A Pilot Randomized Trial of Scrambler Therapy or Sham Treatment for Persistent Nonspecific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Worst Low Back Pain Score
研究概览
简要总结
This pilot study will evaluate Scrambler therapy and Sham treatment on levels of low back pain, pain sensitivity and mRNA expression of pain sensitivity candidate genes.
详细描述
This pilot study will evaluate the feasibility of the experimental protocol and provide sufficient pilot data to estimate statistical power and sample size requirements. The study will include 30 individuals (15 per group) diagnosed with persistent low back pain who will receive a standard protocol of Scrambler therapy or sham treatment. Participant data will include subjective measures of low back pain, pain sensitivity using quantitative sensory testing, and mRNA expression levels of pain sensitivity candidate genes at baseline (prior to treatment) and 1 and 3 weeks post-treatment.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be 18-50 years of age
- •diagnosed with persistent nonspecific LBP
- •comprehend English
排除标准
- •<18 or >50 years of age
- •chronic pain at another site or associated with a painful condition
- •pregnant or within 3 months post-partum
- •implanted drug delivery system
- •heart stents or metal implants such as pacemakers, automatic defibrillator, aneurysm clips, vena cave slips, or skull plates
- •history of myocardial infarction or ischemic heart disease within the past six months
- •history of epilepsy
- •skin conditions such as open sores that would prevent proper application of electrodes
结局指标
主要结局
Worst Low Back Pain Score
时间窗: baseline to 3 weeks post-treatment
Low back pain will be measured by the Brief Pain Inventory (BPI). The BPI assesses the severity of pain, location of pain, pain medications, amount of pain relief in the past 24 hours and the past week, and the impact of pain on daily functions. For this study, the worst pain score will be used in the analysis. The worst pain score is rated from "0" meaning no pain to "10" meaning pain as bad as you can imagine.
次要结局
未报告次要终点