Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse

Official title

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

Overview

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.

Interventions

• 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.
• Other Sham dry needling
  The same treatment regimen will be applied using sham, non-penetrating, needles.

Primary outcome measures

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

Secondary outcome measures (12)

• Change in pain quality [Time frame: 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]
• Change in sexual distress [Time frame: 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]
• Change in fear of pain [Time frame: 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]
• Change in quality of life interference [Time frame: 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]
• Change in pelvic floor muscle function [Time frame: 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]
• Level of satisfaction with treatment [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Canada · 4 centers

• Centre hospitalier universitaire de Québec - Université Laval — Québec
• Kinatex l'Ormière — Québec
• Centre hospitalier universitaire de Sherbrooke — Sherbrooke
• Cigonia — Sherbrooke

Identifiers

NCT: NCT07534345 · MP-31-2026-6081

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗