Therapeutic Exercise and Education in Neurophysiology of Pain in the Quality of Life of Women with Endometriosis

Not Applicable

Active, not recruiting

• Conditions: Endometriosis
• Interventions: Other: Sham, Control; Other: Physiotherapy

• Registration Number: NCT05679063
• Lead Sponsor: University of Valladolid

Brief Summary

The objective of this study will be to evaluate treatment using ET exercise and pain education in women with endometriosis to achieve improvement in quality of life.

Detailed Description

A study will be carried out whose objective is to improve the quality of life in women with endometriosis through a program of therapeutic exercise and education in the neurophysiology of pain. Also as secondary variables will be observed: menstrual symptoms, sexual function, and abdominal wall thickness measured with ultrasound.

Study Timeline

• Study Start: 2022-12-12
• Study First Submitted: 2022-12-28
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-10
• Primary Completion: 2024-10-12
• Status Verified: 2025-01
• Study Completion: 2025-03-12
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Women of reproductive age between 18 and 45 years.
• Women with a medical diagnosis of endometriosis.
• Women with visual analog scale (EVA) between 4 and 10 (moderate-severe pain) during the last 3 months in the suprapubic area, abdomen or perineum both continuously and intermittently.

Exclusion Criteria

• Women who must have surgery during the study.
• Women who have undergone abdominal or pelvic surgery or who have given birth (vaginal or cesarean) in the last 6 months.
• Women who are pregnant or planning a pregnancy.
• Women with uncorrected pacemakers or coagulopathies, severe comorbid disorder, cancer (in the last 5 years or at present), severe mental disorders, or neuropathies affecting the nerves of the pelvis or lower extremities.
• Physiotherapy treatments or treatments related to pathology or study areas 15 days prior to the beginning of the study.
• Variations in medication in the 3 months prior to the start of the stud

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Comparator	Sham, Control	Talks about healthy habits
Therapeutic Exercise and Pain Neurophysiology Education	Physiotherapy	Therapeutic exercise is the systematic and planned execution of posture movements and physical activities to correct or prevent alterations, improve or enhance physical functioning, and prevent risk factors for solid and optimized overall health status. Pain Neurophysiology Education: Education in pain neurophysiology consists in describing to the patient the neurobiology and neurophysiology of his nervous system pain to improve the processing of it and decrease the threatening meaning of pain.

Primary Outcome Measures

Name	Time	Method
Changes in quality of life perception assessed using EUROQuOL 5D - 5L	Baseline, Up to 1 month, Up to 3 months.	The scale will be administered by one of the researchers, This scale covers five dimensions, each of which is assigned a score from 1 to 5, and with these scores, a code is obtained that indicates the person's quality of life. High values indicate poor quality of life.

Secondary Outcome Measures

Name	Time	Method
Abdominal wall muscle thickness	Baseline, Up to 1 month, Up to 3 months	The muscle thickness of the abdominal wall with ultrasound according to a defined protocol.
Sexual Function assessed usinf Female Sexual Function Index (IFSF)	Baseline, Up to 1 month, Up to 3 months	The scale will be administered by one of the researchers. This questionnaire consists of 19 questions and is grouped into six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain; each question has 5 or 6 options, assigning them a score ranging from 0 to 5. The score for each domain is multiplied by a factor and the result final is the arithmetic sum of the domains. A higher score better sexuality
Symptoms associated with menstruation assessed using CVM-22 (quality of life related to menstruation)	Baseline, up to 1 month, up to 3 months	The scale will be administered by one of the researchers. Minimin value = 0. Maximum value = 66. A high result indicates a good quality of life-related to menstruation

Trial Locations

Locations (1)

SBFisioterapia; 🇪🇸 Soria, Spain