Back to resultsTherapeutic Exercise and Education in Neurophysiology of Pain in the Quality of Life of Women With Endometriosis
Primary Purpose
Endometriosis
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physiotherapy
Sham, Control
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis
Eligibility Criteria
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
Sites / Locations
- SBFisioterapiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Therapeutic Exercise and Pain Neurophysiology Education
Sham Comparator
Arm Description
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.
Talks about healthy habits
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Abdominal wall muscle thickness
The muscle thickness of the abdominal wall with ultrasound according to a defined protocol.
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
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
Full Information
NCT ID
NCT05679063
First Posted
December 28, 2022
Last Updated
January 14, 2023
Sponsor
University of Valladolid
1. Study Identification
Unique Protocol Identification Number
NCT05679063
Brief Title
Therapeutic Exercise and Education in Neurophysiology of Pain in the Quality of Life of Women With Endometriosis
Official Title
Therapeutic Exercise and Education in Neurophysiology of Pain in the Quality of Life of Women With Endometriosis: Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
October 12, 2023 (Anticipated)
Study Completion Date
January 12, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valladolid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Trough a randomization program, participants will be assigned to the treatment group or the control group.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic Exercise and Pain Neurophysiology Education
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Comparator
Arm Type
Sham Comparator
Arm Description
Talks about healthy habits
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
A program of therapeutic exercise and education in the neurophysiology of pain will be applied to the participants of the experimental group
Intervention Type
Other
Intervention Name(s)
Sham, Control
Intervention Description
Talks about healthy habits
Primary Outcome Measure Information:
Title
Changes in quality of life perception assessed using EUROQuOL 5D - 5L
Description
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.
Time Frame
Baseline, Up to 1 month, Up to 3 months, Up yo 6 months.
Secondary Outcome Measure Information:
Title
Abdominal wall muscle thickness
Description
The muscle thickness of the abdominal wall with ultrasound according to a defined protocol.
Time Frame
Baseline, Up to 1 month, Up to 3 months, Up to 6 months.
Title
Sexual Function assessed usinf Female Sexual Function Index (IFSF)
Description
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
Time Frame
Baseline, Up to 1 month, Up to 3 months, Up to 6 months.
Title
Symptoms associated with menstruation assessed using CVM-22 (quality of life related to menstruation)
Description
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
Time Frame
Baseline, up to 1 month, up to 3 months, up to 6 months.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Woman
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
REBECA ABRIL, Doctoral Student
Phone
676434719
Ext
+34
Email
rebeca.abril@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
MARTA CORREYERO, Doctor
Phone
655614989
Ext
+34
Email
marta.correyero@uva.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SANDRA JIMENEZ, Doctor
Organizational Affiliation
University of Valladolid
Official's Role
Study Director
Facility Information:
Facility Name
SBFisioterapia
City
Soria
ZIP/Postal Code
42001
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Bachiller, Physiotherapist
Phone
677231049
Ext
+34
12. IPD Sharing Statement
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Therapeutic Exercise and Education in Neurophysiology of Pain in the Quality of Life of Women With Endometriosis
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