Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam: a Randomized, Double Blind, Placebo Controlled Cross-over Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline NRS pain scale score at different consecutive follow up assessments
研究概览
简要总结
This randomized, double-blind, placebo control, cross-over study tested the hypothesis that periradicular injections of Meloxicam would reduce recent onset low back pain and improve physical activity compared to saline injection at 3 months follow-up evaluation
详细描述
In the present study we use a well-known non steroidal anti-inflammatory drug, meloxicam, in a novel way, an IM administration near a nerve root.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •low back pain from 6 months or less
- •older than 18 years
排除标准
- •not able to understand and sign the written informed consent
研究组 & 干预措施
C-group
patients receiving an IM saline injection near the nerve root (periradicular)
干预措施: saline (Other)
M-group
patients receiving an IM Meloxicam injection near the nerve root (periradicular)
干预措施: Meloxicam (Drug)
结局指标
主要结局
Change from baseline NRS pain scale score at different consecutive follow up assessments
时间窗: 5 minutes, 1, 6, 12 and 24 hours, 1, 5, 15, 30 and 90 days
Patients reported a numeric value to evaluate pain (0= no pain, 10= wrost pain)
次要结局
- Change from baseline level of physical activities and life quality at different consecutive follow up yes/no questionnaire(5 minutes, 1, 6,12 and 24 hours, 1, 5, 15, 30 and 90 days)