Chronic PainNCT03613012
Pain Index Extracted From EEG in Monitoring Chronic Pain
An observational study of Chronic Pain and Pain Assessment, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain, Pain Assessment
- What is being tested?
- Pain index
- How many people
- 111 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2018to 10 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100043
About this study
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.
Read the 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.
- Conditions
- Chronic Pain, Pain Assessment
- Being tested
- Pain index
- Keywords
- Pain assessment, electroencephalographic, numerical rating scale, pain index
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain indexDiagnostic test
Record the patients' EEG and extract pain index before and after pain treatments
| Study group | Role | What they receive |
|---|---|---|
| Pain index | Pain index will be extracted from the EEG of chronic pain patients before and after pain treatments Receives: Diagnostic Test: Pain index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain index
Pain index is extracted from EEG accessed by a multifunctional monitor HXD-1
Measured: 30 mins after treatment
Secondary outcomes (1)
Hamilton Anxiety and Depression Scale(HADS)
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start6 Aug 2018
- Primary completion2 Nov 2018
- Study completion10 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yifeng, Peking University People's Hospital
- Investigators
- Yi Feng, MD, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613012
- Sponsor's protocol ID
- RMYYMZK-5590
- Status last verified
- Nov 2018
- First submitted
- 11 Jul 2018
- Last updated
- 30 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Index Extracted From EEG in Monitoring Chronic Pain
- ClinicalTrials.gov ID
- NCT03613012
- Acronym / sponsor ID
- RMYYMZK-5590
- Conditions
- Chronic Pain, Pain Assessment
- Keywords
- Pain assessment, electroencephalographic, numerical rating scale, pain index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 10 Nov 2018 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain index | – | Diagnostic Test: Pain indexPain index will be extracted from the EEG of chronic pain patients before and after pain treatments |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain indexRecord the patients' EEG and extract pain index before and after pain treatments | Diagnostic test | Pain index |
Primary outcome
Pain index
Time frame: 30 mins after treatment
Pain index is extracted from EEG accessed by a multifunctional monitor HXD-1
1 secondary outcome
Hamilton Anxiety and Depression Scale(HADS)
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Feng, MD study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Pain Assessment, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain index (time frame: 30 mins after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018.