Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse
RecruitingNot applicableNCT07534345
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Brief summary (from the registry)
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.
Study details
- Official title
- Efficacy of Dry Needling for Reducing Pain During Intercourse in Women With Provoked Vestibulodynia: A Multicenter Randomized Controlled Trial
- Conditions
- Provoked Vestibulodynia
- Interventions
- Other: Real dry needling
- Other: Sham dry needling
- Sponsor
- Université de Sherbrooke
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke; Cigonia; CHU de Quebec-Universite Laval; Kinatex l'Ormière
- Start date
- 2026-05-11
- Primary completion
- 2029-06
- Sex
- Female
- Age range
- from 18 Years to 45 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Canadian sites (4)
| Facility | City | Province |
|---|---|---|
| Centre hospitalier universitaire de Québec - Université Laval | Québec | Quebec |
| Kinatex l'Ormière | Québec | Quebec |
| Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec |
| Cigonia | Sherbrooke | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07534345