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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05682235
• Other study ID #: Endometriosis2022
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: January 12, 2024

Study information

• Verified date: January 2023
• Source: University of Valladolid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 12, 2024
• Est. primary completion date: January 12, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis
• Pain

Intervention

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.
• Sham
Talk about healthy habits

Locations

Country	Name	City	State
Spain	University of Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
University of Valladolid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, Up yo 6 months.
Secondary	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, Up to 6 months.
Secondary	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, Up to 6 months.
Secondary	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