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

The objective of this study will be to evaluate treatment using ET exercise and pain education in women with endometriosis to improve pain intensity.

Study Overview

• Status: Active, not recruiting
• Conditions: Endometriosis
• Intervention / Treatment: Other: Therapeutic exercise AND pain neurophysiology education; Other: Sham

Detailed Description

A study will be carried out whose objective is to improve the intensity of pain in women with endometriosis through a program of therapeutic exercise and education in the neurophysiology of pain. Also as secondary variables will be observed: kinesiophobia, catastrophism and impression of global improvement with treatment.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valladolid, Spain, 47002
    • University of Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Comparator; Talks about healthy habits	Other: Sham; Talk about healthy habits
Experimental: Therapeutic Exercise AND Pain Neurophysiology Education; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impression of the overall improvement obtained with the treatment ussing the Global rating of changes scale (GROC)	The scale will be administered by one of the researchers. Minimum value -7. Maximum value 7. Higher score = Increased improvement with treatment. Lower scores = 45 / 5.000 Resultados de traducción Resultado de traducción worsening of the patient with treatment.	Up to 6 months
Changes in Kinesiofobia assessed using the Tampa Scale of Kinesiofobia (TSK)	The scale will be administered by one of the researchers. Minimum value 11. Maximum value 44. Higher score = Higher level of kinesiophobia. Lower and lower scores mean better results.	Baseline, Up to 1 month, Up to 3 months
Changes in Catastrophism assesed using the Pain Catastrophism Scale (PCS)	The scale will be administered by one of the researchers. Minimum value 0. Maximum value 52. Higher score = Higher level of catastrophism. Lower and lower scores mean better results.	Baseline, Up to 1 month, Up to 3 months

Collaborators and Investigators

• Sponsor: University of Valladolid
• Investigators: Study Director: SANDRA JIMENEZ, Doctor, University of Valladolid; Study Director: Luis Ceballos Laita, Doctor, University Valladolid

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Actual): October 12, 2024
• Study Completion (Estimated): March 12, 2025

Study Registration Dates

• First Submitted: December 26, 2022
• First Submitted That Met QC Criteria: December 26, 2022
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Quality of life; physiotherapy; therapeutic exercise; Chronic pelvic pain; pain neurophysiology
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Pain; Endometriosis
• Other Study ID Numbers: Endometriosis2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data of the participants will only be kept by the study researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No