Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester, Glenfield Hospital, Leicester, UK
Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester, Glenfield Hospital, Leicester, UK.
BMJ Open. 2022 Aug 25;12(8):e061113. doi: 10.1136/bmjopen-2022-061113.
Knee osteoarthritis (KOA) is a leading cause of disability and is characterised by degenerative changes causing pain and loss of function. Neuromuscular electrical stimulation (NMES) has been shown to influence muscle size and strength in healthy subjects. A novel self-administered NMES device has been developed to help manage the symptoms of KOA. This study aims to investigate the effects of combining NMES of the calf and quadriceps on individuals with KOA.
193 individuals with KOA will be recruited to a single-centre, double-blind, randomised, sham-controlled trial at the Respiratory Biomedical Research Centre, Leicester, UK. Participants will be randomised (1:1) to follow an 8-week home-based intervention using a NMES device or sham device. The NMES device consists of footplate electrodes and two quadriceps electrodes. Footplate stimulation will be completed daily for 30 min and quadriceps stimulation for 20 min, five times a week (compliance is recorded in a self-reported participant diary). The primary outcome is the Western Ontario and McMaster Universities Arthritis Index pain domain, taken at 8 weeks follow-up. Secondary outcomes will explore quadriceps muscle strength, swelling, health-related quality of life, exercise capacity, anxiety and depression, sleep, physical activity and self-reported compliance. A powered subgroup analysis for compliance to the active device will be complete for the primary outcome. Participant focus groups will be completed following recruitment of half of the participants and after all participants have been recruited.
Ethical approval has been obtained from the North-West Preston ethics committee (17/NW/0081). Participants are required to provide informed consent following review of the participant information sheet and discussion regarding study procedures with a member of the research team. The study results will be disseminated to the appropriate stakeholders through presentations, conferences and peer-reviewed journals. Results will be presented to participants following study completion at the Biomedical Research Centre-Respiratory, Glenfield Hospital, Leicester.
ISRCTN registry, ISRCTN12112819 (date registered 1 May 2019). IRAS registry 219 693. University Hospitals of Leicester registry 91 017. Protocol Version 8.
膝骨关节炎（KOA）是导致残疾的主要原因，其特征是退行性变化导致疼痛和功能丧失。神经肌肉电刺激（NMES）已被证明可影响健康受试者的肌肉大小和力量。一种新的自我管理 NMES 设备已被开发出来，以帮助管理 KOA 的症状。本研究旨在探讨小牛和四头肌 NMES 联合应用于 KOA 患者的效果。
193 名 KOA 患者将在英国莱斯特的呼吸生物医学研究中心参加一项单中心、双盲、随机、假对照试验。参与者将按照 1:1 的比例随机分为接受 8 周家庭 NMES 设备或假设备干预组。NMES 设备包括足底电极和两个股四头肌电极。足底刺激每天完成 30 分钟，股四头肌刺激每周 5 次，每次 20 分钟（依从性记录在自我报告的参与者日记中）。主要结局是 8 周随访时的西部安大略省和麦克马斯特大学关节炎指数疼痛域。次要结局将探索股四头肌肌肉力量、肿胀、健康相关生活质量、运动能力、焦虑和抑郁、睡眠、身体活动和自我报告的依从性。对于主要结局，将对符合主动设备的依从性进行分组分析。在招募一半参与者后和所有参与者招募完成后，将完成参与者焦点小组。
已获得西北普雷斯顿伦理委员会（17/NW/0081）的批准。参与者需要在审查参与者信息表并与研究团队成员讨论研究程序后，提供知情同意。研究结果将通过演讲、会议和同行评议期刊向适当的利益相关者传播。研究完成后，将在莱斯特格伦菲尔德医院的生物医学研究中心-呼吸科向参与者报告结果。
ISRCTN 注册处，ISRCTN12112819（注册日期 2019 年 5 月 1 日）。IRAS 登记号 219693。莱斯特大学医院登记号 91017。方案版本 8。
