 | labomorin@usherbrooke.ca |
| Kathryne Brûlé, MSc | Contact | 1-819-821-8000 | 18439 | labomorin@usherbrooke.ca |
| Name | Affiliation | Role |
|---|---|---|
| Mélanie Morin | Université de Sherbrooke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier universitaire de Québec - Université Laval | Not yet recruiting | Québec | Quebec | G1V 4G2 | Canada |
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| Label | URL |
|---|---|
| Research lab's official website | View source |
| Research lab's official Facebook page | View source |
| Research lab's official Instagram page |
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Deidentified data could be made available upon approval by the principal investigator and study team.
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| ID | Term |
|---|---|
| D056650 | Vulvodynia |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| UNKNOWN |
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Participants, assessors, investigators and analysts will be blinded to group allocation.
| Sham dry needling | Other | The same treatment regimen will be applied using sham, non-penetrating, needles. |
|
To assess 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-month follow-up assessment |
| Change in sexual distress | To assess 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-month follow-up assessment |
| Change in pain catastrophizing | To assess 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-month follow-up assessment |
| Change in fear of pain | To assess 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-month follow-up assessment |
| Change in cognitions regarding vaginal penetration | To assess the cognitions of women toward vaginal penetration (Vaginal penetration cognition questionnaire - VPCQ). Minimum value: 0, Maximum value: 12 to 36. | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment |
| Change in quality of life interference | To assess the change in the impact on the quality of life (Life Interference subscale of the Vulvar Pain Assessment Questionnaire - VPAQ). Minimum value: 0, Maximum value: 4, higher scores indicate that the vulvar pain of the participants has a strong impact on their life. | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment |
| Changes in intercourse self-efficacy | To assess the changes in self-efficacy regarding painful intercourse (Painful Intercourse Self-Efficacy Scale). Minimum value: 10, Maximum value: 100, higher scores indicate higher self-efficacy. | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment |
| Change in pelvic floor muscle function | To assess changes in pelvic floor muscle function (dynamometric speculum). | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment |
| Change in pelvic floor morphometry | To assess changes in pelvic floor morphometry (transperineal 3D-4D ultrasound). | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment |
| Level of satisfaction with treatment | To determine 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-month follow-up assessment |
| Patient's global impression of change | To examine patient self-reported change (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-month follow-up assessment |
| Patient's perception of improvement | To examine patient's estimated percent of improvement on a Numerical Rating Scale (NRS) ranging from 0% (no improvement) to 100% (complete improvement). | 2-week post-treatment evaluation, 6-month follow-up assessment |
| Kinatex l'Ormière | Not yet recruiting | Québec | Quebec | G2B 3K3 | Canada |
|
| Centre hospitalier universitaire de Sherbrooke | Recruiting | Sherbrooke | Quebec | J1H 5N4 | Canada |
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| Cigonia | Recruiting | Sherbrooke | Quebec | J1L 1C6 | Canada |
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| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |