Pain Index Extracted From EEG in Monitoring Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Pain index
研究概览
简要总结
Pain is a subjective feeling,and pain experts have been trying to assess it using objective methods. Pain index (PI) is extracted from electroencephalographic as an objective diagnostic tool for chronic pain. This study is a diagnostic test aims to explore the reliability and validity of PI, with numerical rating scale(NRS) as the gold standard.
详细描述
Chronic pain outpatients between 18 and 80 years old, NRS ≥4 at first visit and receive injection or shockwave therapy will be included. After informed consents signed, the age, gender, dominant hand and hospital anxiety and depression scale (HADS) will be collected. Each patient will be connected with a multifunctional monitor HXD-1 for 8 minutes to access EEG in a quiet environment before pain treatment and 30 minutes after pain treatment. NRS will also be recorded before pain treatment and 30 minutes after pain treatment. PI will be extracted from EEG by analysts.
In order to reduce environmental effects, the same quiet research environment will be used throughout the study. All data will be obtained and recorded by the same person, and all PI will be analyzed and calculated by the same person.
SPSS 20.0 will be used to analyze the data, Pearson's correlations and Kappa consistency test to analyze the validity and reliability of PI. The receiver operating characteristic curve will be use to analyze the sensitivity and specificity of PI to evaluating moderate and severe pain(NRS≥4). A multiple linear regression equation with PI as dependent variable and anxiety score and depression score as independent variables will be used to evaluate the influence of anxiety and depression on PI.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.chronic pain patients diagnosed lumbar disc herniation, osteoarthritis or other chronic pain diseases, who will received injection therapy or shockwave therapy at clinic.
- •2.patients age 18-80 years-old
- •3.patients with an NRS pain score ≥ 4,
- •4.patients who voluntarily participate in the test and sign the informed consent forms.
排除标准
- •1.patients with central nervous system disorders, such as epilepsy, cerebral infarction, or cerebral hemorrhage,
- •2.patients with mental disorders,
- •3.patients with a history of long-term use of psychotropic drugs.
- •4.patients who can't understand NRS.
结局指标
主要结局
Pain index
时间窗: 30 mins after treatment
Pain index is extracted from EEG accessed by a multifunctional monitor HXD-1
次要结局
- Hamilton Anxiety and Depression Scale(HADS)(baseline)
研究者
yifeng
Chief Physician
Peking University People's Hospital