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经皮电刺激神经疗法(TENS)治疗慢性疼痛——Cochrane系统评价综述

Transcutaneous electrical nerve stimulation (TENS) for chronic pain - an overview of Cochrane Reviews.

作者信息

Gibson William, Wand Benedict M, Meads Catherine, Catley Mark J, O'Connell Neil E

机构信息

School of Physiotherapy, The University of Notre Dame Australia, 19 Mouat Street (PO Box 1225), Fremantle, Western Australia, Australia, 6959.

出版信息

Cochrane Database Syst Rev. 2019 Apr 3;4(4):CD011890. doi: 10.1002/14651858.CD011890.pub3.

Abstract

BACKGROUND

Chronic pain, considered to be pain lasting more than three months, is a common and often difficult to treat condition that can significantly impact upon function and quality of life. Treatment typically includes pharmacological and non-pharmacological approaches. Transcutaneous electrical nerve stimulation (TENS) is an adjunct non-pharmacological treatment commonly recommended by clinicians and often used by people with pain.

OBJECTIVES

To provide an overview of evidence from Cochrane Reviews of the effectiveness of TENS to reduce pain in adults with chronic pain (excluding headache or migraine).To provide an overview of evidence from Cochrane Reviews of the safety of TENS when used to reduce pain in adults with chronic pain (excluding headache or migraine).To identify possible sources of inconsistency in the approaches taken to evaluating the evidence related to TENS for chronic pain (excluding headache or migraine) in the Cochrane Library with a view to recommending strategies to improve consistency in methodology and reporting.To highlight areas of remaining uncertainty regarding the effectiveness of TENS for chronic pain (excluding headache or migraine) with a view to recommending strategies to reduce any uncertainty.

METHODS

Search methodsWe searched the Cochrane Database of Systematic Reviews (CDSR), in the Cochrane Library, across all years up to Issue 11 of 12, 2018.Selection of reviewsTwo authors independently screened the results of the electronic search by title and abstract against inclusion/exclusion criteria. We included all Cochrane Reviews of randomised controlled trials (RCTs) assessing the effectiveness of TENS in people with chronic pain. We included reviews if they investigated the following: TENS versus sham; TENS versus usual care or no treatment/waiting list control; TENS plus active intervention versus active intervention alone; comparisons between different types of TENS; or TENS delivered using different stimulation parameters.Data extraction and analysisTwo authors independently extracted relevant data, assessed review quality using the AMSTAR checklist and applied GRADE judgements where required to individual reviews. Our primary outcomes included pain intensity and nature/incidence of adverse effects; our secondary outcomes included disability, health-related quality of life, analgesic medication use and participant global impression of change.

MAIN RESULTS

We included nine reviews investigating TENS use in people with defined chronic pain or in people with chronic conditions associated with ongoing pain. One review investigating TENS for phantom or stump-associated pain in people following amputation did not have any included studies. We therefore extracted data from eight reviews which represented 51 TENS-related RCTs representing 2895 TENS-comparison participants entered into the studies.The included reviews followed consistent methods and achieved overall high scores on the AMSTAR checklist. The evidence reported within each review was consistently rated as very low quality. Using review authors' assessment of risk of bias, there were significant methodological limitations in included studies; and for all reviews, sample sizes were consistently small (the majority of studies included fewer than 50 participants per group).Six of the eight reviews presented a narrative synthesis of included studies. Two reviews reported a pooled analysis.Primary and secondary outcomes One review reported a beneficial effect of TENS versus sham therapy at reducing pain intensity on a 0 to 10 scale (MD -1.58, 95% CI -2.08 to -1.09, P < 0.001, I² = 29%, P = 0.22, 5 studies, 207 participants). However the quality of the evidence was very low due to significant methodological limitations and imprecision. A second review investigating pain intensity performed a pooled analysis by combining studies that compared TENS to sham with studies that compared TENS to no intervention (SMD -0.85, 95% CI -1.36 to -0.34, P = 0.001, I² = 83%, P < 0.001). This pooled analysis was judged as offering very low quality evidence due to significant methodological limitations, large between-trial heterogeneity and imprecision. We considered the approach of combining sham and no intervention data to be problematic since we would predict these different comparisons may be estimating different true effects. All remaining reviews also reported pain intensity as an outcome measure; however the data were presented in narrative review form only.Due to methodological limitation and lack of useable data, we were unable to offer any meaningful report on the remaining primary outcome regarding nature/incidence of adverse effects, nor for the remaining secondary outcomes: disability, health-related quality of life, analgesic medication use and participant global impression of change for any comparisons.We found the included reviews had a number of inconsistencies when evaluating the evidence from TENS studies. Approaches to assessing risk of bias around the participant, personnel and outcome-assessor blinding were perhaps the most obvious area of difference across included reviews. We also found wide variability in terms of primary and secondary outcome measures, and inclusion/exclusion criteria for studies varied with respect to including studies which assessed immediate effects of single interventions.

AUTHORS' CONCLUSIONS: We found the methodological quality of the reviews was good, but quality of the evidence within them was very low. We were therefore unable to conclude with any confidence that, in people with chronic pain, TENS is harmful, or beneficial for pain control, disability, health-related quality of life, use of pain relieving medicines, or global impression of change. We make recommendations with respect to future TENS study designs which may meaningfully reduce the uncertainty relating to the effectiveness of this treatment in people with chronic pain.

摘要

背景

慢性疼痛被认为是持续时间超过三个月的疼痛,是一种常见且通常难以治疗的病症,会对功能和生活质量产生重大影响。治疗通常包括药物治疗和非药物治疗方法。经皮电刺激神经疗法(TENS)是一种辅助非药物治疗方法,临床医生通常会推荐使用,疼痛患者也经常使用。

目的

概述Cochrane系统评价中关于TENS减轻慢性疼痛(不包括头痛或偏头痛)成人疼痛有效性的证据。概述Cochrane系统评价中关于TENS用于减轻慢性疼痛(不包括头痛或偏头痛)成人疼痛安全性的证据。识别Cochrane图书馆中评估TENS治疗慢性疼痛(不包括头痛或偏头痛)相关证据的方法中可能存在的不一致来源,以期推荐提高方法学和报告一致性的策略。强调TENS治疗慢性疼痛(不包括头痛或偏头痛)有效性方面仍存在不确定性的领域,以期推荐减少不确定性的策略。

方法

检索方法我们检索了Cochrane系统评价数据库(CDSR),该数据库收录于Cochrane图书馆,涵盖截至2018年第12期第11号的所有年份。综述的选择两位作者根据纳入/排除标准,独立通过标题和摘要筛选电子检索结果。我们纳入了所有评估TENS对慢性疼痛患者有效性的Cochrane随机对照试验(RCT)系统评价。如果综述研究了以下内容,我们则将其纳入:TENS与假刺激;TENS与常规护理或不治疗/等待列表对照;TENS加积极干预与单独积极干预;不同类型TENS之间的比较;或使用不同刺激参数进行的TENS治疗。数据提取和分析两位作者独立提取相关数据,使用AMSTAR清单评估综述质量,并在需要时对各个综述应用GRADE判断。我们的主要结局包括疼痛强度和不良反应的性质/发生率;次要结局包括残疾、健康相关生活质量、止痛药物使用和参与者对变化的总体印象。

主要结果

我们纳入了9项关于TENS用于特定慢性疼痛患者或与持续性疼痛相关慢性病患者的综述。一项关于截肢后患者幻肢或残端相关疼痛的TENS研究没有纳入任何研究。因此,我们从8项综述中提取了数据,这些综述代表了51项与TENS相关的RCT,涉及2895名参与TENS比较研究的参与者。纳入的综述采用了一致的方法,在AMSTAR清单上总体得分较高。每项综述中报告的证据质量一直被评为极低质量。根据综述作者对偏倚风险的评估,纳入研究存在显著的方法学局限性;并且对于所有综述,样本量一直较小(大多数研究每组纳入的参与者少于50人)。八项综述中有六项对纳入研究进行了叙述性综合分析。两项综述报告了汇总分析。主要和次要结局一项综述报告,与假刺激疗法相比,TENS在减轻0至10级疼痛强度方面有有益效果(MD -1.58,95%CI -2.08至-1.09,P < 0.001,I² = 29%,P = 0.22,5项研究,207名参与者)。然而,由于显著的方法学局限性和不精确性,证据质量极低。另一项关于疼痛强度的综述通过将比较TENS与假刺激的研究和比较TENS与无干预的研究进行合并,进行了汇总分析(SMD -0.85,95%CI -1.36至-0.34,P = 0.001,I² = 83%,P < 0.001)。由于显著的方法学局限性、试验间的巨大异质性和不精确性,该汇总分析被判定为提供极低质量的证据。我们认为将假刺激和无干预数据合并的方法存在问题,因为我们预计这些不同的比较可能在估计不同的真实效应。其余所有综述也将疼痛强度作为结局指标;然而,数据仅以叙述性综述形式呈现。由于方法学局限性和缺乏可用数据,我们无法就其余主要结局(不良反应的性质/发生率)以及其余次要结局(残疾、健康相关生活质量、止痛药物使用和参与者对变化的总体印象)进行任何有意义的报告。我们发现纳入的综述在评估TENS研究证据时存在一些不一致之处。在参与者、研究人员和结局评估者盲法方面评估偏倚风险的方法可能是纳入综述中最明显的差异领域。我们还发现,主要和次要结局指标存在很大差异,研究的纳入/排除标准在是否纳入评估单一干预即时效应的研究方面也有所不同。

作者结论

我们发现综述的方法学质量良好,但其中证据的质量极低。因此,我们无法确定对于慢性疼痛患者,TENS是有害的,还是对疼痛控制、残疾、健康相关生活质量、止痛药物使用或变化的总体印象有益。我们就未来TENS研究设计提出了建议,这些设计可能会有意义地减少关于这种治疗对慢性疼痛患者有效性的不确定性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d8e/6446021/dc3a3179fc5d/nCD011890-AFig-FIG01.jpg

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