Multimodal Rehabilitation Programme on Epigenetic Biomarkers, Quality of Life, Sexual Function and Muscle Strength in Women With Dyspareunia and Endometriosis.

Overview

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.

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).

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