NSAIDs in Sciatica (NIS), an Investigator Initiated Randomised Placebo Controlled Trial of Naproxen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 4
- 主要终点
- Leg pain
研究概览
简要总结
This study will evaluate whether treatment with Naproxen 500 mg twice daily is superior to placebo for the improvement of leg pain in patients with sciatica. Half of patients will receive Naproxen while the other half will receive placebo.
详细描述
Sciatica is an established term for pain radiating from the lower back or buttock into the leg, commonly caused by a disc herniation. Given their analgesic and anti-inflammatory mechanisms of action, NSAIDs (Non-steroidal anti-inflammatory drugs) have been, and are still being regarded as standard therapy for sciatica.
However, very few randomised controlled trials of NSAIDs have been undertaken in sciatica, and no study has showed clinically meaningful effects as compared to placebo.
Since NSAIDs involve the risk of serious gastrointestinal, vascular and renal side effects there is a strong need to clarify their potential beneficial effects in sciatica.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo 1 tablet twice daily
干预措施: Placebo (Drug)
Naproxen
Naproxen 500 mg twice daily
干预措施: Naproxen 500 Mg (Drug)
结局指标
主要结局
Leg pain
时间窗: Daily from baseline to day10
A 0-10 numeric rating scale of average leg pain intensity in the previous 24 hours
次要结局
- Back pain(Daily from baseline to day10)
- Sciatica symptoms(Day 0, day 5, day, day 10, day 12)
- Disability(Day 0, day 5, day, day 10, day 12)
- Work(Day 0, day 10, day 12)
- Improvement(Day 5, day 10)
- Opioid medication(Daily from day1 to day10)
- Rescue medication(Daily from day1 to day10)
- Responder(Day 5, day 10)