Correlation of Intravascular Injection Rate and Severity of Cervical Neural Foraminal Stenosis During Cervical Transforaminal Epidural Steroid Injection: a Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Intravascular injection
研究概览
简要总结
This study evaluates whether there is a correlation between intravascular injection rate and severity of cervical foraminal stenosis during cervical transforaminal epidural steroid injection
详细描述
Cervical transforaminal epidural steroid injection (CTFESI) is useful option to improve cervical radicular pain. However, severe complication can occur by CTFESI such as epidural hematomas, infection, inadvertent intramedullary cord injections, and embolic infarct when inadvertent intra-arterial injection of particulate steroids has occurred.
The incidence of intravascular injection during CTFESI was known as 20.6% ~ 32.8% and it is higher than other level of spinal transforaminal epidural injection.
To avoid complication due to intravascular injection during CTFESI, risk factors was should be evaluated. However, there was no study about risk factors of intravascular injection during CTFESI. The investigators could assume the severity of cervical neural foraminal spinal stenosis could affect the incidence of intravascular injection, pain intensity and effectiveness during CTFESI.
Thus, the investigators designed this study to investigate whether there is a correlation between intravascular injection rate and severity of cervical foraminal stenosis during CTFESI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
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
- •Patients with radiating pain from cervical spinal stenosis and herniated nucleus pulposus.
排除标准
- •Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.
研究组 & 干预措施
Moderate stenosis
Moderate cervical neural foraminal stenosis is narrowest width of the neural foramen was >50% of the width of the width of the extraforaminal nerve root at the level of the anterior margin of the superior articular process.
干预措施: Cervical transforaminal epidural steroid injection (Procedure)
Severe stenosis
Severe cervical neural foraminal stenosis is narrowest width of the neural foramen was ≤50% of the extraforaminal nerve root width
干预措施: Cervical transforaminal epidural steroid injection (Procedure)
结局指标
主要结局
Intravascular injection
时间窗: During procedure
Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy
次要结局
- Pain intensity(Before treatment and at 1 month after treatment)
研究者
Saeyoung Kim, MD, PhD
Associate professor
Kyungpook National University Hospital