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

Therapeutic Exercise and Education in Neurophysiology of Pain in the Quality of Life of 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 achieve improvement in quality of life.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis
• Intervention / Treatment: Other: Physiotherapy; Other: Sham, Control

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: REBECA ABRIL, Doctoral Student; Phone Number: +34 676434719; Email: rebeca.abril@hotmail.com
• Study Contact Backup: Name: MARTA CORREYERO, Doctor; Phone Number: +34 655614989; Email: marta.correyero@uva.es

Study Locations

• Spain
  • Soria, Spain, 42001
    • Recruiting
    • SBFisioterapia
    • Contact: Sandra Bachiller, Physiotherapist; Phone Number: +34 677231049

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapeutic Exercise and Pain Neurophysiology Education; Therapeutic exercise is the systematic and planned execution of posture movements and physical activities to correct or prevent alterations, improve or enhance physical functioning, and prevent risk factors for solid and optimized overall health status. Pain Neurophysiology Education: Education in pain neurophysiology consists in describing to the patient the neurobiology and neurophysiology of his nervous system pain to improve the processing of it and decrease the threatening meaning of pain.	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 Comparator: Sham Comparator; Talks about healthy habits	Other: Sham, Control; Talks about healthy habits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of Valladolid
• Investigators: Study Director: SANDRA JIMENEZ, Doctor, University of Valladolid

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Anticipated): October 12, 2023
• Study Completion (Anticipated): January 12, 2024

Study Registration Dates

• First Submitted: December 28, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 14, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: EndometriosisCdV2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No