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

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multidisciplinary Communication
• Intervention / Treatment: Other: Multimodal Rehabilitation

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).

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Andalucía
    • Sevilla, Andalucía, Spain, 41013
      • Universidad Pablo de Olavide

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1.Experimental Group; The intervention group will receive a multimodal rehabilitation programme including therapeutic exercise, health education and manual therapy.	Other: Multimodal Rehabilitation; The intervention will consist of 4 sessions of education in pain neuroscience, 4 sessions of therapeutic exercise and 4 sessions of manual therapy in the abdominopelvic area.
No Intervention: 2.Control Group; The control group will not receive this intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
miR-21	miR-21 levels in saliva	1 month
Quality of life	will be measured with the The Short Form-36 Health Survey (SF-36). A higher score indicates better health status.	1 month
Sexual Function	Will be measured with the Female Sexual Function Index (FSFI) questionnaire. A higher score indicates better sexual function.	1 month
Pelvic Floor Muscle Strength	Will be measured with Oxford and Perfect scale. A higher score indicates better Muscle Strength status.	1 month
Pain	Will be measured with Brief Pain Inventory (BPI) Questionnaire. A higher score indicates worse health status.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic inflammation	Will be measured with polymerase chain reaction (PCR).	1 month
Hormone Levels	Will be measured with blood test.	1 month
Psychological condition	Will be measured with Hospital Anxiety and Depression Scale (HADS). A higher score indicates worse health status.	1 month
satisfaction with the intervention	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.	1 month

Collaborators and Investigators

• Sponsor: Clínica INEBIR

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Endometriosis; Muscle Strength; Dyspareunia; Sexual Function; Epigenetic Biomarkers; Multimodal Rehabilitation
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Endometriosis; Dyspareunia
• Other Study ID Numbers: Endometriosis and dyspareunia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No