NCT00533286已完成2 期
Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse: a Prospective Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 主要终点
- (i) median extent of reduction of referred pain
研究概览
简要总结
Sixty patients were randomized to receive either placebo or diazepam in addition to mechanical physiotherapy and analgesics for the first 7 days of conservative treatment of clinically and radiologically confirmed lumbar disk prolapse
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sciatica without or with neurological deficit attributable to lumbar disc prolapse
- •CT or MRI confirmation of lumbar disc prolapse
- •informed consent
排除标准
- •bladder or bowel disturbance
- •acute (< 24 h) development of paresis grade 1 or plegia
- •taken benzodiazepines for more than 2 weeks
- •history of benzodiazepine intolerance
- •prior surgery for disc prolapse, or prior trauma to the vertrebral column
研究组 & 干预措施
A
Placebo Comparator
placebo (2 tablets daily)
干预措施: benzodiacepine (Drug)
B
Experimental
diazepam (2 x 5 mg)
干预措施: benzodiacepine (Drug)
结局指标
主要结局
(i) median extent of reduction of referred pain
时间窗: 7 days
次要结局
- median duration of inability to work after discharge(one year)
研究者
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