O'Connell Neil E, Wand Benedict M, Marston Louise, Spencer Sally, Desouza Lorraine H
Centre for Research in Rehabilitation, School of Health Sciences and Social Care, Brunel University, Kingston Lane, Uxbridge, Middlesex, UK, UB8 3PH.
Cochrane Database Syst Rev. 2010 Sep 8(9):CD008208. doi: 10.1002/14651858.CD008208.pub2.
Non-invasive brain stimulation techniques aim to induce an electrical stimulation of the brain in an attempt to reduce chronic pain by directly altering brain activity. They include repetitive transcranial magnetic stimulation (rTMS), cranial electrotherapy stimulation (CES) and transcranial direct current stimulation (tDCS).
To evaluate the efficacy of non-invasive brain stimulation techniques in chronic pain.
We searched CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, LILACS, the Cochrane PaPaS Group Trials Register and clinical trials registers.
Randomised and quasi-randomised studies of rTMS, CES or tDCS if they employed a sham stimulation control group, recruited patients over the age of 18 with pain of three months duration or more and measured pain as a primary outcome.
Two authors independently extracted and verified data. Where possible we entered data into meta-analyses. We excluded studies judged as being at high risk of bias from the analysis.
We included 33 trials in the review (involving 937 people)(19 rTMS, eight CES and six tDCS). Only one study was judged as being at low risk of bias.Studies of rTMS (involving 368 participants ) demonstrated significant heterogeneity. Pre-specified subgroup analyses suggest that low-frequency stimulation is ineffective. A short-term effect on pain of active high-frequency stimulation of the motor cortex in single-dose studies was suggested (standardised mean difference (SMD) -0.40, 95% confidence interval (CI) -0.26 to -0.54, P < 0.00001). This equates to a 15% (95% CI 10% to 20%) reduction in pain which does not clearly exceed the pre-established criteria for a minimally clinically important difference (> 15%).For CES (four studies, 133 participants) no statistically significant difference was found between active stimulation and sham. Analysis of tDCS studies (five studies, 83 people) demonstrated significant heterogeneity and did not find a significant difference between active and sham stimulation. Pre-specified subgroup analysis of tDCS applied to the motor cortex suggested superiority of active stimulation over sham (SMD -0.59, 95% CI -1.10 to -0.08).Non-invasive brain stimulation appears to be associated with minor and transient side effects.
AUTHORS' CONCLUSIONS: Single doses of high-frequency rTMS of the motor cortex may have small short-term effects on chronic pain. The effects do not clearly exceed the predetermined threshold of minimal clinical significance. Low-frequency rTMS is not effective in the treatment of chronic pain. There is insufficient evidence from which to draw firm conclusions regarding the efficacy of CES or tDCS. The available evidence suggests that tDCS applied to the motor cortex may have short-term effects on chronic pain and that CES may be ineffective. There is a need for further, rigorously designed studies of all types of stimulation.
非侵入性脑刺激技术旨在通过直接改变大脑活动来诱导对大脑的电刺激,以减轻慢性疼痛。这些技术包括重复经颅磁刺激(rTMS)、颅电刺激(CES)和经颅直流电刺激(tDCS)。
评估非侵入性脑刺激技术治疗慢性疼痛的疗效。
我们检索了Cochrane系统评价数据库、MEDLINE、EMBASE、护理学与健康领域数据库、心理学文摘数据库、拉丁美洲和加勒比卫生科学数据库、Cochrane疼痛、姑息和支持治疗小组试验注册库以及临床试验注册库。
rTMS、CES或tDCS的随机和半随机研究,条件为设有假刺激对照组,纳入年龄在18岁以上、疼痛持续三个月或更长时间的患者,并将疼痛作为主要结局指标进行测量。
两位作者独立提取并核实数据。我们尽可能将数据纳入荟萃分析。我们将被判定为存在高偏倚风险的研究排除在分析之外。
我们在综述中纳入了33项试验(涉及937人)(19项rTMS试验、8项CES试验和6项tDCS试验)。只有一项研究被判定为低偏倚风险。rTMS研究(涉及368名参与者)显示出显著的异质性。预先设定的亚组分析表明低频刺激无效。单剂量研究提示运动皮层主动高频刺激对疼痛有短期效应(标准化均数差(SMD)-0.40,95%置信区间(CI)-0.26至-0.54,P<0.00001)。这相当于疼痛减轻15%(95%CI 10%至20%),但并未明确超过预先设定的最小临床重要差异标准(>15%)。对于CES(四项研究,133名参与者),主动刺激与假刺激之间未发现统计学显著差异。tDCS研究分析(五项研究,83人)显示出显著的异质性,且主动刺激与假刺激之间未发现显著差异。对应用于运动皮层的tDCS进行预先设定的亚组分析提示主动刺激优于假刺激(SMD -0.59,95%CI -1.10至-0.08)。非侵入性脑刺激似乎与轻微和短暂的副作用相关。
单剂量运动皮层高频rTMS可能对慢性疼痛有较小的短期效应。这些效应并未明确超过预先确定的最小临床意义阈值。低频rTMS对慢性疼痛治疗无效。关于CES或tDCS的疗效,尚无足够证据得出确切结论。现有证据表明,应用于运动皮层的tDCS可能对慢性疼痛有短期效应,而CES可能无效。需要对所有类型的刺激进行进一步的严格设计研究。