- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03613012
Pain Index Extracted From EEG in Monitoring Chronic Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100043
- Peking University People's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pain index
Pain index will be extracted from the EEG of chronic pain patients before and after pain treatments
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Record the patients' EEG and extract pain index before and after pain treatments
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain index
Time Frame: 30 mins after treatment
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Pain index is extracted from EEG accessed by a multifunctional monitor HXD-1
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30 mins after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamilton Anxiety and Depression Scale(HADS)
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.
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baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RMYYMZK-5590
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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