Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse

May 11, 2026 updated by: Mélanie Morin, Université de Sherbrooke

Efficacy of Dry Needling for Reducing Pain During Intercourse in Women With Provoked Vestibulodynia: A Multicenter Randomized Controlled Trial

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 4G2
        • Not yet recruiting
        • Centre hospitalier universitaire de Québec - Université Laval
        • Contact:
        • Contact:
        • Principal Investigator:
          • Annie-Kim Gareau-Labelle, MD
      • Québec, Quebec, Canada, G2B 3K3
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Centre Hospitalier Universitaire de Sherbrooke
        • Principal Investigator:
          • Mélanie Morin, PhD
        • Contact:
        • Contact:
      • Sherbrooke, Quebec, Canada, J1L 1C6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real dry needling
Real dry needling, i.e., penetrating needles, for 8 consecutive weekly sessions.
Other: 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 Comparator: Sham dry needling
Sham dry needling, i.e., non-penetrating needles, for 8 consecutive weekly sessions.
Other: Sham dry needling
The same treatment regimen will be applied using sham, non-penetrating, needles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity during intercourse
Time Frame: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain quality
Time Frame: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
To assess changes in the sensory, affective, and evaluative components of pain (McGill-Melzack Questionnaire). Minimum value: 0, Maximum value: 77, higher scores indicate a worse outcome (higher pain).
Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
Change in sexual function
Time Frame: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
To assess changes in sexual function (Female Sexual Function Index - FSFI). Minimum value: 2, Maximum value: 36, lower scores indicate a worse outcome (low sexual function).
Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
Change in sexual distress
Time Frame: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
To assess changes in sexual distress (Female Sexual Distress Scale - FSDS). Minimum value: 0, Maximum value: 52, higher scores indicate a worse outcome (higher sexually-related distress).
Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
Change in pain catastrophizing
Time Frame: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
To assess changes in pain catastrophizing (Pain Catastrophizing Scale - PCS). Minimum value: 0, Maximum value: 52, higher scores indicate a worse outcome (higher pain catastrophizing).
Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
Change in fear of pain
Time Frame: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
To assess changes in fear of pain (Pain Anxiety Symptoms Scale - PASS-20). Minimum value: 0, Maximum value: 100, higher scores indicate a worse outcome (higher fear of pain).
Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
Change in cognitions regarding vaginal penetration
Time Frame: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
To assess the cognitions of women toward vaginal penetration (Vaginal penetration cognition questionnaire - VPCQ). Minimum value: 0, Maximum value: 12 to 36.
Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
Change in quality of life interference
Time Frame: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
To assess the change in the impact on the quality of life (Life Interference subscale of the Vulvar Pain Assessment Questionnaire - VPAQ). Minimum value: 0, Maximum value: 4, higher scores indicate that the vulvar pain of the participants has a strong impact on their life.
Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
Changes in intercourse self-efficacy
Time Frame: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
To assess the changes in self-efficacy regarding painful intercourse (Painful Intercourse Self-Efficacy Scale). Minimum value: 10, Maximum value: 100, higher scores indicate higher self-efficacy.
Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
Change in pelvic floor muscle function
Time Frame: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
To assess changes in pelvic floor muscle function (dynamometric speculum).
Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
Change in pelvic floor morphometry
Time Frame: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
To assess changes in pelvic floor morphometry (transperineal 3D-4D ultrasound).
Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment
Level of satisfaction with treatment
Time Frame: 2-week post-treatment evaluation, 6-month follow-up assessment
To determine the participants' satisfaction with the treatment on a Numeric Rating Scale (NRS) ranging from 0 (completely dissatisfied) to 10 (completely satisfied).
2-week post-treatment evaluation, 6-month follow-up assessment
Patient's global impression of change
Time Frame: 2-week post-treatment evaluation, 6-month follow-up assessment
To examine patient self-reported change (Patient's Global Impression of Change - PGIC) ranging from "very much worse" to "very much improved" on a 7-point scale.
2-week post-treatment evaluation, 6-month follow-up assessment
Patient's perception of improvement
Time Frame: 2-week post-treatment evaluation, 6-month follow-up assessment
To examine patient's estimated percent of improvement on a Numerical Rating Scale (NRS) ranging from 0% (no improvement) to 100% (complete improvement).
2-week post-treatment evaluation, 6-month follow-up assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

CHU de Quebec-Universite Laval
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Kinatex l'Ormière
Cigonia

Investigators

  • Principal Investigator: Mélanie Morin, Université de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-31-2026-6081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Deidentified data could be made available upon approval by the principal investigator and study team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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