Recruiting

Dry Needling

Sponsor:

Université de Sherbrooke

Code:

NCT07534345

Conditions

Provoked Vestibulodynia

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Real dry needling

Sham dry needling

Study Details

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.

Conditions

Provoked Vestibulodynia

Study ID

NCT07534345

Start date

May 11, 2026

Status verified date

May, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Real dry needling

Real dry needling, i.e., penetrating needles, for 8 consecutive weekly sessions.

sham comparator: Sham dry needling

Sham dry needling, i.e., non-penetrating needles, for 8 consecutive weekly sessions.

Interventions

Real 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.

Sham dry needling

The same treatment regimen will be applied using sham, non-penetrating, needles.

Primary outcome measure

  • Change in pain intensity during intercourse [ Time Frame: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment ]

Central Contacts and Locations

Central contacts

Locations

Centre hospitalier universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Principal Investigator:

Mélanie Morin, PhD

Cigonia

Recruiting

Sherbrooke, Quebec, Canada, J1L 1C6

Contacts

More Information

Sponsor

Université de Sherbrooke

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

  • Sexual dysfunctions
  • Chronic vulvar pain
  • Dry needling
  • Vulvodynia
  • Superficial dyspareunia
  • Randomized controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2026-05-12.