Effect of a Multimodal Rehabilitation Programme on Epigenetic Biomarkers, Quality of Life, Sexual Function and Muscle Strength in Women With Dyspareunia and Endometriosis: Protocol for a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- miR-21
研究概览
简要总结
This study aims to evaluate the impact of a multimodal rehabilitation programme on epigenetic biomarkers in blood, quality of life, sexual function and pelvic floor muscle strength and endurance in women with dyspareunia and endometriosis.
详细描述
Introduction: Endometriosis is a benign gynaecological disease that affects approximately 10% of women of childbearing age, causing chronic pelvic pain and profound dyspareunia, which significantly impairs quality of life. This study aims to evaluate the impact of a multimodal rehabilitation programme on epigenetic biomarkers, quality of life, sexual function and muscle strength in women with dyspareunia and endometriosis.
Study Design: Pilot of Randomised controlled clinical trial according to CONSORT and TIDieR guidelines. The study will run from January 2025 to January 2026.
Inclusion criteria: Women between 18 and 55 years old, diagnosed with endometriosis with dyspareunia and chronic pelvic pain, with the ability to communicate in Spanish, and approval of their gynaecologist.
Exclusion criteria: Neurological, oncological, autoimmune or serious psychiatric diseases that prevent exercise or manual therapy.
Sample Size: 20 women diagnosed with dyspareunia and endometriosis, randomly divided into two groups: 10 in the intervention group and 10 in the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with endometriosis
- •Women with dyspareunia and chronic pelvic pain
- •Ability to communicate fluently verbally and in writing in the language of the research team, in this case Spanish.
- •Approval to participate in the study by your regular gynaecologist who is part of your diagnosis and treatment.
排除标准
- •A neurological, oncological or autoimmune disease that prevents the participant from performing exercise.
- •Any type of pathology that prevents the participant from performing exercise.
- •A diagnosis of severe psychiatric or neurological disorders that do not allow the participant to follow orders.
结局指标
主要结局
miR-21
时间窗: 1 month
miR-21 levels in saliva
Quality of life
时间窗: 1 month
will be measured with the The Short Form-36 Health Survey (SF-36). A higher score indicates better health status.
Sexual Function
时间窗: 1 month
Will be measured with the Female Sexual Function Index (FSFI) questionnaire. A higher score indicates better sexual function.
Pelvic Floor Muscle Strength
时间窗: 1 month
Will be measured with Oxford and Perfect scale. A higher score indicates better Muscle Strength status.
Pain
时间窗: 1 month
Will be measured with Brief Pain Inventory (BPI) Questionnaire. A higher score indicates worse health status.
次要结局
- Systemic inflammation(1 month)
- Hormone Levels(1 month)
- Psychological condition(1 month)
- satisfaction with the intervention(1 month)