Therapeutic Exercise and Education in Pain Neurophysiology to Improve Pain Intensity in Women With Endometriosis. Clinical Trial.

Sponsor
University of Valladolid (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05682235
Collaborator
(none)
60
1
2
13
4.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Therapeutic exercise AND pain neurophysiology education
  • Other: Sham
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Through a randomization program, participants will be assigned to the treatment group or the control group.Through a randomization program, participants will be assigned to the treatment group or the control group.
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.
Primary Purpose:
Treatment
Official Title:
Therapeutic Exercise and Education in Pain Neurophysiology to Improve Pain Intensity in Women With Endometriosis. Clinical Trial.
Actual Study Start Date :
Dec 12, 2022
Anticipated Primary Completion Date :
Jan 12, 2024
Anticipated Study Completion Date :
Jan 12, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Therapeutic Exercise AND Pain Neurophysiology Education

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.

Other: Therapeutic exercise AND pain neurophysiology education
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.

Sham Comparator: Sham Comparator

Talks about healthy habits

Other: Sham
Talk about healthy habits

Outcome Measures

Primary Outcome Measures

  1. Changes in pain perception assessed using a 100mm Visual Analogue Scale (VAS) [Baseline, Up to 1 month, Up to 3 months, Up yo 6 months.]

    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

  1. Changes in Kinesiofobia assessed using the Tampa Scale of Kinesiofobia (TSK) [Baseline, Up to 1 month, Up to 3 months, Up to 6 months.]

    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.

  2. Changes in Catastrophism assesed using the Pain Catastrophism Scale (PCS) [Baseline, Up to 1 month, Up to 3 months, Up to 6 months.]

    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.

  3. Impression of the overall improvement obtained with the treatment ussing the Global rating of changes scale (GROC) [Up to 6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
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 study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Valladolid Valladolid Spain 47002

Sponsors and Collaborators

  • University of Valladolid

Investigators

  • Study Director: Sandra Jímenez, Doctor, University of Valladolid
  • Study Director: Luis Ceballos Laita, Doctor, University Valladolid

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rebeca Abril Coello, Doctorate Student, University of Valladolid
ClinicalTrials.gov Identifier:
NCT05682235
Other Study ID Numbers:
  • Endometriosis2022
First Posted:
Jan 12, 2023
Last Update Posted:
Jan 17, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rebeca Abril Coello, Doctorate Student, University of Valladolid
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 17, 2023