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临床试验/NCT04634955
NCT04634955已完成不适用

Comparison of Intravascular Incidence With Different Fluoroscopic Approach Method During S1 Trasnforaminal Injection

Keimyung University Dongsan Medical Center2 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2020年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
149
试验地点
2
主要终点
intravascular incidence

研究概览

简要总结

Intravascular incidence during S1 transforaminal injection is known to be higher than lumbar injection. Its incidence is reported to be 15~25%.

This study was aimed to see if there is any benefit of reducing the intravasuclar injection rate when S1 transforaminal injection was performed by different fluorosopic approach.

详细描述

Fluorosocpically guided transforaminal epidural steroid injection is a popular interventional procedure that is effective in radicular pain conditions such as herniated interverebral disc, spinal stenosis and failed back surgery syndrome.

The incidence of inadvertent intravascular needle injection during lumbar transforaminal injection is reported as from 9.9% to 30.8%. In particular, S1 intravascular injection rate is more frequent than at the lumbar level.

Previous study reported that guiding the needle toward the S1 foramen using the S1 scotty dog image as a bony landmark, not in the classic way, but in an oblique fluoroscopic view, during L5 and S1 transforaminal epidural steroid injection, can save procedure time and reduce the risk of radiation exposure.

In this stidy, the investigators aimed to compare the incidence of intravascular injection rate by anteroposterior and oblique view approaches for S1 transforaminal epidural steroid injection. In addition, the investigators also compared the procedure time and radiation exposure between two approach method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • spinal stenosis
  • herniated intervertebral disc
  • failed back surgery syndrome

排除标准

  • coagulopathy
  • infection

结局指标

主要结局

intravascular incidence

时间窗: 15 minutes after the completion of the intervention

intravascular injection rate

次要结局

  • procedure time(15 minutes after the completion of the intervention)
  • radiation dose(15 minutes after the completion of the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ji Hee Hong

Principal Investigator

Keimyung University Dongsan Medical Center

研究点 (2)

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