Midline vs Lateral Parasagittal Approach During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection: the Role of Concordant Pressure Paresthesia in Determing Outcome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Changes in Pain Scores from baseline after Lumbar Epidural Steroid Injection
研究概览
简要总结
The purpose of this study is to compare two different approaches (midline and parasagittal) during interlaminar lumbar epidural steroid injection (LESI), and to verify the role of concordant pressure paresthesia occurring during the LESI in determining outcome.
The investigators are planning to include 100 patients, undergoing LESI for radicular low back pain. This will be single-blinded randomized study. Every patient will receive the same medication we would use regardless of participating in the study. The patients will be randomly assigned to one of two groups, based on the approach:
- Group I (50 patients) - will get LESI using midline (MIL) approach.
- Group II (50 patients) - will get LESI using parasagittal interlaminar (PIL) approach.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18- 80 years old
- •History of low back pain and unilateral lumbosacral radiculopathy pain
- •Lumbar disk disease including disk herniations, bulging discs, and degenerated discs, where at least 50% of the disk height is preserved respective to contiguous levels
排除标准
- •Discogenic pain without radiculopathy pain
- •History of previous spinal surgery
- •LESI(s) in the past year
- •Allergy to methylprednisolone, or lidocaine, or iodine-based contrast
- •Concurrent use of systemic steroid medications
- •Opioid habituation
- •Pregnancy
结局指标
主要结局
Changes in Pain Scores from baseline after Lumbar Epidural Steroid Injection
时间窗: Days 1, 7, 14, 21, 28, 60, 120, 180, 360
Pressure Paresthesia during injection
时间窗: 1 day (During Lumbar Epidural Steroid Injection)
Quality of life improvement change after Lumbar Epidural Steroid Injection
时间窗: Days 1, 7, 14, 21, 28, 60, 120, 180, 360
次要结局
未报告次要终点
研究者
Kenneth D Candido
Chairman of Anesthesia Department; Advocate Illinois Masonic Medical Center
Chicago Anesthesia Pain Specialists