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Pain Index Extracted From EEG in Monitoring Chronic Pain

NCT ID: NCT03613012

Last Updated: 2018-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-06

Study Completion Date

2018-11-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pain Pain Assessment

Keywords

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Pain assessment electroencephalographic numerical rating scale pain index

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pain index

Pain index will be extracted from the EEG of chronic pain patients before and after pain treatments

Pain index

Intervention Type DIAGNOSTIC_TEST

Record the patients' EEG and extract pain index before and after pain treatments

Interventions

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Pain index

Record the patients' EEG and extract pain index before and after pain treatments

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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yifeng

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Feng, MD

Role: STUDY_CHAIR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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RMYYMZK-5590

Identifier Type: -

Identifier Source: org_study_id