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NCT Number: NCT06614465

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal Rehabilitation

Other

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.

Primary outcomes

  1. miR-21

    Time frame: 1 month

    miR-21 levels in saliva

  2. Quality of life

    Time frame: 1 month

    will be measured with the The Short Form-36 Health Survey (SF-36). A higher score indicates better health status.

  3. Sexual Function

    Time frame: 1 month

    Will be measured with the Female Sexual Function Index (FSFI) questionnaire. A higher score indicates better sexual function.

  4. Pelvic Floor Muscle Strength

    Time frame: 1 month

    Will be measured with Oxford and Perfect scale. A higher score indicates better Muscle Strength status.

  5. Pain

    Time frame: 1 month

    Will be measured with Brief Pain Inventory (BPI) Questionnaire. A higher score indicates worse health status.

Secondary outcomes

  1. Systemic inflammation

    Time frame: 1 month

    Will be measured with polymerase chain reaction (PCR).

  2. Hormone Levels

    Time frame: 1 month

    Will be measured with blood test.

  3. Psychological condition

    Time frame: 1 month

    Will be measured with Hospital Anxiety and Depression Scale (HADS). A higher score indicates worse health status.

  4. satisfaction with the intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Clínica INEBIR

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 26, 2024
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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