Momosaki Ryo, Yamada Naoki, Ota Erika, Abo Masahiro
Department of Rehabilitation Medicine, Teikyo University School of Medicine University Hospital, Mizonokuchi, 5-1-1 Futako, Takatsu-ku, Kawasaki, Kanagawa, Japan, 213-8507.
Cochrane Database Syst Rev. 2017 Jun 23;6(6):CD011968. doi: 10.1002/14651858.CD011968.pub2.
Repetitive peripheral magnetic stimulation (rPMS) is a form of therapy that creates painless stimulation of deep muscle structures to improve motor function in people with physical impairment from brain or nerve disorders. Use of rPMS for people after stroke has been identified as a feasible approach to improve activities of daily living and functional ability. However, no systematic reviews have assessed the findings of available trials. The effect and safety of this intervention for people after stroke currently remain uncertain.
To assess the effect of rPMS for improving activities of daily living and functional ability in people after stroke.
We searched the Cochrane Stroke Group Trials Register (August 2016), the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 8) in the Cochrane Library (August 2016), MEDLINE Ovid (November 2016), Embase Ovid (August 2016), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) in Ebsco (August 2016), PsycINFO Ovid (August 2016), the Allied and Complementary Medicine Database (AMED) Ovid (August 2016), Occupational Therapy Systematic Evaluation of Evidence (OTseeker) (August 2016), the Physiotherapy Evidence Database (PEDro) (October 2016), and ICHUSHI Web (October 2016). We also searched five ongoing trial registries, screened reference lists, and contacted experts in the field. We placed no restrictions on the language or date of publication when searching the electronic databases.
We included randomised controlled trials (RCTs) conducted to assess the therapeutic effect of rPMS for people after stroke. Comparisons eligible for inclusion were (1) active rPMS only compared with 'sham' rPMS (a very weak form of stimulation or a sound only); (2) active rPMS only compared with no intervention; (3) active rPMS plus rehabilitation compared with sham rPMS plus rehabilitation; and (4) active rPMS plus rehabilitation compared with rehabilitation only.
Two review authors independently assessed studies for inclusion. The same review authors assessed methods and risk of bias and extracted data. We contacted trial authors to ask for unpublished information if necessary. We resolved all disagreements through discussion.
We included three trials (two RCTs and one cross-over trial) involving 121 participants. Blinding of participants and physicians was well reported in all trials, and overall risk of bias was low. We found no clear effect of rPMS on activities of daily living at the end of treatment (mean difference (MD) -3.00, 95% confidence interval (CI) -16.35 to 10.35; low-quality evidence) and at the end of follow-up (MD -2.00, 95% CI -14.86 to 10.86; low-quality evidence). Investigators in one study with 63 participants observed no statistical difference in improvement of upper limb function at the end of treatment (MD 2.00, 95% CI -4.91 to 8.91) and at the end of follow-up (MD 4.00, 95% CI -2.92 to 10.92). One trial with 18 participants showed that rPMS treatment was not associated with improved muscle strength at the end of treatment (MD 3.00, 95% CI -2.44 to 8.44). Another study reported a significant decrease in spasticity of the elbow at the end of follow-up (MD -0.48, 95% CI -0.93 to -0.03). No studies provided information on lower limb function and death. Based on the GRADE approach, we judged the certainty of evidence related to the primary outcome as low owing to the small sample size of one study.
AUTHORS' CONCLUSIONS: Available trials provided inadequate evidence to permit any conclusions about routine use of rPMS for people after stroke. Additional trials with large sample sizes are needed to determine an appropriate rPMS protocol as well as long-term effects. We identified three ongoing trials and will include these trials in the next review update.
重复经颅磁刺激(rPMS)是一种治疗方法,可对深层肌肉结构进行无痛刺激,以改善因脑部或神经疾病导致身体功能受损者的运动功能。已确定对中风后患者使用rPMS是改善日常生活活动和功能能力的一种可行方法。然而,尚无系统评价评估现有试验的结果。目前,这种干预措施对中风后患者的效果和安全性仍不确定。
评估rPMS对改善中风后患者日常生活活动和功能能力的效果。
我们检索了Cochrane中风组试验注册库(2016年8月)、Cochrane图书馆中的Cochrane对照试验中心注册库(CENTRAL;2016年第8期)(2016年8月)、MEDLINE Ovid(2016年11月)、Embase Ovid(2016年8月)、Ebsco中的护理及相关健康文献累积索引(CINAHL)(2016年8月)、PsycINFO Ovid(2016年8月)、联合与补充医学数据库(AMED)Ovid(2016年8月)、职业治疗系统证据评估(OTseeker)(2016年8月)、物理治疗证据数据库(PEDro)(2016年10月)以及ICHUSHI网络(2016年10月)。我们还检索了五个正在进行的试验注册库,筛选了参考文献列表,并联系了该领域的专家。在检索电子数据库时,我们对语言或出版日期没有限制。
我们纳入了为评估rPMS对中风后患者的治疗效果而进行的随机对照试验(RCT)。符合纳入标准的比较包括:(1)仅将主动rPMS与“假”rPMS(一种非常弱的刺激形式或仅为声音)进行比较;(2)仅将主动rPMS与不进行干预进行比较;(3)将主动rPMS加康复治疗与假rPMS加康复治疗进行比较;(4)将主动rPMS加康复治疗与仅进行康复治疗进行比较。
两位综述作者独立评估纳入研究。同样的综述作者评估方法和偏倚风险并提取数据。如有必要,我们联系试验作者索要未发表的信息。我们通过讨论解决所有分歧。
我们纳入了三项试验(两项RCT和一项交叉试验),涉及121名参与者。所有试验均很好地报告了参与者和医生的盲法情况,总体偏倚风险较低。我们发现,在治疗结束时(平均差(MD)-3.00,95%置信区间(CI)-16.35至10.35;低质量证据)和随访结束时(MD -2.00,95%CI -14.86至10.86;低质量证据),rPMS对日常生活活动没有明显影响。一项有63名参与者的研究中的研究者观察到,在治疗结束时(MD 2.00,95%CI -4.91至8.91)和随访结束时(MD 4.00,95%CI -2.92至10.92),上肢功能改善无统计学差异。一项有18名参与者的试验表明,rPMS治疗在治疗结束时与肌肉力量改善无关(MD 3.00,95%CI -2.44至8.44)。另一项研究报告称,随访结束时肘部痉挛明显减轻(MD -0.48,95%CI -0.93至-0.03)。没有研究提供有关下肢功能和死亡的信息。基于GRADE方法,由于一项研究的样本量较小,我们判断与主要结局相关的证据确定性较低。
现有试验提供的证据不足,无法就中风后患者常规使用rPMS得出任何结论。需要更多大样本量的试验来确定合适的rPMS方案以及长期效果。我们确定了三项正在进行的试验,并将在下次综述更新时纳入这些试验。