Luedtke Kerstin, Rushton Alison, Wright Christine, Jürgens Tim, Polzer Astrid, Mueller Gerd, May Arne
Department of Systems Neuroscience, University Medical Centre Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany.
School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
BMJ. 2015 Apr 16;350:h1640. doi: 10.1136/bmj.h1640.
To evaluate the effectiveness of transcranial direct current stimulation alone and in combination with cognitive behavioural management in patients with non-specific chronic low back pain.
Double blind parallel group randomised controlled trial with six months' follow-up conducted May 2011-March 2013. Participants, physiotherapists, assessors, and analyses were blinded to group allocation.
Interdisciplinary chronic pain centre.
135 participants with non-specific chronic low back pain >12 weeks were recruited from 225 patients assessed for eligibility.
Participants were randomised to receive anodal (20 minutes to motor cortex at 2 mA) or sham transcranial direct current stimulation (identical electrode position, stimulator switched off after 30 seconds) for five consecutive days immediately before cognitive behavioural management (four week multidisciplinary programme of 80 hours).
Two primary outcome measures of pain intensity (0-100 visual analogue scale) and disability (Oswestry disability index) were evaluated at two primary endpoints after stimulation and after cognitive behavioural management.
Analyses of covariance with baseline values (pain or disability) as covariates showed that transcranial direct current stimulation was ineffective for the reduction of pain (difference between groups on visual analogue scale 1 mm (99% confidence interval -8.69 mm to 6.3 mm; P=0.68)) and disability (difference between groups 1 point (-1.73 to 1.98; P=0.86)) and did not influence the outcome of cognitive behavioural management (difference between group 3 mm (-10.32 mm to 6.73 mm); P=0.58; difference between groups on Oswestry disability index 0 point (-2.45 to 2.62); P=0.92). The stimulation was well tolerated with minimal transitory side effects.
This results of this trial on the effectiveness of transcranial direct current stimulation for the reduction of pain and disability do not support its clinical use for managing non-specific chronic low back pain.Trial registration Current controlled trials ISRCTN89874874.
评估经颅直流电刺激单独应用以及联合认知行为管理对非特异性慢性下腰痛患者的疗效。
2011年5月至2013年3月进行的双盲平行组随机对照试验，随访6个月。参与者、物理治疗师、评估者及分析人员均对分组情况不知情。
跨学科慢性疼痛中心。
从225名接受资格评估的患者中招募了135名非特异性慢性下腰痛超过12周的参与者。
参与者被随机分为接受阳极经颅直流电刺激（以2毫安的电流刺激运动皮层20分钟）或假经颅直流电刺激（电极位置相同，30秒后关闭刺激器），在认知行为管理（为期四周、共80小时的多学科项目）前连续五天接受刺激。
在刺激后和认知行为管理后两个主要时间点，评估疼痛强度（0 - 100视觉模拟量表）和残疾程度（奥斯威斯残疾指数）这两个主要结局指标。
以基线值（疼痛或残疾）作为协变量的协方差分析表明，经颅直流电刺激在减轻疼痛（视觉模拟量表上组间差异为1毫米（99%置信区间 - 8.69毫米至6.3毫米；P = 0.68））和残疾程度（组间差异为1分（-1.73至1.98；P = 0.86））方面无效，且不影响认知行为管理的结果（组间差异为3毫米（-10.32毫米至6.73毫米）；P = 0.58；奥斯威斯残疾指数组间差异为0分（-2.45至2.62）；P = 0.92）。该刺激耐受性良好，短暂副作用极小。
本试验关于经颅直流电刺激减轻疼痛和残疾程度有效性的结果不支持其在管理非特异性慢性下腰痛中的临床应用。试验注册号：国际标准随机对照试验编号ISRCTN89874874。
