Therapeutic Exercise and Education in Neurophysiology of Pain in the Quality of Life of Women With Endometriosis

Endometriosis Clinical Trial

Official title:

Therapeutic Exercise and Education in Neurophysiology of Pain in the Quality of Life of Women With Endometriosis: Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05679063
• Other study ID #: EndometriosisCdV2022
• Status: 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: REBECA ABRIL, Doctoral Student
• Phone: 676434719
• Email: rebeca.abril[@]hotmail.com
• 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 achieve improvement in quality of life.

Description:

A study will be carried out whose objective is to improve the quality of life in women with endometriosis through a program of therapeutic exercise and education in the neurophysiology of pain. Also as secondary variables will be observed: menstrual symptoms, sexual function, and abdominal wall thickness measured with ultrasound.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 12, 2024
• Est. primary completion date: October 12, 2023
• 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 stud

Related Conditions & MeSH terms

• Endometriosis

Intervention

Other:
• Physiotherapy
A program of therapeutic exercise and education in the neurophysiology of pain will be applied to the participants of the experimental group
• Sham, Control
Talks about healthy habits

Locations

Country	Name	City	State
Spain	SBFisioterapia	Soria

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 quality of life perception assessed using EUROQuOL 5D - 5L	The scale will be administered by one of the researchers, This scale covers five dimensions, each of which is assigned a score from 1 to 5, and with these scores, a code is obtained that indicates the person's quality of life. High values indicate poor quality of life.	Baseline, Up to 1 month, Up to 3 months, Up yo 6 months.
Secondary	Abdominal wall muscle thickness	The muscle thickness of the abdominal wall with ultrasound according to a defined protocol.	Baseline, Up to 1 month, Up to 3 months, Up to 6 months.
Secondary	Sexual Function assessed usinf Female Sexual Function Index (IFSF)	The scale will be administered by one of the researchers. This questionnaire consists of 19 questions and is grouped into six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain; each question has 5 or 6 options, assigning them a score ranging from 0 to 5. The score for each domain is multiplied by a factor and the result final is the arithmetic sum of the domains. A higher score better sexuality	Baseline, Up to 1 month, Up to 3 months, Up to 6 months.
Secondary	Symptoms associated with menstruation assessed using CVM-22 (quality of life related to menstruation)	The scale will be administered by one of the researchers. Minimin value = 0. Maximum value = 66. A high result indicates a good quality of life-related to menstruation	Baseline, up to 1 month, up to 3 months, up to 6 months.