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NCT Number: NCT07534345

Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse

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.

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Key information

Conditions

Provoked Vestibulodynia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vulvar Diseases Vulvodynia

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier universitaire de Québec - Université Laval, Québec, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Real dry needling

Other

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

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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).

  11. 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).

  12. 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.

  13. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Camille Simard, MSc

CONTACT

[email protected]

1-888-463-1835 ext. 18439

Kathryne Brûlé, MSc

CONTACT

[email protected]

1-819-821-8000 ext. 18439

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 16, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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