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

NCT06614465 | Active Not Recruiting

• 1 other identifier: Endometriosis and dyspareunia
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multidisciplinary Communication

Keywords

Endometriosis; Dyspareunia; Multimodal Rehabilitation; Epigenetic Biomarkers; Quality of life; Sexual Function; Muscle Strength

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Systemic inflammation

  1 month

• Hormone Levels

  1 month

• Psychological condition

  1 month

• satisfaction with the intervention

  1 month

Study Arms (2)

1.Experimental Group

EXPERIMENTAL

The intervention group will receive a multimodal rehabilitation programme including therapeutic exercise, health education and manual therapy.

Other: Multimodal Rehabilitation

2.Control Group

NO INTERVENTION

The control group will not receive this intervention.

Interventions

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.

1.Experimental Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clínica INEBIR: lead

Study Sites (1)

Universidad Pablo de Olavide

Seville, Andalusia, 41013, Spain

Location

MeSH Terms

Conditions

Endometriosis; Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: January 8, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)