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Completed

NCT Number: NCT03613012

Pain Index Extracted From EEG in Monitoring Chronic Pain

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100043, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain index

Diagnostic Test

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

Primary outcomes

  1. Pain index

    Time frame: 30 mins after treatment

    Pain index is extracted from EEG accessed by a multifunctional monitor HXD-1

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2018
Registry last updated
Nov 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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