Complex Regional Pain Syndrome in Children: Impact of Bergès Relaxation on the Autonomic Balance
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- high frequency index
研究概览
简要总结
Complex regional pain syndrome (CRPS) is a disease provoking chronic pain in the limbs, following a trauma. Patient care is complicated by the variable clinical picture and response to treatment. The stress level of the organization, for chronic pain impacts the regulation of the autonomic balance. The study of time and frequency domain analysis of Heart Rate Variability (HRV) allows non-invasive and reproducible assessment of the autonomic balance.
详细描述
The hypothesis in this study is that the sympathovagal balance could be altered in children with CRPS. But the impact of relaxation on pain and balance has been proven. This study aims to assess the impact of the assumption by the relaxation therapy in children suffering from CRPS, on sympathovagal balance.
It is an experimental prospective single-center study to highlight after a standardized relaxation program, changes in the time and frequency indices variability in heart rate, parameters of pain and quality of life with the CRPS children 6 to 16 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents affiliates or entitled to a social security scheme
- •Children from 6 to 16 years with Complex Regional Pain Syndrome (CRPS) type 1
- •Diagnosis according to the Budapest criteria.
排除标准
- •Child with pathologies reaching the central nervous system or the brain stem.
- •Children with a severe pathology of cardio-respiratory or heart being referred to treatment.
- •Children requiring emergency surgery or trauma or septic or inflammatory context.
- •Children with some psychiatric diseases
- •Children who no understand french enough
研究组 & 干预措施
Complex Regional Pain Syndrome (CRPS)
Children 6 to 12 years old child with Complex Regional Pain Syndrome (CRPS) type 1 will be included.
They will have questionnaires, holter electrocardiogram, blood pressure and relaxation sessions.
干预措施: questionnaires (Diagnostic Test)
Complex Regional Pain Syndrome (CRPS)
Children 6 to 12 years old child with Complex Regional Pain Syndrome (CRPS) type 1 will be included.
They will have questionnaires, holter electrocardiogram, blood pressure and relaxation sessions.
干预措施: holter electrocardiogram (Diagnostic Test)
Complex Regional Pain Syndrome (CRPS)
Children 6 to 12 years old child with Complex Regional Pain Syndrome (CRPS) type 1 will be included.
They will have questionnaires, holter electrocardiogram, blood pressure and relaxation sessions.
干预措施: blood pressure (Diagnostic Test)
Complex Regional Pain Syndrome (CRPS)
Children 6 to 12 years old child with Complex Regional Pain Syndrome (CRPS) type 1 will be included.
They will have questionnaires, holter electrocardiogram, blood pressure and relaxation sessions.
干预措施: relaxation sessions (Other)
结局指标
主要结局
high frequency index
时间窗: at 3 months
measured by holter electrocardiogram.
次要结局
- life quality of children(at 3 months)
- intensity of pain(at 3 months)
- location of pain(at 3 months)
- blood pressure(at 3 months)
- evaluation of pain(at 3 months)