School of Biomedical Sciences, Queensland University of Technology, Brisbane, Queensland, Australia.
Brain Stimulation and Rehabilitation (BrainStAR) Lab, School of Health Sciences, Western Sydney University, Penrith, New South Wales, Australia.
BMJ Open. 2024 Nov 14;14(11):e090523. doi: 10.1136/bmjopen-2024-090523.
Knee osteoarthritis (OA) represents a leading cause of disability globally. Exercise has been demonstrated to improve pain and function in people with knee OA. However, when in pain, commencement of exercise is difficult, and clinical effects with such interventions are often modest. Recently, transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, has been shown to bolster the pain-relieving effect of exercise in experimental settings. While promising, the utility of employing this approach beyond the research environment is yet to be elucidated. Therefore, this pilot study aims to investigate the feasibility, safety, adherence, tolerability and preliminary efficacy of tDCS and exercise in home-based settings to improve pain and function in people with knee OA.
This protocol is for a pilot randomised, double-blinded, sham-controlled trial. 24 individuals with idiopathic knee OA will be randomised to receive either active tDCS+exercise (Intervention) or sham tDCS+exercise (Control) at home. Participants will receive 20 min of tDCS 5 days per week for the first 2 weeks of this 8-week trial. Participants in both groups will complete a lower limb strengthening programme 3 days per week for the entire 8 weeks. Outcome measures of feasibility (acceptability, satisfaction, retention), safety, adherence and tolerability will be assessed throughout the trial period, with clinical outcomes of pain and function assessed before and following the intervention. Feasibility, safety, adherence and tolerability outcomes will be explored descriptively using frequencies and percentages. To examine preliminary efficacy, within-group and between-group changes in pain and functional measures will be analysed.
This protocol obtained ethical approval from the Queensland University of Technology Human Research Ethics Committee (HREA 2024-8302-20200). All participants will provide written informed consent. The findings of the study will be disseminated via journal publications and international conference proceedings.
ACTRN12624000397516p.
膝骨关节炎（OA）是全球范围内导致残疾的主要原因。运动已被证明可改善膝骨关节炎患者的疼痛和功能。然而，当人们感到疼痛时，开始运动是困难的，而且这种干预的临床效果往往是适度的。最近，经颅直流电刺激（tDCS）作为一种非侵入性脑刺激形式，已被证明可以增强实验环境中运动的止痛效果。虽然很有前途，但在研究环境之外使用这种方法的效用尚未阐明。因此，这项初步研究旨在调查 tDCS 和运动在家庭环境中的可行性、安全性、依从性、耐受性和初步疗效，以改善膝骨关节炎患者的疼痛和功能。
这是一项初步的随机、双盲、假对照试验的方案。将 24 名特发性膝骨关节炎患者随机分为在家接受主动 tDCS+运动（干预）或假 tDCS+运动（对照）。参与者将在 8 周试验的前 2 周内每周接受 5 天、每次 20 分钟的 tDCS。两组参与者都将在 8 周内每周完成 3 天的下肢强化方案。在整个试验期间，将评估可行性（可接受性、满意度、保留率）、安全性、依从性和耐受性的结果，并用干预前后的疼痛和功能评估临床结果。使用频率和百分比描述性地探讨可行性、安全性、依从性和耐受性结果。为了检验初步疗效，将分析疼痛和功能测量的组内和组间变化。
本方案已获得昆士兰科技大学人类研究伦理委员会（HREA 2024-8302-20200）的伦理批准。所有参与者将提供书面知情同意书。研究结果将通过期刊出版物和国际会议论文集传播。
ACTRN12624000397516p。
