Multimodal Rehabilitation Programme on Epigenetic Biomarkers, Quality of Life, Sexual Function and Muscle Strength in Women With Dyspareunia and Endometriosis.
- Conditions
- Multidisciplinary Communication
- Interventions
- Other: Multimodal Rehabilitation
- Registration Number
- NCT06614465
- Lead Sponsor
- Clínica INEBIR
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 126
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1.Experimental Group Multimodal Rehabilitation The intervention group will receive a multimodal rehabilitation programme including therapeutic exercise, health education and manual therapy.
- Primary Outcome Measures
Name Time Method miR-21 1 month miR-21 levels in saliva
Quality of life 1 month will be measured with the The Short Form-36 Health Survey (SF-36). A higher score indicates better health status.
Sexual Function 1 month Will be measured with the Female Sexual Function Index (FSFI) questionnaire. A higher score indicates better sexual function.
Pelvic Floor Muscle Strength 1 month Will be measured with Oxford and Perfect scale. A higher score indicates better Muscle Strength status.
Pain 1 month Will be measured with Brief Pain Inventory (BPI) Questionnaire. A higher score indicates worse health status.
- Secondary Outcome Measures
Name Time Method Systemic inflammation 1 month Will be measured with polymerase chain reaction (PCR).
Hormone Levels 1 month Will be measured with blood test.
Psychological condition 1 month Will be measured with Hospital Anxiety and Depression Scale (HADS). A higher score indicates worse health status.
satisfaction with the intervention 1 month Will be measured with MedRisk questionnaire. The MedRisk Instrument for Measuring Patient Satisfaction With Physical Therapy Care. A higher score indicates greater disability or more pain.
Trial Locations
- Locations (1)
Universidad Pablo de Olavide
🇪🇸Sevilla, Andalucía, Spain