Comparison of the Therapeutic Efficacy and Safety of Ultrasound-guided Cervical Selective Nerve Root Block and Fluoroscopic Guided Cervical Transforaminal Epidural Block in Patients With Cervical Radiculopathy: A Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- The difference in pain change
研究概览
简要总结
This study retrospectively analyzed medical records and imaging records (ultrasound images, fluoroscopy-guided images) of US-CSNRB and FL-CTFEB procedures performed at the Yangsan Pusan National University Hospital Pain Clinic outpatient department from May 1, 2019, to April 30, 2024. It compared the therapeutic effects (pain reduction), procedure-related indicators (comparison of contrast agent spread), safety (incidence of complications), and changes in analgesic usage.
The primary outcome of this study is the difference in pain chage (Visual Analogue Scale, VAS) between patients undergoing US-CSNRB and FL-CTFEB. The secondary outcomes are comparison of contrast agent spread and comparison of procedure-related complication rates.
详细描述
The following information is retrospectively collected and observed for comparison based on the electronic medical records of selected patients.
- Patient characteristics: Age, height, weight, gender, lesion segment (e.g., C6/C7), comorbidities
- Procedure-related indicators:
1) Procedure method (US-CSNRB or FL-CTFEB) 2) Procedure site, procedure level, adverse events during the procedure 3) Contrast agent distribution pattern: Extent of contrast agent spread into the epidural space and into the nerve roots during the procedure 3. Treatment efficacy indicators: VAS (based on arm pain) at the first visit -baseline, the second visit - 1 month after procedure, the third visit - 2 month after procedure, and 4th visit - 3 months post-procedure; treatment success rate (VAS score reduction of 30% or more) 4. Safety indicators: Presence and type of procedure-related complications documented in medical records (e.g., intravascular injection, nerve injury, local anesthetic toxicity symptoms, transient motor paralysis, etc.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Adult male and female patients aged 18 years or older.
- •Patients diagnosed with cervical radiculopathy who underwent US-guided or FL-guided procedures.
- •Patients with clearly documented pain scale (VAS) assessments in medical records at the following time points: 1st visit (before the procedure), 2nd visit, 3rd visit, and at least 3 months post-procedure.
- •Patients who underwent procedures for lesions in a single or adjacent two segments.
排除标准
- •Patients who underwent surgical treatment within one month after the procedure due to progressive neurological deficits.
- •Patients with severe systemic diseases (e.g., cancer, severe immunosuppressive disorders) that may affect pain assessment.
- •Patients with severe systemic diseases (e.g., cancer, severe immunosuppressive disorders) that may affect pain assessment.
研究组 & 干预措施
group U
干预措施: ultrasound guided cervical selective nerve root block (Procedure)
group F
干预措施: fluoroscopy-guided cervical transforaminal epidural block (Procedure)
结局指标
主要结局
The difference in pain change
时间窗: baseline, 1 month, 2 month, 3 month
the difference in pain change, assessed using the visual analogue scale (VAS), between patients who underwent US-CSNRB and those who underwent FL-CTFEB
次要结局
- The pattern of contrast spread(periprocedural)
- The incidence of procedure-related complications(Periprocedural)
研究者
Gyeong-Jo Byeon, MD, PhD
Associate Professor
Pusan National University Yangsan Hospital