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The diagnosis of chronic pain currently lacks objective and quantifiable biomarkers. This study aims to observe the EEG characteristics of patients with chronic pain following spinal cord injury and subsequently administer analgesic interventions with remifentanil, esketamine, flurbiprofen, and spinal cord stimulation. The correlation between EEG features and pain intensity will be examined. The research aims to advance the objectification of chronic pain diagnosis and treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients without pain | Sham Comparator |
| |
| Patients with chronic pain treated with esketamine | Experimental |
| |
| Patients with chronic pain treated with remifentanil | Experimental |
| |
| Patients with chronic pain treated with flurbiprofen | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine(Continuous infusion) | Drug | Continuous intravenous infusion of esketamine at a dose of 0.2 mg/(kg · h). Collect resting-state EEG data and NRS scores 40 minutes after administration. |
| Measure | Description | Time Frame |
|---|---|---|
| EEG Spectral Characteristics | EEG power spectrum characteristics of chronic pain in patients with spinal cord injury under esketamine, remifentanil, flurbiprofen administration and spinal cord stimulation, including the δ, θ, α, β, and γ frequency bands. administration, including the δ, θ, α, β, and γ frequency bands. | During the trial(up to 3 hours for each subject). |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale(NRS) | Numerical Rating Scale Assessment Pre- and Post-Analgesic Treatment. The NRS ranges from 0 to 10, with 0-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain. | During the trial(through study completion, 7 days) |
| Generalized Anxiety Disorder(GAD-7) |
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Spinal Cord Injury Patients With Chronic Pain
Inclusion Criteria:
Exclusion Criteria:
Spinal Cord Injury Patients Without Pain
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruquan Han, M.D., Ph D | Contact | 8610-59976660 | ruquan.han@ccmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ruquan Han, M.D., Ph D | Beijing Tiantan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | 100070 | China |
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| Remifentanil (Target-Controlled Infusion) | Drug | The plasma drug concentrations of remifentanil were set at 0.5 ng/ml, 1 ng/ml, and 1.5 ng/ml. After each plasma drug concentration reached a steady state, the NRS scores were assessed, and resting-state EEG was recorded for at least 5 minutes. |
|
| Flurbiprofen (Single intravenous injection) | Drug | Single intravenous injection of Flurbiprofen at a dose of 100 mg. Collect resting-state EEG data and NRS scores 10 minutes after administration. |
|
| Spinal Cord Stimulation | Device | Collect resting-state EEG data and NRS scores with the spinal cord stimulator both turned off and on. |
|
| No intervention | Other | Collect resting-state EEG data and NRS scores. |
|
The GAD-7 scale ranges from 0 to 21 points, with a higher score indicating a higher level of anxiety. |
| During the trial(through study completion, 7 days) |
| Patient Health Questionnaire-9(PHQ-9) | The PHQ-9 scale ranges from 0 to 27 points, with a higher score indicating a higher level of depression. | During the trial(through study completion, 7 days) |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D005480 | Flurbiprofen |
| D007275 | Injections, Intravenous |
| D062187 | Spinal Cord Stimulation |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007267 | Injections |
| D004599 | Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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