Evaluation of Efficacy and Safety of Epidural Steroid Injection Using Dexamethasone or Betamethasone in Patients With Spinal Pain: a Prospective, Randomized, Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- the proportion of patients with pain improvement
研究概览
简要总结
Particle steroid drug such as triamcinolone has been used widely for epidural steroid injection (ESI) treatment in Korea. However, Korea FDA recently prohibit ESI using triamcinolone, following the regulation of US FDA. Therefore, dexamethasone and betamethasone become only candidate drugs for ESI in Korea and the investigators are curious about the effectiveness and safety of both drugs due to limitation of information about comparison of two drugs in previous literature. So, this study aims to compare the effectiveness and safety of both drugs and our hypothesis is that there is no difference of the effectiveness between dexamethasone and betamethasone at 2 weeks after ESI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with spinal pain (i.e.neck pain, back pain, or radiculopathy..)
- •patients with informed consent
- •visual analog scale (VAS) is five or more in 10-point scale at screening
- •sustained spinal pain, regardless of sufficient conservative treatment (i.e. oral medicine, physical therapy..)
排除标准
- •age of patient less than 19 years
- •relative contraindication of epidural steroid injection, as follows:
- •pregnant or breast-feeding state
- •uncontrolled coagulopathy
- •suspected of active infection state
- •uncontrolled diabetes mellitus
- •previous history of adverse event related to epidural steroid injection
研究组 & 干预措施
ESI-1
epidural steroid injection using dexamethasone
干预措施: Dexamethasone (Drug)
ESI-2
epidural steroid injection using betamethasone
干预措施: Betamethasone (Drug)
结局指标
主要结局
the proportion of patients with pain improvement
时间窗: baseline and 2 weeks
the proportion of patients with significant pain improvement at 2 week after epidural steroid injection, with the patients' subjective satisfaction scale of "much improved" or "no pain"
次要结局
- incidence of adverse events(during 12 weeks after epidural steroid injection)
- disability improvement(baseline and 2 weeks)
- pain relief(baseline and 2 weeks)
研究者
Joon Woo Lee
Associate professor, Department of Radiology
Seoul National University Bundang Hospital