NCT01079026已完成不适用
Functional Outcome After Lumbar Epidural Steroid Injection
Scuderi, Gaetano J., M.D.0 个研究点目标入组 26 人开始时间: 2008年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 主要终点
- functional outcome on SF-36 following ESI
研究概览
简要总结
prospectively validate a fibronectin-aggrecan complex as a biomarker for response to ESI for radiculopathy with HNP
详细描述
We will measure levels of the protein complex in the epidural space of patients undergoing lumbar ESI for radiculopathy with HNP. We assess functional outcomes at baseline and after treatment with the Medical Outcomes Study Short Form-36 instrument (SF-36). Our hypothesis was that the complex is present in patients with clinically significant functional improvement after ESI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute onset of sensory symptoms with the primary complaint as pain as well as varying sensory symptoms (e.g. tingling, numbness) in one or more lumbar nerve root distributions
- •Positive physical exam findings including sensory findings consistent with a spinal nerve root, a positive straight leg raise test, and/or a diminished patellar or Achilles DTR consistent with sensory symptoms; AND
- •MRI of lumbar spine positive for HNP in a distribution correlating with physical examination
排除标准
- •Plain radiography demonstrating severe loss of disc height, high grade DDD, spondylolisthesis greater than grade I
- •A history of prior lumbar surgery or trauma, weakness in a consistent distribution (non-progressive with strength at least 4/5)
- •Red flags including progressive weakness, bowel/bladder complaints, radiographic unknown mass, unexpected weight loss; AND
- •Diagnosis of inflammatory arthritides, crystalline arthropathies, or other rheumatologic diseases
结局指标
主要结局
functional outcome on SF-36 following ESI
时间窗: 2-6 weeks
次要结局
未报告次要终点
研究者
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