Dry needling to reduce pain during intercourse for provoked vestibulodynia
Efficacy of Dry Needling for Reducing Pain During Intercourse in Women With Provoked Vestibulodynia: A Multicenter Randomized Controlled Trial
This trial will test whether dry needling can reduce pain during intercourse in women with provoked vestibulodynia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Université de Sherbrooke Academic / other |
| Locations | 4 sites (Québec, Quebec and 3 other locations) |
| Trial ID | NCT07534345 on ClinicalTrials.gov |
What this trial studies
This randomized pilot compares real dry needling to a sham procedure using a standardized protocol targeting pelvic and vestibular muscles implicated in provoked vestibulodynia. Eligible participants are premenopausal women with at least 3 months of vulvo-vaginal pain during intercourse and an average pain score of ≥5/10, confirmed by a gynecologic exam. The trial measures changes in intercourse-related pain using validated pain scales and examines feasibility and acceptability of the treatment protocol. Previous pilot work by the team established the protocol's feasibility and informed the randomized design.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women with confirmed provoked vestibulodynia causing intercourse pain for more than 3 months with an average pain of at least 5/10 and who have not previously received dry needling or acupuncture.
Not a fit: Patients with other vulvar or pelvic pain diagnoses (unprovoked pain, deep dyspareunia, dermatologic conditions), postmenopausal status, prior pelvic surgery, current pregnancy, recent medication changes affecting pain, or major comorbidities are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could reduce intercourse-related pain and improve sexual function and quality of life for some women with PVD.
How similar studies have performed: Preliminary pilot data from this team showed the protocol is feasible and acceptable, and other interventions targeting pelvic muscle dysfunction have shown mixed but promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Québec, Quebec and 3 other locations
- Centre hospitalier universitaire de Québec - Université Laval — Québec, Quebec, Canada (Not_yet_recruiting)
- Kinatex l'Ormière — Québec, Quebec, Canada (Not_yet_recruiting)
- Centre hospitalier universitaire de Sherbrooke — Sherbrooke, Quebec, Canada (Recruiting)
- Cigonia — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Mélanie Morin — Université de Sherbrooke
- Study coordinator: Camille Simard, MSc
- Email: labomorin@usherbrooke.ca
- Phone: 1-888-463-1835
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.