Gibson William, Wand Benedict M, O'Connell Neil E
School of Physiotherapy, The University of Notre Dame Australia, 19 Mouat Street (PO Box 1225), Fremantle, Western Australia, Australia, 6959.
Cochrane Database Syst Rev. 2017 Sep 14;9(9):CD011976. doi: 10.1002/14651858.CD011976.pub2.
Neuropathic pain, which is due to nerve disease or damage, represents a significant burden on people and society. It can be particularly unpleasant and achieving adequate symptom control can be difficult. Non-pharmacological methods of treatment are often employed by people with neuropathic pain and may include transcutaneous electrical nerve stimulation (TENS). This review supersedes one Cochrane Review 'Transcutaneous electrical nerve stimulation (TENS) for chronic pain' (Nnoaham 2014) and one withdrawn protocol 'Transcutaneous electrical nerve stimulation (TENS) for neuropathic pain in adults' (Claydon 2014). This review replaces the original protocol for neuropathic pain that was withdrawn.
To determine the analgesic effectiveness of TENS versus placebo (sham) TENS, TENS versus usual care, TENS versus no treatment and TENS in addition to usual care versus usual care alone in the management of neuropathic pain in adults.
We searched CENTRAL, MEDLINE, Embase, PsycINFO, AMED, CINAHL, Web of Science, PEDro, LILACS (up to September 2016) and various clinical trials registries. We also searched bibliographies of included studies for further relevant studies.
We included randomised controlled trials where TENS was evaluated in the treatment of central or peripheral neuropathic pain. We included studies if they investigated the following: TENS versus placebo (sham) TENS, TENS versus usual care, TENS versus no treatment and TENS in addition to usual care versus usual care alone in the management of neuropathic pain in adults.
Two review authors independently screened all database search results and identified papers requiring full-text assessment. Subsequently, two review authors independently applied inclusion/exclusion criteria to these studies. The same review authors then independently extracted data, assessed for risk of bias using the Cochrane standard tool and rated the quality of evidence using GRADE.
We included 15 studies with 724 participants. We found a range of treatment protocols in terms of duration of care, TENS application times and intensity of application. Briefly, duration of care ranged from four days through to three months. Similarly, we found variation of TENS application times; from 15 minutes up to hourly sessions applied four times daily. We typically found intensity of TENS set to comfortable perceptible tingling with very few studies titrating the dose to maintain this perception. Of the comparisons, we had planned to explore, we were only able to undertake a quantitative synthesis for TENS versus sham TENS. Insufficient data and large diversity in the control conditions prevented us from undertaking a quantitative synthesis for the remaining comparisons.For TENS compared to sham TENS, five studies were suitable for pooled analysis. We described the remainder of the studies in narrative form. Overall, we judged 11 studies at high risk of bias, and four at unclear risk. Due to the small number of eligible studies, the high levels of risk of bias across the studies and small sample sizes, we rated the quality of the evidence as very low for the pooled analysis and very low individual GRADE rating of outcomes from single studies. For the individual studies discussed in narrative form, the methodological limitations, quality of reporting and heterogeneous nature of interventions compared did not allow for reliable overall estimates of the effect of TENS.Five studies (across various neuropathic conditions) were suitable for pooled analysis of TENS versus sham TENS investigating change in pain intensity using a visual analogue scale. We found a mean postintervention difference in effect size favouring TENS of -1.58 (95% confidence interval (CI) -2.08 to -1.09, P < 0.00001, n = 207, six comparisons from five studies) (very low quality evidence). There was no significant heterogeneity in this analysis. While this exceeded our prespecified minimally important difference for pain outcomes, we assessed the quality of evidence as very low meaning we have very little confidence in this effect estimate and the true effect is likely to be substantially different from that reported in this review. Only one study of these five investigated health related quality of life as an outcome meaning we were unable to report on this outcome in this comparison. Similarly, we were unable to report on global impression of change or changes in analgesic use in this pooled analysis.Ten small studies compared TENS to some form of usual care. However, there was great diversity in what constituted usual care, precluding pooling of data. Most of these studies found either no difference in pain outcomes between TENS versus other active treatments or favoured the comparator intervention (very low quality evidence). We were unable to report on other primary and secondary outcomes in these single trials (health-related quality of life, global impression of change and changes in analgesic use).Of the 15 included studies, three reported adverse events which were minor and limited to 'skin irritation' at or around the site of electrode placement (very low quality evidence). Three studies reported no adverse events while the remainder did not report any detail with regard adverse events.
AUTHORS' CONCLUSIONS: In this review, we reported on the comparison between TENS and sham TENS. The quality of the evidence was very low meaning we were unable to confidently state whether TENS is effective for pain control in people with neuropathic pain. The very low quality of evidence means we have very limited confidence in the effect estimate reported; the true effect is likely to be substantially different. We make recommendations with respect to future TENS study designs which may meaningfully reduce the uncertainty relating to the effectiveness of this treatment modality.
神经性疼痛是由神经疾病或损伤引起的,给个人和社会带来了沉重负担。它可能特别令人不适,且难以实现充分的症状控制。神经性疼痛患者常采用非药物治疗方法,其中可能包括经皮电刺激神经疗法(TENS)。本综述取代了一篇Cochrane系统评价《经皮电刺激神经疗法(TENS)治疗慢性疼痛》(Nnoaham,2014年)和一篇撤回的方案《经皮电刺激神经疗法(TENS)治疗成人神经性疼痛》(Claydon,2014年)。本综述替代了已撤回的关于神经性疼痛的原始方案。
确定在成人神经性疼痛管理中,TENS与安慰剂(假)TENS、TENS与常规护理、TENS与不治疗以及TENS联合常规护理与单纯常规护理相比的镇痛效果。
我们检索了Cochrane系统评价数据库、医学期刊数据库(MEDLINE)、荷兰医学文摘数据库(Embase)、心理学文摘数据库(PsycINFO)、联合和补充医学数据库(AMED)、护理学与健康领域数据库(CINAHL)、科学引文索引数据库(Web of Science)、循证医学数据库(PEDro)、拉丁美洲和加勒比地区健康科学文献数据库(LILACS,截至2016年9月)以及各种临床试验注册库。我们还检索了纳入研究的参考文献以获取更多相关研究。
我们纳入了对TENS治疗中枢性或周围性神经性疼痛进行评估的随机对照试验。如果研究调查了以下内容,则纳入本综述:TENS与安慰剂(假)TENS、TENS与常规护理、TENS与不治疗以及TENS联合常规护理与单纯常规护理相比在成人神经性疼痛管理中的效果。
两位综述作者独立筛选所有数据库检索结果,并确定需要进行全文评估的论文。随后,两位综述作者独立对这些研究应用纳入/排除标准。同样由这两位综述作者独立提取数据,使用Cochrane标准工具评估偏倚风险,并使用GRADE对证据质量进行评级。
我们纳入了15项研究,共724名参与者。我们发现护理时长、TENS应用时间和应用强度方面的一系列治疗方案。简而言之,护理时长从四天到三个月不等。同样,我们发现TENS应用时间存在差异,从15分钟到每天应用四次、每次一小时不等。我们通常发现TENS强度设定为舒适的可感知刺痛感,只有极少数研究对剂量进行滴定以维持这种感觉。在我们计划探索的比较中,我们仅能对TENS与假TENS进行定量综合分析。数据不足以及对照条件的巨大差异使我们无法对其余比较进行定量综合分析。对于TENS与假TENS的比较,五项研究适合进行汇总分析。我们以叙述形式描述了其余研究。总体而言,我们判断11项研究存在高偏倚风险,4项研究偏倚风险不明。由于符合条件的研究数量少、研究中偏倚风险水平高以及样本量小,我们将汇总分析的证据质量评为极低,单项研究结果的GRADE评级也为极低。对于以叙述形式讨论的单项研究,方法学局限性、报告质量以及所比较干预措施的异质性使得无法对TENS的效果进行可靠的总体估计。五项研究(涉及各种神经性疾病)适合对TENS与假TENS进行汇总分析,使用视觉模拟量表调查疼痛强度的变化。我们发现干预后效应大小的平均差异有利于TENS,为 -1.58(95%置信区间(CI)-2.08至 -1.09,P < 0.00001,n = 207,来自五项研究的六个比较)(极低质量证据)。该分析中无显著异质性。虽然这超过了我们预先设定的疼痛结果最小重要差异,但我们将证据质量评为极低,这意味着我们对该效应估计几乎没有信心,真实效应可能与本综述报告的结果有很大不同。这五项研究中只有一项将与健康相关的生活质量作为结果进行调查,这意味着我们无法在该比较中报告此结果。同样,在该汇总分析中,我们无法报告总体变化印象或镇痛药物使用的变化。十项小型研究将TENS与某种形式的常规护理进行了比较。然而,构成常规护理的内容差异很大,无法进行数据汇总。这些研究中的大多数发现TENS与其他积极治疗之间在疼痛结果上没有差异,或者更倾向于对照干预措施(极低质量证据)。在这些单项试验中,我们无法报告其他主要和次要结果(与健康相关的生活质量、总体变化印象和镇痛药物使用的变化)。在纳入的15项研究中,三项报告了不良事件,均较轻微,仅限于电极放置部位或其周围的“皮肤刺激”(极低质量证据)。三项研究报告无不良事件,其余研究未报告任何关于不良事件的细节。
在本综述中,我们报告了TENS与假TENS的比较。证据质量极低,这意味着我们无法自信地说明TENS对神经性疼痛患者的疼痛控制是否有效。极低的证据质量意味着我们对报告的效应估计信心有限;真实效应可能有很大不同。我们针对未来TENS研究设计提出了建议,这可能会显著减少与这种治疗方式有效性相关的不确定性。