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临床试验/ISRCTN94599670
ISRCTN94599670
进行中(未招募)
未知

Efficacy of electronic textile based transcutaneous nerve stimulation (TENS) in patients with knee pain due to osteoarthritis: a pilot randomised controlled trial

University Hospital Southampton NHS Foundation Trust0 个研究点目标入组 80 人2024年9月17日

概览

阶段
未知
干预措施
未指定
疾病 / 适应症
Knee osteoarthritis
发起方
University Hospital Southampton NHS Foundation Trust
入组人数
80
主要终点
Pain measured using a Visual Analogue Scale (VAS) at baseline, 1 week, 4 weeks, 8 weeks, 12 weeks
状态
进行中(未招募)
最后更新
去年

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2024年9月17日
结束日期
2025年9月30日
最后更新
去年
研究类型
Interventional
性别
All

研究者

入排标准

入选标准

  • Adults between 45 and 70 years of age
  • Diagnosed with knee OA according to American College of Rheumatology criteria
  • Pain score ranging from 3 to 7 on the Visual Analog Scale (VAS)
  • Participants will not have prior experience with TENS or other electrotherapy (e.g. interferential therapy)
  • Able to stand up unaided
  • Willing and able to give informed consent

排除标准

  • Prior major knee surgery (i.e. partial or total knee arthroplasty)
  • Anticipated surgery during the study (no anticipated surgery during the 12 weeks of the study)
  • Skin sensitivities and sensation problems
  • Uncontrolled epilepsy
  • Those who are pregnant; planning to become pregnant or are breastfeeding
  • An active device implant (e.g. pacemaker user)
  • A stent in the lower limb

结局指标

主要结局

Pain measured using a Visual Analogue Scale (VAS) at baseline, 1 week, 4 weeks, 8 weeks, 12 weeks

次要结局

  • The following secondary outcome measures will be assessed at baseline, 1 week, 4 weeks, 8 weeks, 12 weeks 1. Patient-reported pain, joint stiffness and physical function measured using the VAS, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the Oxford Knee Score (OKS)2. Health-related quality of life measured using the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

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