Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain
• Interventions: Drug: Remifentanil (Target-Controlled Infusion); Drug: Flurbiprofen (Single intravenous injection); Other: No intervention; Drug: Esketamine(Continuous infusion); Device: Spinal Cord Stimulation

• Registration Number: NCT06531837
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-07-29
• Status Verified: 2024-08
• Study First Posted: 2024-08-01
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13
• Study Start: 2024-08-25
• Primary Completion: 2026-01-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 18 - 65 years old;
• American Society of Anesthesiologists (ASA) I-III;
• Dextromanual;
• Chronic Pain following Spinal Cord Injury;
• Spinal cord electrical stimulator implantation under general anesthesia;
• Signed informed consent.

Exclusion Criteria

• People with mental and behavioral disorders.
• Previous history of craniocerebral disease;
• History of drug and alcohol abuse;
• Patients with aphasia or inability to cooperate with the pain assessments;
• Previous adverse reaction to esketamine, opioids or NSAIDs;
• Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
• Patients with myasthenia gravis, bronchial asthma, or a predisposition to respiratory depression;
• Bleeding tendency;
• BMI ≥ 35 kg/m²;
• Pregnancy or lactation.

Spinal Cord Injury Patients Without Pain

Inclusion Criteria:

• Age 18 - 65 years old;
• American Society of Anesthesiologists (ASA) I-III;
• Dextromanual;
• Spinal Cord Injury Patients Without Pain;
• Spinal cord electrical stimulator implantation under general anesthesia;
• Signed informed consent.

Exclusion Criteria:

• People with mental and behavioral disorders.
• Previous history of craniocerebral disease;
• History of drug and alcohol abuse;
• Patients with aphasia or inability to cooperate with the pain assessments;
• Previous adverse reaction to esketamine, opioids or NSAIDs;
• Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
• Patients with myasthenia gravis, bronchial asthma, or a predisposition to respiratory depression;
• Bleeding tendency;
• BMI ≥ 35 kg/m²;
• Pregnancy or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with chronic pain treated with remifentanil	Spinal Cord Stimulation	-
Patients with chronic pain treated with remifentanil	Remifentanil (Target-Controlled Infusion)	-
Patients with chronic pain treated with flurbiprofen	Flurbiprofen (Single intravenous injection)	-
Patients without pain	No intervention	-
Patients with chronic pain treated with esketamine	Esketamine(Continuous infusion)	-
Patients with chronic pain treated with esketamine	Spinal Cord Stimulation	-
Patients with chronic pain treated with flurbiprofen	Spinal Cord Stimulation	-

Primary Outcome Measures

Name	Time	Method
EEG Spectral Characteristics	During the trial(up to 3 hours for each subject).	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.

Secondary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder(GAD-7)	During the trial(through study completion, 7 days)	The GAD-7 scale ranges from 0 to 21 points, with a higher score indicating a higher level of anxiety.
Patient Health Questionnaire-9(PHQ-9)	During the trial(through study completion, 7 days)	The PHQ-9 scale ranges from 0 to 27 points, with a higher score indicating a higher level of depression.
Numeric Rating Scale(NRS)	During the trial(through study completion, 7 days)	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.

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, China