An interventional study of Real dry needling and Sham dry needling in Provoked Vestibulodynia, sponsored by Université de Sherbrooke. Recruiting at 4 sites in Canada. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Treatment
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.
117 studies on the registry are indexed under Vulvodynia; 21 are open to participants now.
This study's planned enrollment of 170 is above the median of 46 across 89 interventional studies indexed under Vulvodynia.
Browse Vulvodynia studies →Université de Sherbrooke is the lead sponsor of 295 studies on the registry; 65 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Real dry needling, i.e., penetrating needles, for 8 consecutive weekly sessions.
Other: Real dry needling
Sham dry needling, i.e., non-penetrating needles, for 8 consecutive weekly sessions.
Other: Sham 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.
The same treatment regimen will be applied using sham, non-penetrating, needles.
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).
Time frame: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
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).
Time frame: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
Change in sexual function
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 2-week post-treatment evaluation, 6-month follow-up assessment
Plan to share: Undecided — Deidentified data could be made available upon approval by the principal investigator and study team.
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