Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614465
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Multimodal Rehabilitation Programme on Epigenetic Biomarkers Quality of Life Sexual Function and Muscle Strength in Women With Dyspareunia and Endometriosis
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the impact of a multimodal rehabilitation programme on epigenetic biomarkers in saliva especially miR-21 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 particularly miR-21 quality of life sexual function and muscle strength in women with dyspareunia and endometriosis
Study Design 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 50 years old diagnosed with endometriosis with dyspareunia and chronic pelvic pain under hormonal treatment 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 126 women diagnosed with dyspareunia and endometriosis randomly divided into two groups 63 in the intervention group and 63 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 3 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 Seville CEIUS following the Declaration of Helsinki and Spanish regulations Law 142007 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 32018
Study Design 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 50 years old diagnosed with endometriosis with dyspareunia and chronic pelvic pain under hormonal treatment 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 126 women diagnosed with dyspareunia and endometriosis randomly divided into two groups 63 in the intervention group and 63 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 3 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 Seville CEIUS following the Declaration of Helsinki and Spanish regulations Law 142007 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 32018
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None