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.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Multidisciplinary Communication
- Sponsor
- Clínica INEBIR
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- miR-21
- Status
- Active, Not Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Detailed Description
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. Intervention: The intervention group will receive a multimodal rehabilitation programme including therapeutic exercise, health education and manual therapy. The control group will not receive this intervention. Primary results: Measurements will be taken at four key points in time: baseline (T0), 2 months (T1), 6 months (T2) and 12 months (T3). To assess the effect of the intervention on miR-21 levels in saliva, quality of life (SF-36 questionnaire), sexual function (FSFI), pain, and pelvic floor muscle strength (measured with Oxford and Perfect scales). Second Results: Measurement of systemic inflammation by CRP and IL-6, hormone levels (oestrogen and progesterone), stress and psychological well-being (HADS), muscle strength (EPI-NO), adherence to treatment and satisfaction with the intervention. Ethics and Privacy: The study will have the approval of the Ethics Committee of the University of Pablo de Olavide, following the Declaration of Helsinki and Spanish regulations (Law 14/2007 on Biomedical Research). Participants will sign an informed consent form, and the data will be managed in accordance with the Spanish Data Protection Act (Law 3/2018).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
miR-21
Time Frame: 1 month
miR-21 levels in saliva
Quality of life
Time Frame: 1 month
will be measured with the The Short Form-36 Health Survey (SF-36). A higher score indicates better health status.
Sexual Function
Time Frame: 1 month
Will be measured with the Female Sexual Function Index (FSFI) questionnaire. A higher score indicates better sexual function.
Pelvic Floor Muscle Strength
Time Frame: 1 month
Will be measured with Oxford and Perfect scale. A higher score indicates better Muscle Strength status.
Pain
Time Frame: 1 month
Will be measured with Brief Pain Inventory (BPI) Questionnaire. A higher score indicates worse health status.
Secondary Outcomes
- Systemic inflammation(1 month)
- Hormone Levels(1 month)
- Psychological condition(1 month)
- satisfaction with the intervention(1 month)