Ouellette Adam Louis, Liston Matthew B, Chang Wei-Ju, Walton David M, Wand Benedict Martin, Schabrun Siobhan M
Brain Rehabilitation and Neuroplasticity Unit, School of Science and Health, Western Sydney University, Penrith, New South Wales, Australia.
School of Physiotherapy, Western University, Elborn College, London, Canada.
BMJ Open. 2017 Aug 21;7(8):e013080. doi: 10.1136/bmjopen-2016-013080.
Chronic low back pain (LBP) is a common and costly health problem yet current treatments demonstrate at best, small effects. The concurrent application of treatments with synergistic clinical and mechanistic effects may improve outcomes in chronic LBP. This pilot trial aims to (1) determine the feasibility, safety and perceived patient response to a combined transcranial direct current stimulation (tDCS) and sensorimotor retraining intervention in chronic LBP and (2) provide data to support a sample size calculation for a fully powered trial should trends of effectiveness be present.
A pilot randomised, assessor and participant-blind, sham-controlled trial will be conducted. Eighty participants with chronic LBP will be randomly allocated to receive either (1) active tDCS + sensorimotor retraining or (2) sham tDCS + sensorimotor retraining. tDCS (active or sham) will be applied to the primary motor cortex for 20 min immediately prior to 60 min of supervised sensorimotor retraining twice per week for 10 weeks. Participants in both groups will complete home exercises three times per week. Feasibility, safety, pain, disability and pain system function will be assessed immediately before and after the 10-week intervention. Analysis of feasibility and safety will be performed using descriptive statistics. Statistical analyses will be conducted based on intention-to-treat and per protocol and will be used to determine trends for effectiveness.
Ethical approval has been gained from the institutional human research ethics committee (H10184). Written informed consent will be provided by all participants. Results from this pilot study will be submitted for publication in peer-reviewed journals.
ACTRN12616000624482.
慢性下腰痛（LBP）是一个常见且代价高昂的健康问题，但目前的治疗方法效果甚微。同时应用具有协同临床和机制效应的治疗方法可能会改善慢性LBP的治疗效果。这项试点试验旨在：（1）确定联合经颅直流电刺激（tDCS）和感觉运动再训练干预对慢性LBP的可行性、安全性及患者的感知反应；（2）若存在有效性趋势，提供数据以支持进行一项充分有力试验的样本量计算。
将进行一项试点随机、评估者和参与者双盲、假对照试验。80名慢性LBP患者将被随机分配接受以下两种治疗之一：（1）主动tDCS + 感觉运动再训练；（2）假tDCS + 感觉运动再训练。在每周两次、为期10周的60分钟有监督的感觉运动再训练前20分钟，将tDCS（主动或假刺激）应用于初级运动皮层。两组参与者每周还需进行三次家庭锻炼。在为期10周的干预前后，将对可行性、安全性、疼痛、残疾程度及疼痛系统功能进行评估。将使用描述性统计分析可行性和安全性。将基于意向性分析和符合方案分析进行统计分析，并用于确定有效性趋势。
已获得机构人类研究伦理委员会（H10184）的伦理批准。所有参与者将提供书面知情同意书。这项试点研究的结果将提交至同行评审期刊发表。
ACTRN12616000624482。
