The Effect of Combination of Ultrasound and Flouroscopy Guidance in Caudal Epidural Injections on Procedure Time and Radiation Exposure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Processing Time
研究概览
简要总结
The primary purpose of this study is to asses the effect of caudal epidural injection guided by a combination of ultrasound and fluoroscopy on the duration of the procedure and the amount of radiation exposed during the procedure, compared to the application of only fluoroscopy-guided.
Secondary aims are to reveal the presence of structural variations that prevent injection by examining the morphology of the sacral hiatus by ultrasonography.
详细描述
The study was designed as prospective, randomized, controlled trial. The patients who meet the eligibility requirements will be randomized into two groups in a 1:1 ratio to fluoroscopy and ultrasound+fluoroscopy. Before the procedure, all patients will be scanned with ultrasonography to examine the caudal region morphology.
Processing time will be recorded during injection. "Fluoroscopy time" (sec) and "kerma-area product" (μGy) automatically measured by the fluoroscopy device will be used to evaluate the radiation exposure.
Pre-procedural visual analogue scale (VAS) scores and Oswestry Disability Index (ODI) values were noted all the patients.
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
- Single (Participant)
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
- •Aged> 18 years
- •Participation in the study voluntarily
- •Diagnosis of radiculopathy caused by spinal stenosis or disc herniation after physical examination and imaging (BT or MRI)
排除标准
- •Cauda equina syndrome or rapidly progressing neurological deficit
- •previous spine surgery
- •local site infection
- •history of allergy to local anesthetic and contrast agents
- •acute or chronic unstable medical disease
- •psychiatric illness
- •anticoagulant therapy
结局指标
主要结局
Processing Time
时间窗: during the intervention
The time will be measured by a researcher who will be present in the processing room, using a stopwatch. The chronometer will be started by the researcher with the contact of the needle tip with the skin, in which local anesthetic is used, and the time measurement will be terminated when the spinal treatment needle is withdrawn from the patient.
次要结局
- Kerma-area Product (μGy)(immediately after the intervention)
- Visual Analogue Scale(baseline, change from baseline VAS at 2 and 8 weeks after intervention)
- Oswestry Low Back Pain Disability Questionnaire(baseline, change from baseline VAS at 2 and 8 weeks after intervention)
- Fluoroscopy Time(immediately after the intervention)
研究者
Yasin Demir
Associate professor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital