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 人开始时间: 2024年9月17日最近更新: 2024年9月30日

适应症

试验速览

阶段: Unknown
状态: 进行中（未招募）
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

暂无简介。

•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

•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

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

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)

发起方