Clinical trial NCT06614465: Multimodal Rehabilitation Programme on Epigenetic Biomarkers, Quality of Life, Sexual Function and Muscle Strength in Women With Dyspareunia and Endometriosis.
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multidisciplinary Communication
Keywords: Endometriosis
Dyspareunia
Multimodal Rehabilitation
Epigenetic Biomarkers
Quality of life
Sexual Function
Muscle Strength
Lead sponsor: Clínica INEBIR
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: miR-21
timeFrame: 1 month
measure: Quality of life
timeFrame: 1 month
measure: Sexual Function
timeFrame: 1 month
measure: Pelvic Floor Muscle Strength
timeFrame: 1 month
measure: Pain
timeFrame: 1 month
Secondary outcomes:
measure: Systemic inflammation
timeFrame: 1 month
measure: Hormone Levels
timeFrame: 1 month
measure: Psychological condition
timeFrame: 1 month
measure: satisfaction with the intervention
timeFrame: 1 month
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Universidad Pablo de Olavide
state: Andalucía
Study officials:
References: