Peking University People's Hospital
Beijing, Beijing Municipality, 100043, China
NCT Number: NCT03613012
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.
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Notify Me18 year–80 year
All sexes
Observational
Beijing, Beijing Municipality, 100043, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Record the patients' EEG and extract pain index before and after pain treatments
Time frame: 30 mins after treatment
Pain index is extracted from EEG accessed by a multifunctional monitor HXD-1
Time frame: baseline
Validated Chinese version of Hamilton Anxiety and Depression Scale is completed by the trained doctor.The HAD scale contains two sub-scales of anxiety and depression, consisting of 14 items, of which 7 items are rated as depression, 7 items are assessed as anxiety.Each item is scored from 0 to 3 points.Therefore, the anxiety subscale ranges from 0 to 21,and higher values represent a worse outcome: 0~7:asymptomatic, 8~10:suspicious presence; 11 to 21: existed.The depression subscale is scored in the same way as the anxiety scale.
Peking University People's Hospital
Other
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