Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Radicular Pain Visual Analogue Scale (VAS) Score change from baseline
研究概览
简要总结
The aim of this study is to assess the effectiveness and safety of dexamethasone for transforaminal epidural steroid injection. A secondary aim of this study is to obtain data on the lowest most effective dose of dexamethasone for this treatment and the effective duration of effect.
详细描述
Transforaminal epidural steroid injections (TFESI) have been demonstrated to be an effective treatment for radicular pain. Over the last decade, rare but serious complications have been reported following transforaminal epidural steroid injections (TFESI). Recent research indicates that certain types of corticosteroids containing microscopic particles may be responsible for these adverse events. Dexamethasone (DXM) is a non-particulate cortico-steroid that has not been implicated in these adverse events. However, there is inadequate evidence up to date to support the use of Dexamethasone (DXM) for transforaminal epidural steroid injections (TFESI). This study aims to bridge that gap.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •adults age 18 years and older, unilateral lumbar radicular pain, baseline distal radicular lower extremity pain VAS score ≥ 5/10, and prior favorable response to TFESI
排除标准
- •pregnancy, infection, coagulopathy, uncontrolled diabetes mellitus, history of allergy to iodinated contrast medium and interventional therapies for pain within 90 days prior to study enrollment
结局指标
主要结局
Radicular Pain Visual Analogue Scale (VAS) Score change from baseline
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks post injection
Reduction of pain from baseline at each time point.
次要结局
- Oswestry Disability Index (ODI)- change from baseline(Baseline, 4 weeks, 8 weeks, 12 weeks post injection)
- Subject Global Impression of Change (SGIC)(4 weeks, 8 weeks, 12 weeks)
- Subject Global Satisfaction Scale (SGSS)(4 weeks, 8 weeks, 12 weeks post injection)
- Number of Subjects with Adverse Events as a Measure of Safety and Tolerability(Day of and 1 week post injection)