NCT01816334已完成4 期
Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Mean visual analogue scale (VAS) for leg pain (radicular pain) in 3 groups
研究概览
简要总结
The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids are effective in the treatment of acute 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •sciatica <8 weeks resistant to all treatments in ambulatory
- •Acute low back pain> 48 hours;
- •Non-deficit patients;
- •Initial VAS> 40/100;
- •Consent of patient
- •Conflict disco-radicular concordance with the clinical computed tomography scan or magnetic resonance imaging.
- •No of contraindications to methylprednisolone, ketoprofen;
- •No registration to another protocol;
排除标准
- •Pregnant, parturient, lactating mother;
- •Diabetic patient;
- •Patient with syndrome from narrowing of the lumbar vertebral canal
- •Patient with a history of lumbar surgery <1 year;
- •Patient with a Cauda equina syndrome or major motor disability;
- •Crural neuralgia
- •Patient with a deficit;
- •Suspicion of sciatica secondary, ie not conflict-related disco-root: infectious neuritis, fracture on spinal bone tumor ...
- •associated treatment or pathology contra-indicating administration methylprednisolone, ketoprofen.
研究组 & 干预措施
methylprednisolone
Active Comparator
administration of 60 mg of methylprednisolone at 8:00 am and 100 ml of 0.9 % sodium chloride (placebo) at 6:00 pm
干预措施: methylprednisolone (Drug)
methylprednisolone
Active Comparator
administration of 60 mg of methylprednisolone at 8:00 am and 100 ml of 0.9 % sodium chloride (placebo) at 6:00 pm
干预措施: Sodium Chloride (Drug)
Ketoprofen
Active Comparator
administration of 100 mg of ketoprofen at 8:00 am and at 6:00 pm
干预措施: Ketoprofen (Drug)
sodium chloride
Placebo Comparator
administration of 100 ml of 0.9% sodium chloride (placebo) at 8:00 am and at 6:00 pm
干预措施: Sodium Chloride (Drug)
结局指标
主要结局
Mean visual analogue scale (VAS) for leg pain (radicular pain) in 3 groups
时间窗: From day 0 to day 5
VAS is measured in millimiters (0 to 100). This pain score is recommended in rheumatologic units in France.
次要结局
- Mean visual analogue scale (VAS) for back pain in 3 groups(From day 0 to day 5)
- Assess drug compliance(From day 0 to day 5)
- The effect of treatment on the EIFEL Questionnaire(At baseline, 1 and 3 months after intervention)
- Improvement in Lasegue's sign compared to baseline(At baseline, Day 1,2,3,4 and 5 of study period)
- Assess Schober's test(From Day 0 to Day 5)
- Analgesic consumption(At baseline, day 0, 1, 2, 3, 4 and day 5, 1 and 3 months)
- Surgery or lumbar epidural injection(At 1 and 3 months after intervention)
- Clinical tolerance: adverse events and/or high blood pressure(at baseline, day 1, 2 3, 4 and 5)
- Biological tolerance(at baseline, day 3 and 5)
- Glycemic levels(at baseline, day 1 to 5)
- Number of days of hospitalisation sick leave, number of days lost to illness(At baseline, 1 and 3 months)
研究者
研究点 (2)
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