NCT04968639招募中不适用
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.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Electroencephalogram analysis
研究概览
简要总结
The characteristic of axial pain and EEG analysis of patients after laminoplasty
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Electroencephalogram analysis
时间窗: 1 year after surgery.
Electroencephalogram analysis (focus on the gamma oscillation at prefrontal cortex) at 1-year follow-up.
Visual analogue scale for axial pain
时间窗: 1 year after surgery.
Visual analogue scale for axial pain before operation and at 1-year follow-up
次要结局
- Outcome of cervical spine function(1 year after surgery.)
- Trail Making Test(1 year after surgery.)
- Quality of life outcome(1 year after surgery.)
- Psychological measures(1 year after surgery.)
研究者
研究点 (2)
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