Chang Wei-Ju, Adie Sam, Naylor Justine M, Chowdhury Nahian, Finn Harrison, Rizzo Rodrigo R N, O'Hagan Edel, Schabrun Siobhan M
Centre for Pain IMPACT, Neuroscience Research Australia, Randwick, New South Wales, Australia
School of Health Sciences, The University of Newcastle, Callaghan, New South Wales, Australia.
BMJ Open. 2022 Aug 5;12(8):e062577. doi: 10.1136/bmjopen-2022-062577.
INTRODUCTION: Knee osteoarthritis is a leading cause of disability, resulting in pain and reduced quality of life. Exercise is the cornerstone of conservative management but effects are, at best, moderate. Early evidence suggests that repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex (M1) may improve the effect of exercise in knee osteoarthritis. This pilot study aims to (1) determine the feasibility, safety and participant-rated response to an intervention adding M1 rTMS to exercise in knee osteoarthritis; (2) elucidate physiological mechanisms in response to the intervention; (3) provide data to conduct a sample size calculation for a fully powered trial. METHODS AND ANALYSIS: This is a pilot randomised, assessor-blind, therapist-blind and participant-blind, sham-controlled trial. Thirty individuals with painful knee osteoarthritis will be recruited and randomly allocated to receive either: (1) active rTMS+exercise or (2) sham rTMS+exercise intervention. Participants will receive 15 min of either active or sham rTMS immediately prior to 30 min of supervised muscle strengthening exercise (2×/week, 6 weeks) and complete unsupervised home exercises. Outcome measures of feasibility, safety, pain, function and physiological mechanisms will be assessed before and/or after the intervention. Feasibility and safety will be analysed using descriptive analysis. Within-group and between-group comparisons of pain and function will be conducted to examine trends of efficacy. ETHICS AND DISSEMINATION: This study has been approved by the University of New South Wales Human Research Ethics Committee (HC210954). All participants will provide written informed consent. The study results will be submitted for peer-reviewed publication. TRIAL REGISTRATION NUMBER: ACTRN12621001712897p.
引言:膝关节骨关节炎是导致残疾的主要原因,会引起疼痛并降低生活质量。运动是保守治疗的基石,但其效果充其量只是中等。早期证据表明,在初级运动皮层(M1)上施加重复经颅磁刺激(rTMS)可能会改善膝关节骨关节炎运动治疗的效果。这项初步研究旨在:(1)确定在膝关节骨关节炎患者中,在运动治疗基础上增加M1 rTMS干预的可行性、安全性以及参与者自评的反应;(2)阐明对该干预措施产生反应的生理机制;(3)为进行一项有充分效力的试验计算样本量提供数据。 方法与分析:这是一项初步的随机、评估者盲法、治疗师盲法和参与者盲法、假刺激对照试验。将招募30名患有疼痛性膝关节骨关节炎的个体,并随机分配接受以下两种治疗:(1)主动rTMS + 运动治疗,或(2)假rTMS + 运动治疗干预。参与者将在30分钟的监督下进行肌肉强化运动(每周2次,共6周)之前立即接受15分钟的主动或假rTMS,并完成无监督的家庭锻炼。在干预前和/或干预后,将评估可行性、安全性、疼痛、功能和生理机制等结果指标。将使用描述性分析来分析可行性和安全性。将进行组内和组间的疼痛与功能比较,以检查疗效趋势。 伦理与传播:本研究已获得新南威尔士大学人类研究伦理委员会(HC210954)的批准。所有参与者都将提供书面知情同意书。研究结果将提交发表以供同行评审。 试验注册号:ACTRN12621001712897p
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