Graded Motor Imagery in Women Diagnosed With Genito-Pelvic Pain Penetration Disorder. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Sexual function
研究概览
简要总结
The goal of this clinical trial is to assess the effects of a Graded Motor Imagery (GMI) programme in women diagnosed with Genito-Pelvic Pain Penetration (GPPD) Disorder.
The main questions it aims to answer are:
Does a GMI programme reduce pain intensity levels in women diagnosed with GPPPD? Does a GMI programme have an effect on sexual function in women diagnosed with GPPPD?
Participants will undergo a GMI programme and will be tested prior to and after the intervention to assess if the programme has a significant effect with regards to pain intensity and other pain-related outcome
详细描述
Graded Motor Imagery has been extensively used in several populations suffering pain-related disorders. It triggers cortical stimulation gradually in order to have an effect on the alterations that might have occured due to pain
Women suffering from Genito-Pelvic Pain Penetration Disorder deal with persistent pelvic pain that is no longer responding to a noxious stimulus, therefore this clinical presentation could have several cortical alterations implicated.
The main goal of this study is to assess if a Graded Motor Imagery programme is able to reduce pain intensity and improve sexual function in women diagnosed with Genito-Pelvic Pain Penetration Disorder.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with persistent pelvic pain
- •Pain suffered for a period of a minimum of 3 months
- •Adult (>18 years) women
排除标准
- •Medical condition that logically explains the presence of pain
- •Pain suffered for a period of less than 3 months
结局指标
主要结局
Sexual function
时间窗: 6 weeks
Sexual function assessed through a short version of the Female Sexual Function Index (FSFI). Minimum score is 6, maximum score is 30. Higher scores mean better outcome.
Pain Intensity
时间窗: 6 weeks
Pain intensity assessed through a Visual Analogue Scale, with a mininum value of 0 and a maximum value of 10, higher scores mean a worse outcome
次要结局
未报告次要终点
研究者
Borja Pérez-Domínguez
Assistant Professor
University of Valencia