Provoked Vestibulodynia
Conditions
Keywords
Sexual dysfunctions, Chronic vulvar pain, Dry needling, Vulvodynia, Superficial dyspareunia, Randomized controlled trial
Brief summary
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.
Interventions
OTHERReal dry needling
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.
OTHERSham dry needling
The same treatment regimen will be applied using sham, non-penetrating, needles.
Sponsors
Université de Sherbrooke
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Cigonia
CHU de Quebec-Universite Laval
Kinatex l'Ormière
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants, assessors, investigators and analysts will be blinded to group allocation.
Intervention model description
* Baseline evaluation * Randomization to real or sham dry needling (8 sessions over 8 consecutive weeks) * Post-treatment evaluation (2-week post-treatment) * Follow-up evaluation (6-month post-treatment)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women reporting vulvo-vaginal pain during intercourse for \>3 months with an average pain intensity of ≥5/10 on a numerical rating scale (NRS); * Confirmed diagnosis of provoked vestibulodynia by a gynecologist of our team following a standardized gynaecologic exam.
Exclusion criteria
* Other urogynecological and vulvar pain conditions (e.g., unprovoked pain, deep dyspareunia, dermatological condition); * Prior vulvovaginal or pelvic surgery; * Current pregnancy; * Postmenopausal status; * Having previously received DN or acupuncture; * Expected changes of medication that could influence pain perception (e.g., antidepressant); * Any significant coexisting medical conditions likely to interfere with the study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity during intercourse | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain quality | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment | 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). |
| Change in sexual function | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment | 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). |
| Change in sexual distress | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment | 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). |
| Change in pain catastrophizing | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment | 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). |
| Change in fear of pain | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment | 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). |
| Change in cognitions regarding vaginal penetration | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment | To assess the cognitions of women toward vaginal penetration (Vaginal penetration cognition questionnaire - VPCQ). Minimum value: 0, Maximum value: 12 to 36. |
| Change in quality of life interference | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment | 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. |
| Changes in intercourse self-efficacy | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment | 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. |
| Change in pelvic floor muscle function | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment | To assess changes in pelvic floor muscle function (dynamometric speculum). |
| Change in pelvic floor morphometry | Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment | To assess changes in pelvic floor morphometry (transperineal 3D-4D ultrasound). |
| Level of satisfaction with treatment | 2-week post-treatment evaluation, 6-month follow-up assessment | To determine the participants' satisfaction with the treatment on a Numeric Rating Scale (NRS) ranging from 0 (completely dissatisfied) to 10 (completely satisfied). |
| Patient's global impression of change | 2-week post-treatment evaluation, 6-month follow-up assessment | 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. |
| Patient's perception of improvement | 2-week post-treatment evaluation, 6-month follow-up assessment | To examine patient's estimated percent of improvement on a Numerical Rating Scale (NRS) ranging from 0% (no improvement) to 100% (complete improvement). |
Countries
Canada
Contacts
CONTACTCamille Simard, MSc
CONTACTKathryne Brûlé, MSc
PRINCIPAL_INVESTIGATORMélanie Morin
Université de Sherbrooke
Outcome results
None listed