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

NCT05679063 | Completed

• 1 other identifier: EndometriosisCdV2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Changes in quality of life perception assessed using EUROQuOL 5D - 5L

  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.

  Baseline, Up to 1 month, Up to 3 months.

Secondary Outcomes (3)

• Abdominal wall muscle thickness

  Baseline, Up to 1 month, Up to 3 months

• Sexual Function assessed usinf Female Sexual Function Index (IFSF)

  Baseline, Up to 1 month, Up to 3 months

• Symptoms associated with menstruation assessed using CVM-22 (quality of life related to menstruation)

  Baseline, up to 1 month, up to 3 months

Study Arms (2)

Therapeutic Exercise and Pain Neurophysiology Education

EXPERIMENTAL

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.

Other: Physiotherapy

Sham Comparator

SHAM COMPARATOR

Talks about healthy habits

Other: Sham, Control

Interventions

Physiotherapy OTHER

A program of therapeutic exercise and education in the neurophysiology of pain will be applied to the participants of the experimental group

Therapeutic Exercise and Pain Neurophysiology Education

Sham, Control OTHER

Talks about healthy habits

Sham Comparator

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valladolid: lead

Study Sites (1)

SBFisioterapia

Soria, Soria, 42001, Spain

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Physical Therapy Modalities; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• SANDRA JIMENEZ, Doctor

  University of Valladolid

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants will not know in which treatment group they are, and the investigator in charge of carrying out the evaluation will not know to which group the subjects he evaluates belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Trough a randomization program, participants will be assigned to the treatment group or the control group.

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 10, 2023
• Study Start: December 29, 2022
• Primary Completion: October 12, 2024
• Study Completion: May 1, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

ES (1)