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

Not Applicable

Active, not recruiting

• Conditions: Endometriosis

• Registration Number: NCT05682235
• 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 improve pain intensity.

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 Timeline

• Study Start: 2022-12-12
• Study First Submitted: 2022-12-26
• Study First Submitted QC: 2022-12-26
• Study First Posted: 2023-01-12
• 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 study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in pain perception assessed using a 100mm Visual Analogue Scale (VAS)	Baseline, Up to 1 month, Up to 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Kinesiofobia assessed using the Tampa Scale of Kinesiofobia (TSK)	Baseline, Up to 1 month, Up to 3 months	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.
Changes in Catastrophism assesed using the Pain Catastrophism Scale (PCS)	Baseline, Up to 1 month, Up to 3 months	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.
Impression of the overall improvement obtained with the treatment ussing the Global rating of changes scale (GROC)	Up to 6 months	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.

Trial Locations

Locations (1)

University of Valladolid; 🇪🇸 Valladolid, Spain