NCT02615418Unknown不适用
A Novel Non Invasive Brain Stimulation,tDCS Based Treatment for Chronic Low Back Pain (CLBP)-Sourasky Medical Center-Tel Aviv
NIBS NeuroScience Technologies0 个研究点目标入组 60 人开始时间: 2016年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS)
研究概览
简要总结
This trial is designed to preliminary evaluate the efficacy and safety of NIBS system for treatment of chronic low back pain (CLBP) (over 6 months). The trial is of a double blind sham controlled partial crossover design and will involve 2 weekly treatments and evaluations for 6 weeks, with 6 weeks follow-up. The goal of the study is to 1. Asses the CLBP change immediate and long term effect for the trial duration and follow-up. 2. Asses quality of life improvement as measure by sleep quality and questioners. 3. Asses long term neuronal changes or lack thereof in treated and untreated subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80
- •CLBP as defined by the European guidelines.
- •low back pain first week average NPRS>4.
排除标准
- •Acute low back pain (duration of less than 6 months) first week average NPRS> 4
- •Neurological illness causing structural brain damage (e.g. Stroke, TIA)
- •Psychiatric disease other than mood disorders
- •Current chronic use of medications with pro-epileptic properties
- •Known alcohol dependency
- •Use of alcohol within the previous 24 hours
- •History of loss of consciousness
- •Epilepsy or epilepsy in a first degree relative
- •Medical implants
- •Illicit drug use or within the previous month
结局指标
主要结局
Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS)
时间窗: Baseline to week 6 .
次要结局
- Change From Baseline in Sleep Quality (0-10 Numerical Rating Scale Scores)(Baseline to 6 weeks)
- Change CLBP quality of life -Roland-Morris questionnaire(Baseline to 6 weeks)
研究者
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