Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection for Treatment of Radicular Pain
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
- 否
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
Islam Ahmed Bakr Mohammed
Director
Minia University
