INEBIR Clinic
This study aims to evaluate the impact of a multimodal rehabilitation programme on epigenetic biomarkers in saliva (especially miR-21), quality of life, sexual function and pelvic floor muscle strength and endurance in women with dyspareunia and endometriosis.
Multidisciplinary Communication
Multimodal Rehabilitation
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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 (particularly miR-21), quality of life, sexual function and muscle strength in women with dyspareunia and endometriosis. Study Design: 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 50 years old, diagnosed with endometriosis with dyspareunia and chronic pelvic pain, under hormonal treatment, 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: 126 women diagnosed with dyspareunia and endometriosis, randomly divided into two groups: 63 in the intervention group and 63 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), 3 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 Seville (CEIUS), 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).
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 126 participants |
| Masking : | NONE |
| Primary Purpose : | SUPPORTIVE_CARE |
| Official Title : | 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. |
| Actual Study Start Date : | 2025-01-08 |
| Estimated Primary Completion Date : | 2026-01-31 |
| Estimated Study Completion Date : | 2027-01-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 50 Years |
| Sexes Eligible for Study: | FEMALE |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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