Effectiveness of Microcurrent in the Treatment of Chronic Tennis Elbow - a Preliminary Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Tendon pathology as indicated by sonography
研究概览
简要总结
Tennis elbow is a relatively common musculoskeletal disorder that can cause significant pain and disability. Treatment of the disorder is not always successful, and it often recurs or becomes chronic. More effective management options are required. There is evidence that electric microcurrent can promote tissue healing and symptom resolution in various chronic hard and soft tissue disorders, but few human studies investigating its use with chronic tendon problems. It is an easily applied therapy with very few reports of side effects. It can be applied at home using a portable unit and, if it is clinically effective, may also prove more cost effective than other therapies.
A clinical trial is planned to evaluate the therapy but, in the absence of relevant published evidence, a preliminary study is required to look for a treatment effect and inform a power calculation for sample size, The study will also allow some investigation of dose-dependence, which is a key issue in many forms of electrotherapy. Finally it will enable evaluation of elements of the full trial protocol so that any weaknesses can be addressed before it begins.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptoms of tennis elbow for at least 3 months
- •clinical diagnosis of tennis elbow
排除标准
- •significant symptom improvement in previous month
- •receipt of any active treatment for the condition in the previous month
- •currently under the care of another health professional for tennis elbow
- •current cervical radiculopathy
- •other pathology affecting distal upper limb
结局指标
主要结局
Tendon pathology as indicated by sonography
时间窗: baseline, 3 weeks, 6 weeks, 4 months
Patient-Rated Global Change Score
时间窗: 3 weeks, 6 weeks, 4 months
次要结局
- Pain Free Grip Strength(baseline, 3 weeks, 6 weeks, 4 months)
- Adverse events(3 weeks, 6 weeks, 4 months)
- Patient-rated Tennis Elbow Questionnaire(baseline, 3 weeks, 6 weeks, 4 months)
- Patient-Specific Functional Scale(baseline, 3 weeks, 6 weeks, 4 months)
