Dose Dependent Response to Interlaminar Steroid Injections for Lumbar Radiculopathy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pain Intensity (Numeric Rating Scale 0-10) (NRS)
研究概览
简要总结
This study aims to evaluate the efficacy of interlaminar steroid injections at treating pain in lumbar radiculopathy at varying doses, to evaluate the efficacy of interlaminar steroid injections at improving quality of life and function in lumbar radiculopathy at varying doses, and to evaluate difference in efficacy between triamcinolone and dexamethasone interlaminar steroid injections at treating pain in lumbar radiculopathy at varying doses, with the overarching hypotheses that there is no difference in reported pain reduction, quality of life, or function among patients receiving low, moderate, or high doses, and no difference in reported pain reduction between triamcinolone and dexamethasone.
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
- •Adults able to consent
- •Lumbar radiculopathy with MRI-confirmed pathology
- •No history of back surgery
- •Use of interlaminar approach lumbar spine injections
- •No use of oral pain medication other than Tylenol or Acetaminophen during the 6 weeks after injection
排除标准
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •History of back surgery
- •Use of oral pain meds other than Tylenol or Acetaminophen during the 6 weeks after injection
研究组 & 干预措施
Triamcinolone: 10 mg Group
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 10 mg
干预措施: Triamcinolone 10 Mg/mL Injectable Suspension (Drug)
Triamcinolone: 40 mg Group
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 40 mg
干预措施: Triamcinolone 40 Mg/mL Injectable Suspension (Drug)
Triamcinolone: 80 mg Group
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 80 mg
干预措施: Triamcinolone 80 Mg/mL Injectable Suspension (Drug)
Dexamethasone: 8 mg Group
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 8 mg.
干预措施: Dexamethasone 8 MG (Drug)
Dexamethasone: 4 mg Group
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 4 mg.
干预措施: Dexamethasone 4mg (Drug)
Dexamethasone: 2 mg Group
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 2 mg.
干预措施: Dexamethasone 2 MG (Drug)
结局指标
主要结局
Pain Intensity (Numeric Rating Scale 0-10) (NRS)
时间窗: Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)]
Pain intensity will be measured using the Numeric Rating Scale (NRS), a validated 0-10 verbal rating scale in which participants rate their pain on a continuum from 0 (pain) to 10 (max pain). Higher scores indicate greater pain severity.
次要结局
- Physical Function Oswestry Disability Index (ODI)(Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks))
- Quality of Life Short Form 36 (SF-36)(Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks))
研究者
Seyed Mostoufi
Associate Processor, Physical Medicine and Rehabilitation
University of Miami