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临床试验/NCT00601497
NCT00601497已完成不适用

Effects of Electrical Stimulation on Osteoarthritis of the Knee

University of Virginia2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2004年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
2
主要终点
Knee Pain

研究概览

简要总结

The purpose of this study is to find out whether electrical stimulation can reduce knee pain and increase function in people with osteoarthritis of the knee.

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
Single (Participant)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 50 years of age or older
  • Diagnosis of primary osteoarthritis of the knee (as defined by American College of Rheumatology criteria)
  • Knee pain of at least six months duration
  • Moderate or greater knee pain (defined as a score of 3 or greater on an 11 point numeric pain rating scale) for most days in the last month
  • Willing to abide by protocol and treatment schedule.

排除标准

  • Implants, such as pacemaker, TENS, or insulin pump, incompatible with electrical stimulation
  • Uncontrolled concomitant disease affecting the knee, such as: rheumatoid arthritis, systemic lupus erythema, psoriatic arthritis
  • Pregnant or breast-feeding
  • Intra-articular corticosteroid or hyaluronic acid injection into the knee within 3 months preceding study
  • Arthroscopy of the knee within the past year
  • Significant injury to the knee within the past 6 months
  • Use of assistive devices other than a cane or knee brace
  • Disease of spine or other lower extremity joints of sufficient degree to affect assessment of the knee

结局指标

主要结局

Knee Pain

时间窗: Baseline, Week 4, Week 8, and Week 12

次要结局

  • Knee function(Baseline, Week 4, Week 8, and Week 12)
  • Knee stiffness(Baseline, Week 4, Week 8, and Week 12)
  • Patient global assessment(Baseline, Week 4, Week 8, and Week 12)
  • Health-related quality of life(Baseline, Week 4, Week 8, and Week 12)

研究者

申办方类型
Other

研究点 (2)

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