Therapeutic Exercise and Education in Neurophysiology of Pain in the Quality of Life of Women With Endometriosis: Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Valladolid
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Changes in quality of life perception assessed using EUROQuOL 5D - 5L
Study Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The participants will not know in which treatment group they are, and the investigator in charge of carrying out the evaluation will not know to which group the subjects he evaluates belong to.
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Physiotherapy (Other)
Sham Comparator
Talks about healthy habits
Intervention: Sham, Control (Other)
Outcomes
Primary Outcomes
Changes in quality of life perception assessed using EUROQuOL 5D - 5L
Time Frame: Baseline, Up to 1 month, Up to 3 months.
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.
Secondary Outcomes
- Abdominal wall muscle thickness(Baseline, Up to 1 month, Up to 3 months)
- Sexual Function assessed usinf Female Sexual Function Index (IFSF)(Baseline, Up to 1 month, Up to 3 months)
- Symptoms associated with menstruation assessed using CVM-22 (quality of life related to menstruation)(Baseline, up to 1 month, up to 3 months)
Investigators
Rebeca Abril Coello
Principal investigator
University of Valladolid