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临床试验/NCT03341182
NCT03341182已完成不适用

The Effects of Use of Mirror Image on Radiation Exposure During Fluoroscopically Guided Transforaminal Epidural Injection

Yonsei University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年12月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
radiation exposure time(second)

研究概览

简要总结

Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral radicular pain.

Tunnel view technique is the basis of X-ray assisted intervention. In this technique, it is necessary to handle the block needle in order to adjust the direction of needle to the tunnel view toward target. If a mirror is used during needle handling, overall procedure time and radiation exposure can be reduced.

详细描述

  1. A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be performed after receiving the informed consent of the patient.
  2. This study is single-blind because it is not possible to blind the practitioner performing the injection.
  3. Subjects were randomly assigned to the normal method group (group A) and the mirror use group (group B) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers.
  4. After the procedure, a resident who does not know of this study records the radiation exposure time displayed on the monitor and the overall procedure time

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

盲法说明

  1. The subjects were randomly assigned to normal method group (group A) and mirror use group (group B), and the assigned results are unknown.
  2. The Outcomes Assessor is not related to the study, and does not know its contents.

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Magnetic resonance imaging (MRI) and clinical manifestations of adult men and women over 20 years of age are eligible for radiculopathy due to back nerve root compression and subject to fluoroscopically guided lumbar transforaminal epidural Injection at the suspected spinal nerveroots level.

排除标准

  • Blood clotting disorder
  • Infection around the site
  • Contrast agent allergy
  • Uncontrolled cardiovascular, cerebrovascular, kidney disease
  • Past history of spinal surgery (ex, spinal fusion)
  • If can not block due to Non-cooperation with subjects (ex, if you can not take the stomach)
  • Patients taking narcotic analgesics

研究组 & 干预措施

normal method group (group A)

Active Comparator

A mirror is not used in tunnel view technique (conventional manner)

干预措施: conventional manner (Procedure)

mirror use group (group B)

Experimental

A mirror is used in tunnel view technique

干预措施: Fluoroscopically Guided Lumbar Transforaminal Epidural Injections (Procedure)

结局指标

主要结局

radiation exposure time(second)

时间窗: Immediately after the procedure

In both groups, overall procedure time recorded on the monitor is recorded after the procedure is over.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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