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NCT Number: NCT05682235

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Valladolid

Valladolid, 47002, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

SHAM

Other

Talk about healthy habits

Primary outcomes

  1. 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

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

    Time frame: 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.

  2. Changes in Catastrophism assesed using the Pain Catastrophism Scale (PCS)

    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 52. Higher score = Higher level of catastrophism. Lower and lower scores mean better results.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Valladolid

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jan 12, 2023
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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