NCT07534345

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Provoked Vestibulodynia

Keywords

Sexual dysfunctionsChronic vulvar painDry needlingVulvodyniaSuperficial dyspareuniaRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment

Secondary Outcomes (13)

  • Change in pain quality

    Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment

  • Change in sexual function

    Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment

  • Change in sexual distress

    Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment

  • Change in pain catastrophizing

    Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment

  • Change in fear of pain

    Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment

  • +8 more secondary outcomes

Study Arms (2)

Real dry needling

EXPERIMENTAL

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

Other: Real dry needling

Sham dry needling

SHAM COMPARATOR

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

Other: Sham dry needling

Interventions

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.

Real dry needling
Sham dry needlingOTHER

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

Sham dry needling

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre hospitalier universitaire de Québec - Université Laval

Québec, Quebec, G1V 4G2, Canada

Location

Kinatex l'Ormière

Québec, Quebec, G2B 3K3, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Cigonia

Sherbrooke, Quebec, J1L 1C6, Canada

Location

Related Links

MeSH Terms

Conditions

Vulvodynia

Condition Hierarchy (Ancestors)

Vulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Mélanie Morin

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Camille Simard, MSc

CONTACT

1-888-463-1835labomorin@usherbrooke.ca

Kathryne Brûlé, MSc

CONTACT

1-819-821-8000labomorin@usherbrooke.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants, assessors, investigators and analysts will be blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: * 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, Professor, and Researcher

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

CA(4)