Back to resultsTherapeutic Exercise and Education in Pain Neurophysiology to Improve Pain Intensity in Women With Endometriosis. Clinical Trial.
Primary Purpose
Endometriosis
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic exercise AND pain neurophysiology education
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring Pain, Quality of life, Chronic pelvic pain, therapeutic exercise, pain neurophysiology, physiotherapy
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 study.
Sites / Locations
- University of Valladolid
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: Therapeutic exercise is the systematic and planned execution of posture movements and physical activities to correct or prevent alterations, improve or enhance physical functioning, prevent risk factors for solid and optimize 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 diminish the threatening meaning of pain.
Talks about healthy habits
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05682235
First Posted
December 26, 2022
Last Updated
January 13, 2023
Sponsor
University of Valladolid
1. Study Identification
Unique Protocol Identification Number
NCT05682235
Brief Title
Therapeutic Exercise and Education in Pain Neurophysiology to Improve Pain Intensity in Women With Endometriosis. Clinical Trial.
Official Title
Therapeutic Exercise and Education in Pain Neurophysiology to Improve Pain Intensity in Women With Endometriosis. Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
January 12, 2024 (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 improve pain intensity.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Pain, Quality of life, Chronic pelvic pain, therapeutic exercise, pain neurophysiology, physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Through 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:
Therapeutic exercise is the systematic and planned execution of posture movements and physical activities to correct or prevent alterations, improve or enhance physical functioning, prevent risk factors for solid and optimize 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 diminish 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)
Therapeutic exercise AND pain neurophysiology education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Talk about healthy habits
Primary Outcome Measure Information:
Title
Changes in pain perception assessed using a 100mm Visual Analogue Scale (VAS)
Description
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.
Time Frame
Baseline, Up to 1 month, Up to 3 months, Up yo 6 months.
Secondary Outcome Measure Information:
Title
Changes in Kinesiofobia assessed using the Tampa Scale of Kinesiofobia (TSK)
Description
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.
Time Frame
Baseline, Up to 1 month, Up to 3 months, Up to 6 months.
Title
Changes in Catastrophism assesed using the Pain Catastrophism Scale (PCS)
Description
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.
Time Frame
Baseline, Up to 1 month, Up to 3 months, Up to 6 months.
Title
Impression of the overall improvement obtained with the treatment ussing the Global rating of changes scale (GROC)
Description
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.
Time Frame
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 study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Jímenez, Doctor
Organizational Affiliation
University of Valladolid
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Luis Ceballos Laita, Doctor
Organizational Affiliation
University Valladolid
Official's Role
Study Director
Facility Information:
Facility Name
University of Valladolid
City
Valladolid
ZIP/Postal Code
47002
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data of the participants will only be kept by the study researchers.
Learn more about this trial
Therapeutic Exercise and Education in Pain Neurophysiology to Improve Pain Intensity in Women With Endometriosis. Clinical Trial.
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