Multimodal Rehabilitation Programme on Epigenetic Biomarkers, Quality of Life, Sexual Function and Muscle Strength in Women With Dyspareunia and Endometriosis.
NCT ID: NCT06614465
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
126 participants
INTERVENTIONAL
2025-01-08
2027-01-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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1.Experimental Group
The intervention group will receive a multimodal rehabilitation programme including therapeutic exercise, health education and manual therapy.
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.
2.Control Group
The control group will not receive this intervention.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
FEMALE
No
Sponsors
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Clínica INEBIR
OTHER
Responsible Party
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Locations
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Universidad Pablo de Olavide
Seville, Andalusia, Spain
Countries
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Other Identifiers
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Endometriosis and dyspareunia
Identifier Type: -
Identifier Source: org_study_id
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