Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (12)

• Change in pain quality [Срок оценки: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment]
• Change in sexual function [Срок оценки: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment]
• Change in sexual distress [Срок оценки: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment]
• Change in pain catastrophizing [Срок оценки: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment]
• Change in fear of pain [Срок оценки: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment]
• Change in cognitions regarding vaginal penetration [Срок оценки: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment]
• Change in quality of life interference [Срок оценки: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment]
• Changes in intercourse self-efficacy [Срок оценки: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment]
• Change in pelvic floor muscle function [Срок оценки: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment]
• Change in pelvic floor morphometry [Срок оценки: Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment]
• Level of satisfaction with treatment [Срок оценки: 2-week post-treatment evaluation, 6-month follow-up assessment]
• Patient's global impression of change [Срок оценки: 2-week post-treatment evaluation, 6-month follow-up assessment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Канада · 4 центра

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

Идентификаторы

NCT: NCT07534345 · MP-31-2026-6081

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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