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临床试验/NCT05679063
NCT05679063已完成不适用

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

University of Valladolid2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年12月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Changes in quality of life perception assessed using EUROQuOL 5D - 5L

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Changes in quality of life perception assessed using EUROQuOL 5D - 5L

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebeca Abril Coello

Principal investigator

University of Valladolid

研究点 (2)

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