EUCTR2013-004505-14-NO进行中（未招募）1 期
Antibiotic treatment in patients with chronic low back pain and Modic Changes: a double-blind randomized placebo-controlled trial
Oslo University Hospital HF, Ullevål Hospital, FORMI-Formidlingsenheten for muskel- og skjelettlidelser0 个研究点目标入组 280 人开始时间: 2016年8月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria will be as follows:
- •Age between 18 and 65 years
- •LBP of > 6 months duration in the area from L1 to L5 with a Numerical Rating Scale (NRS) score of ? 5 (mean of three NRS scales; current LBP, the worst LBP within the last 2 weeks, and usual/mean LBP within the last 2 weeks).
- •MRI-confirmed disc herniation within the preceding 2 years or degenerated disc (Pfirrmann grade ? 348) at level L3/L4, L4/L5 or L5/S1.
- •MC type I or type II adjacent to a previously herniated disc or adjacent to a degenerated disc (Pfirrmann grade ? 348), based on T1- and T2 weighted MRI.
- •Both conservative and surgically treated patients will be included.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 280
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Allergy to antibiotics or gradolinium contrast
- •Current pregnancy or lactation
- •Any kidney disease or pending litigation
- •Any specific LBP diagnosis that may explain patients symptoms.
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