Provoked VestibulodyniaNCT07534345
Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse
A study testing Real dry needling in people with Provoked Vestibulodynia, run by Université de Sherbrooke at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Provoked Vestibulodynia
- What is being tested?
- Real dry needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 4 sitesCanada
- Study dates
- 11 May 2026to Jun 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Not yet recruiting
Centre hospitalier universitaire de Québec - Université Laval
Québec, Quebec, G1V 4G2
Camille Simard, 1-888-463-1835 ext. 18439, labomorin@usherbrooke.ca
Kathryne Brûlé, 1-819-821-8000 ext. 18439, labomorin@usherbrooke.ca
- Not yet recruiting
Kinatex l'Ormière
Québec, Quebec, G2B 3K3
Camille Simard, MSc, 1-888-463-1835 ext. 18439, labomorin@usherbrooke.ca
Kathryne Brûlé, MSc, 1-819-821-8000 ext. 18439, labomorin@usherbrooke.ca
- Recruiting
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Camille Simard, MSc, 1-888-463-1835 ext. 18439, labomorin@usherbrooke.ca
Kathryne Brûlé, MSc, 1-819-821-8000 ext. 18439, labomorin@usherbrooke.ca
- Recruiting
Cigonia
Sherbrooke, Quebec, J1L 1C6
Camille Simard, MSc, 1-888-463-1835 ext. 18439, labomorin@usherbrooke.ca
Kathryne Brûlé, MSc, 1-819-821-8000 ext. 18439, labomorin@usherbrooke.ca
About this study
Official title: Efficacy of Dry Needling for Reducing Pain During Intercourse in Women With Provoked Vestibulodynia: A Multicenter Randomized Controlled Trial
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.
- Conditions
- Provoked Vestibulodynia
- Being tested
- Real dry needling, Sham dry needling
- Keywords
- Sexual dysfunctions, Chronic vulvar pain, Dry needling, Vulvodynia, Superficial dyspareunia, Randomized controlled trial
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real dry needlingOther
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.
Sham dry needlingOther
The same treatment regimen will be applied using sham, non-penetrating, needles.
| Study group | Role | What they receive |
|---|---|---|
| Real dry needling | Experimental | Real dry needling, i.e., penetrating needles, for 8 consecutive weekly sessions. Receives: Other: Real dry needling |
| Sham dry needling | Sham comparator | Sham dry needling, i.e., non-penetrating needles, for 8 consecutive weekly sessions. Receives: Other: Sham dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
Secondary outcomes (13)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 2-week post-treatment evaluation, 6-month follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start11 May 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Provoked VestibulodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Cigonia, CHU de Quebec-Universite Laval, Kinatex l'Ormière
- Responsible party
- Principal investigator, Mélanie Morin, Université de Sherbrooke
- Investigators
- Mélanie Morin, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534345
- Sponsor's protocol ID
- MP-31-2026-6081
- Status last verified
- May 2026
- First submitted
- 9 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified data could be made available upon approval by the principal investigator and study team.