Therapeutic Exercise and Education in Pain Neurophysiology to Improve Pain Intensity in Women With Endometriosis. Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in pain perception assessed using a 100mm Visual Analogue Scale (VAS)
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 improve pain intensity.
详细描述
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.
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
- 否
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 study.
结局指标
主要结局
Changes in pain perception assessed using a 100mm Visual Analogue Scale (VAS)
时间窗: Baseline, Up to 1 month, Up to 3 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.
次要结局
- Changes in Kinesiofobia assessed using the Tampa Scale of Kinesiofobia (TSK)(Baseline, Up to 1 month, Up to 3 months)
- Changes in Catastrophism assesed using the Pain Catastrophism Scale (PCS)(Baseline, Up to 1 month, Up to 3 months)
- Impression of the overall improvement obtained with the treatment ussing the Global rating of changes scale (GROC)(Up to 6 months)
研究者
Rebeca Abril Coello
Doctorate Student
University of Valladolid