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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.Experimental Group | Experimental | The intervention group will receive a multimodal rehabilitation programme including therapeutic exercise, health education and manual therapy. |
|
| 2.Control Group | No Intervention | The control group will not receive this intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic inflammation | Will be measured with polymerase chain reaction (PCR). | 1 month |
| Hormone Levels | Will be measured with blood test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Pablo de Olavide | Seville | Andalusia | 41013 | Spain |
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| 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 |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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