Therapeutic Exercise and Education in Pain Neurophysiology to Improve Pain Intensity in Women With Endometriosis. Clinical Trial.

NCT05682235 | Active Not Recruiting

• 1 other identifier: Endometriosis2022
• 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 improve pain intensity.

Conditions

Endometriosis

Keywords

Pain; Quality of life; Chronic pelvic pain; therapeutic exercise; pain neurophysiology; physiotherapy

Outcome Measures

Primary Outcomes (1)

• Changes in pain perception assessed using a 100mm Visual Analogue Scale (VAS)

  The scale will be administered by one of the researchers. Minimum value 0. Maximum value 100. Higher score = Higher level of pain. Lowe and lower scores mean a better result.

  Baseline, Up to 1 month, Up to 3 months

Secondary Outcomes (3)

• Changes in Kinesiofobia assessed using the Tampa Scale of Kinesiofobia (TSK)

  Baseline, Up to 1 month, Up to 3 months

• Changes in Catastrophism assesed using the Pain Catastrophism Scale (PCS)

  Baseline, Up to 1 month, Up to 3 months

• Impression of the overall improvement obtained with the treatment ussing the Global rating of changes scale (GROC)

  Up to 6 months

Study Arms (2)

Therapeutic Exercise AND Pain Neurophysiology Education

EXPERIMENTAL

Therapeutic exercise: Therapeutic exercise is the systematic and planned execution of posture movements and physical activities to correct or prevent alterations, improve or enhance physical functioning, prevent risk factors for solid and optimize 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 diminish the threatening meaning of pain.

Other: Therapeutic exercise AND pain neurophysiology education

Sham Comparator

SHAM COMPARATOR

Talks about healthy habits

Other: Sham

Interventions

Therapeutic exercise AND pain neurophysiology education OTHER

A program of therapeutic exercise and education in the neurophysiology of pain will be applied to the participants of the experimental group and talks on healthy habits to the placebo group participants.

Therapeutic Exercise AND Pain Neurophysiology Education

Sham OTHER

Talk 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 study.

Sponsors & Collaborators

• University of Valladolid: lead

Study Sites (1)

University of Valladolid

Valladolid, 47002, Spain

Location

MeSH Terms

Conditions

Endometriosis; Pain

Interventions

Exercise Therapy; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Sandra Jímenez, Doctor

  University of Valladolid

  STUDY DIRECTOR

• Luis Ceballos Laita, Doctor

  University 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: Doctorate Student

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

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 12, 2023
• Study Start: December 12, 2022
• Primary Completion: October 12, 2024
• Study Completion: March 12, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)