A Randomized Trial of CT-guided Perineural Injection With a Corticosteroid Plus a Long Acting Local Anesthetic Versus Standard Medical Management in Patients With Acute Lumbar Radiculopathy and a Corresponding Disc Herniation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire
研究概览
简要总结
Herniated disc sometimes cause back pain radiating down to a leg. This pain can be so severe that it is functionally disabling. The purpose of this randomized clinical trial is to determine if corticosteroid medication, delivered directly to the area near the herniated disc, can improve the pain and functional disability associated with a herniated disc.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults <60y
- •< 1m of symptoms
- •Symptoms consistent with herniated disc
- •MRI demonstrates corresponding disc
- •Back pain resulting in functional disability
排除标准
- •Chronic pain
- •Daily pain medication
- •Frequent back pain
- •On the job injury
研究组 & 干预措施
Standard medical care
干预措施: Standard medical care (Drug)
CT-guided intervention
CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care
干预措施: CT-guided corticosteroid+ bupivicaine (Drug)
结局指标
主要结局
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire
时间窗: Baseline and one week after emergency department discharge
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians.
次要结局
- Adverse Events(1 week after discharge from emergency department)
- Functional Disability Assessed Using Roland-Morris Scale(1 month)
研究者
Benjamin W. Friedman, MD
Prof. Emergency Medicine
Montefiore Medical Center