跳至主要内容
临床试验/NCT00817232
NCT00817232已完成2 期

Effectiveness of Microcurrent in the Treatment of Chronic Tennis Elbow - a Preliminary Trial

University of Hertfordshire2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2008年12月1日最近更新:
适应症

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

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)

研究者

发起方
University of Hertfordshire
申办方类型
Other

研究点 (2)

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