Dry needling to reduce pain during intercourse for provoked vestibulodynia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre hospitalier universitaire de Sherbrooke
  Sherbrooke, Quebec, Canada Recruiting
• Cigonia
  Sherbrooke, Quebec, Canada Recruiting
• Centre hospitalier universitaire de Québec - Université Laval
  Québec, Quebec, Canada Not yet recruiting
• Kinatex l'Ormière
  Québec, Quebec, Canada Not yet recruiting

Study contacts

• Principal investigator: Mélanie Morin — Université de Sherbrooke
• Study coordinator: Camille Simard, MSc
• Email: labomorin@usherbrooke.ca
• Phone: 1-888-463-1835

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• IncobotulinumtoxinA (botulinum toxin) injections for provoked vestibulodynia with overactive pelvic floor muscles

  This trial will test whether injections of incobotulinumtoxinA reduce pain during standardized dilator testing in premenopausal women with provoked vestibulodynia and hypertonic pelvic floor muscles.

  Recruiting at 2 sites Phase 2 Center for Vulvovaginal Disorders · Washington D.C., District of Columbia and 1 other locations · NCT07486830

• Topical ketotifen 0.25% for secondary vestibulodynia

  This Phase 2 trial will test whether applying ketotifen 0.25% cream to the vulvar vestibule reduces pain in adult women with secondary provoked vestibulodynia.

  Recruiting at 3 sites Phase 2 Center for Vulvovaginal Disorders · Washington D.C., District of Columbia and 2 other locations · NCT07257029

• 12-week online pelvic health program for provoked vestibulodynia

  This project will try a 12-week online pelvic health program to see if it reduces pain and improves sexual wellbeing for adults in North America with provoked vestibulodynia.

  Recruiting Queen's University · Kingston, Ontario · NCT06999395

• Interventions for managing pelvic health issues in women

  This study is testing whether light therapy and physical therapy can help women with vulvar pain feel better over 14 weeks.

  Recruiting at 2 sites University of Ottawa · Ottawa, Ontario and 1 other locations · NCT06660212

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.