Antibiotic Treatment to Patients With Low Back Pain Associated With Modic Changes Following Disc Herniation. A Randomized Clinical Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Low Back Pain Roland Morris Questionaire
研究概览
简要总结
A large proportion of patients with Low Back Pain (LBP) (80 %) are classified as "non-specific", due to the lack of a patho-anatomical diagnosis. This term is not satisfactory, since it implies uncertainty for both the patient and the clinician. Modic changes have recently been identified as a pain giving patho-anatomical diagnosis for a considerable percentage (20-30 %) of LBP patients. The causes of these Modic changes have not been determined conclusively but bacterial infection is among the plausible causes for those following a disc herniation.
Purpose The aim of this study is to assess the clinical effect of antibiotic treatment compared to placebo, in patients with LBP and Modic changes following a lumbar herniated disc.
Design A double blind prospective clinically controlled trial. Patients will be randomized by a blinded observer to either Group A: 1 antibiotic tablet 45 patients Group B: 1 placebo tablet 36 patients Group C: 2 antibiotic tablets 45 patients Group D: 2 placebo tablets 36 patients
The patients will take the drug three times a day for 100 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-65 years
- •Previous lumbar herniated disc confirmed by MRI
- •Time since lumbar disc herniation more than 6 months less than 2 years
- •LBP in the area of L1 to L5, with an added Low Back Pain Rating Scale of 6 or more
- •The present MRI shows Modic changes
- •Positive Springing test (SPT) at the level of Modic changes
排除标准
- •Allergy against antibiotics
- •The Beck Depression Inventory >7,
- •Pregnancy
- •Breast feeding
- •All Kidney diseases
- •Pending workers litigation or pension
- •Danish as second language
- •Fertile women who do not user safe anti conseption
- •Reduced liver functions
- •Reduced liver function due to previous treatment wiht amoxicillin/clavulanasid.
研究组 & 干预措施
Group A, Antibiotic
1 antibiotic tablet 45 patients Group
干预措施: Bioclavid (Drug)
Group B: 1 placebo
1 placebo tablet
干预措施: Placebo (Drug)
Group C: Antibiotics
2 antibiotic tablets 45 patients
干预措施: Bioclavid (Drug)
Group D, Placebo
2 placebo tablets 36 patients
干预措施: Placebo (Drug)
结局指标
主要结局
Low Back Pain Roland Morris Questionaire
时间窗: One year follow-up
次要结局
未报告次要终点