Pain Index Extracted From EEG in Monitoring Chronic Pain

NCT03613012 | Completed

• 1 other identifier: RMYYMZK-5590
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Pain Assessment

Keywords

Pain assessment; electroencephalographic; numerical rating scale; pain index

Outcome Measures

Primary Outcomes (1)

• Pain index

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

  30 mins after treatment

Secondary Outcomes (1)

• Hamilton Anxiety and Depression Scale(HADS)

  baseline

Study Arms (1)

Pain index

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

Diagnostic Test: Pain index

Interventions

Pain index DIAGNOSTIC_TEST

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

Pain index

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The sample capacity calculation is based on the sensitivity/specificity of the diagnostic test allowed a minimum sensitivity of 80%, a minimum specificity of 80%, a significance level α of 0.01, an allowable error of 0.1 strictly.The estimated sample is 107 patients. Considering a predicted shedding rate of 10%, 118 patients will be enrolled.

You may qualify if:

• chronic pain patients diagnosed lumbar disc herniation, osteoarthritis or other chronic pain diseases, who will received injection therapy or shockwave therapy at clinic.
• patients age 18-80 years-old
• patients with an NRS pain score ≥ 4,
• patients who voluntarily participate in the test and sign the informed consent forms.

You may not qualify if:

• patients with central nervous system disorders, such as epilepsy, cerebral infarction, or cerebral hemorrhage,
• patients with mental disorders,
• patients with a history of long-term use of psychotropic drugs.
• patients who can't understand NRS.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100043, China

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yi Feng, MD

  Peking University People's Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: August 2, 2018
• Study Start: August 6, 2018
• Primary Completion: November 2, 2018
• Study Completion: November 10, 2018
• Last Updated: November 30, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)