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Clinical Trials/NCT05682235
NCT05682235
Active, Not Recruiting
N/A

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

University of Valladolid1 site in 1 country40 target enrollmentDecember 12, 2022
ConditionsEndometriosis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Endometriosis
Sponsor
University of Valladolid
Enrollment
40
Locations
1
Primary Endpoint
Changes in pain perception assessed using a 100mm Visual Analogue Scale (VAS)
Status
Active, Not Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 12, 2022
End Date
March 12, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rebeca Abril Coello

Doctorate Student

University of Valladolid

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • 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 Sites (1)

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