Clinical Visibility of Combined Ultrasound and Fluoroscopy Guided Cervical Transforaminal Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- performance time in minutes
研究概览
简要总结
The combined use of Doppler ultrasound and fluoroscopy may increase efficacy and safety during cervical transforaminal epidural injection of steroid and local anaesthetic
The study will detect by which technique we have to start and confirm by the other to reach the favourable outcome.
详细描述
In a previous Ultrasound study involving the C5C6 levels, a performance time of 248.8 ± 82.7 seconds was reported. On the basis of these findings, a 30% difference in performance time would represent an effect size of 0.82 and would require 20 patients per group to achieve an alpha error of 0.05 and beta error of 0.1. For dropped cases; 5% will be added. So a total sample size of 64 patients (32 per group) will be required.
Statistical Analysis
will be performed using SPSS version 22 statistical software. For quantitative data, normality will be first assessed with the Shapiro test and then analyzed with the Student t-test. Data that will not have a normal distribution, as well as ordinal data, will be analyzed with the Mann-Whitney U test. For binomial data, Fisher exact test will be used. All P values presented will be 2-sided and values of less than 0.05 will be considered significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from radicular discogenic pain
- •Patients suffering from radicular foraminal pain Patients suffering from radicular pain secondary to spinal canal stenosis
- •Patients suffering from radicular pain after failed cervical disc surgery
- •Not responding to conservative management for at least 3 months
- •Patients with recalcitrant symptoms after transforaminal steroid injection.
- •American Society of Anesthesiology (ASA) from I to III
排除标准
- •Presence of local or systemic infection
- •Coagulopathy
- •Body mass index > 35
- •Cervical spine fracture
- •Myelopathy
- •Malignancy
- •Pregnancy
- •Patients unable to communicate with the operator during the procedure or report their pain diary after it.
- •Patients not responding to previous cervical transforaminal steroid injection or had any untoward effects.
- •Allergy to any one of the used medications.
结局指标
主要结局
performance time in minutes
时间窗: starting by direction of the spinal needle towards the nerve root till confirmation of correct placement of the needle and injection over a period of 15 minutes
Defined as time needed for correct transforaminal needle placement through ultrasound guidance followed by fluoroscopic confirmation or fluoroscopic guidance followed by ultrasound confirmation
次要结局
- Feasibility of the radiologic target(starting by direction of the spinal needle towards the nerve root till confirmation of correct placement of the needle and injection over a period of 15 minutes)
- Visual analogue score(pre-procedure then every 3 months till 6 months after the procedure)
- Neck disability index(pre-procedure then every 3 months till 6 months after the procedure)
- Level of patient satisfaction(pre-procedure then every 3 months till 6 months after the procedure)