The Characteristic of Axial Pain and EEG Analysis of Patients After Laminoplasty

Study Overview
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Brief Summary
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The characteristic of axial pain and EEG analysis of patients after laminoplasty

Detailed Description
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The characteristic of axial pain after open-door laminoplasty in patients with degenerative cervical spine myelopathy and the correlation with electroencephalogram analysis: a prospective cohort study.

Official Title
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The Characteristic of Axial Pain After Open-door Laminoplasty in Patients With Degenerative Cervical Spine Myelopathy and the Correlation With EEG Analysis: a Prospective Cohort Study.

Conditions
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Cervical Myelopathy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 70 years. Diagnosed as degenerative cervical spine myelopathy. Must receive C3-C7 open-door laminoplasty. Agree to join this study and sign the informed consent. Exclusion Criteria: Severe cervical spine kyphosis. Cervical spine radiculopathy. Laminoplasty with fusion. Cervical spine anterior column lesion because of tumor, trauma or infection. Severe osteoporosis. Morbid obesity. patients with mental disorder. Pregnancy. History of infection within last 3 months. Severe nervous system disease. Abnormal laboratory report of liver function, kidney function and hematologic system. Poor compliance. Patients with other surgical contraindications. Patients with intemperance or taking drugs. Patients who joined other study within the last 3 months. Patients with a chief complaint of neck pain (VAS score ≥3 points). Left handedness.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Axial pain positive group<br>Postoperative VAS score ≥ 3 points at 3-month follow-up | |
| Axial pain negative group<br>Postoperative VAS score ≤ 2 points at 3-month follow-up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroencephalogram analysis | Electroencephalogram analysis (focus on the gamma oscillation at prefrontal cortex) at 3-month follow-up. | 3 months after surgery. | 
| Electroencephalogram analysis | Electroencephalogram analysis (focus on the gamma oscillation at prefrontal cortex) at 1-year follow-up. | 1 year after surgery. | 
| Visual analogue scale for axial pain | Visual analogue scale for axial pain before operation and at 3-month follow-up | 3 months after surgery. | 
| Visual analogue scale for axial pain | Visual analogue scale for axial pain before operation and at 1-year follow-up | 1 year after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome of cervical spine function | Neck Disability Index score before operation and at 3-month follow-up | 3 months after surgery. | 
| Outcome of cervical spine function | Neck Disability Index score before operation and at 1-year follow-up | 1 year after surgery. | 
| Quality of life outcome | SF-36 score before operation and at 3-month follow-up | 3 months after surgery. | 
| Quality of life outcome | SF-36 score before operation and at 1-year follow-up | 1 year after surgery. | 
| Psychological measures | Beck Depression Inventory score before operation and at 3-month follow-up | 3 month after surgery. | 
| Psychological measures | Beck Depression Inventory score before operation and at 1-year follow-up | 1 year after surgery. | 
| Psychological measures | Beck Anxiety Inventory score before operation and at 3-month follow-up | 3 month after surgery. | 
| Psychological measures | Beck Anxiety Inventory score before operation and at 1-year follow-up | 1 year after surgery. | 
| Trail Making Test | Trail Making Test before operation and at 3-month follow-up | 3 month after surgery. | 
| Trail Making Test | Trail Making Test before operation and at 1-year follow-up | 1 year after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Myelopathy, Axial Pain, Electroencephalogram Analysis