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临床试验/NCT05290779
NCT05290779已完成不适用

Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection for Treatment of Radicular Pain

Minia University2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2021年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
2
主要终点
improvement of visual analogue score of pain

研究概览

简要总结

The study is conducted to compare pain relief, accuracy and safety and radiation exposure of selective lumbar nerve root injection for lumbar radicular pain using ultrasound guidance versus fluoroscopy guidance

详细描述

Radicular pain is believed to be induced by irritation or inflammation of a nerve root caused by mechanical pressure or chemical irritation from degeneration herniation or rupture of intervertebral disc .Nerve root steroid injection is the most commonly performed minimally invasive technique for treatment of radicular pain in lumbar spine.The mechanism of action of steroids is to reduce inflammation by reduction in proinflammatory mediators around the nerve root, causing reduction in pain levels . Although Fluoroscopy guided technique is the most widely accepted method in lumbar selective nerve root injection, but recently ultrasound technique has gained acceptance among physicians due its reliability, efficacy, real-time guidance of injection and reduction of radiation exposure. Real-time guidance of injection provided by ultrasonography allows for good identification of the spinous process and adjacent structures such as lamina, zygapophyseal articulations and transverse process allowing for safer and potentially equally effective injection technique. The patients are randomly allocated into two groups; one group will receive injection under fluoroscopy guidance and the other group will receive injection under ultrasound guidance. The two groups are compared in terms of pain relief, accuracy and safety and radiation exposure.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients aged 18-60 years .
  • Both sexes .
  • With unilateral chronic lumbar radicular pain for more than 3 months.
  • Cooperative and oriented patients.
  • All patients are diagnosed by a neurologist for radicular low back pain through clinical presentation, medical examinations, computed tomography (CT), or magnetic resonance imaging (MRI).

排除标准

  • Uncontrolled diabetes.
  • Infection at the site of injection.
  • Spine fractures.
  • Previous back surgery.
  • Progressive neurologic disorders.
  • Peripheral neuropathy.
  • Presence of motor or sphencteric disturbance.
  • Bilateral radicular pain.
  • Allergy to substance of injection.
  • Patients with body mass index (BMI) more than 35.

结局指标

主要结局

improvement of visual analogue score of pain

时间窗: 3 months

evaluation of pain relief using visual analogue score on a scale from 0 to 10 with higher scores mean worse outcome

improvement of Oswestry disability index score for back pain

时间窗: 3 months

evaluation of pain relief using Oswestry disability index score on a scale from 0% to 100% with the higher scores mean worse outcome.

次要结局

  • safety of technique(3 months)
  • radiation exposure(1 hour)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Islam Ahmed Bakr Mohammed

Director

Minia University

研究点 (2)

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