Efficacy of Dry Needling for Reducing Pain During Intercourse in Women With Provoked Vestibulodynia: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 4
- 主要终点
- Change in pain intensity during intercourse
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, assessors, investigators and analysts will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Real dry needling
Real dry needling, i.e., penetrating needles, for 8 consecutive weekly sessions.
干预措施: Real dry needling (Other)
Sham dry needling
Sham dry needling, i.e., non-penetrating needles, for 8 consecutive weekly sessions.
干预措施: Sham dry needling (Other)
结局指标
主要结局
Change in pain intensity during intercourse
时间窗: 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).
次要结局
- 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)
- Change in cognitions regarding vaginal penetration(Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment)
- Change in quality of life interference(Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment)
- Changes in intercourse self-efficacy(Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment)
- Change in pelvic floor muscle function(Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment)
- Change in pelvic floor morphometry(Baseline, 2-week post-treatment evaluation, 6-month follow-up assessment)
- Level of satisfaction with treatment(2-week post-treatment evaluation, 6-month follow-up assessment)
- Patient's global impression of change(2-week post-treatment evaluation, 6-month follow-up assessment)
- Patient's perception of improvement(2-week post-treatment evaluation, 6-month follow-up assessment)
研究者
Mélanie Morin
Physiotherapist, Professor, and Researcher
Université de Sherbrooke