Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Visual Analogue Score change at 30 minutes post infiltration when compared to baseline
研究概览
简要总结
Chronic cervicobrachialgia is a public health problem. Epidural injections of corticosteroids and local anesthesics via transforaminal and interlaminar routes both have shown their potential in its treatment. The interlaminar approach offers the advantage of an epidural injection (i.e., direct contact with the nerve root in the epidural space). However, it requires fluoroscopy and can lead to potentially serious complications (compression of the nerve root, spinal cord injury...). The ultrasound-guided injection of corticosteroids via the transforaminal route, which offers the advantage of selectively targeting the symptomatic nerve root, may have the same therapeutic advantages as the interlaminar approach in decreasing unilateral cervicobrachial pain (i.e. a decrease in pain after infiltration) and reduce its risks.The aim of this study is to compare the efficacy of transforaminal vs interlaminar cervical corticosteroid injection.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status (ASA) I-III
- •Chronic unilateral cervicobrachial pain
- •Allowed Steroid infiltration
排除标准
- •Pregnancy
- •Lactation
- •Allergy or intolerance to any of the drugs/materials used in this study,
- •Participation in another interventional study
- •Systemic anticoagulation,
- •Infection at the puncture site
- •Patient refusal.
结局指标
主要结局
Visual Analogue Score change at 30 minutes post infiltration when compared to baseline
时间窗: up to 30 minutes
Pain will be evaluated by Visual Analog Scale (VAS) before and 30 minutes after corticosteroid infiltration. Visual Analog pain score (scale = 0 no pain; 10= worst pain imaginable)
次要结局
- Rate of Procedure failure(up to 30 minutes)
- Incidence of Adverse effects (lipothymia, nausea, vomiting)(up to 1 month)
- Visual Analogue Score change at 1 month post infiltration when compared to baseline(up to 1 month)
- Neck disability index (NDI) score (questionnaire)(up to 1 month)
- Patient satisfaction during procedure(at the end of infiltration)
- Incidence of complications (stroke, hematoma, paralysis)(up to 1 month)