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

Clínica INEBIR

Status

Active, not recruiting

Conditions

Multidisciplinary Communication

Treatments

Other: Multimodal Rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT06614465

Endometriosis and dyspareunia

Details and patient eligibility

About

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.

Full 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).

Enrollment

126 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.