Brosseau Lucie, Milne Sarah, Robinson Vivian, Marchand Serge, Shea Beverley, Wells George, Tugwell Peter
Physiotherapy Program, School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa, Ontario, Canada.
Spine (Phila Pa 1976). 2002 Mar 15;27(6):596-603. doi: 10.1097/00007632-200203150-00007.
Low back pain affects a large proportion of the population. Transcutaneous electrical nerve stimulation (TENS) was introduced more than 30 years ago as an alternative therapy to pharmacologic treatments for chronic pain. However, despite its widespread use, the efficacy of TENS is still controversial.
The aim of this meta-analysis was to determine the efficacy of TENS in the treatment of chronic low back pain.
The authors searched MEDLINE, EMBASE, PEDro, and the Cochrane Controlled Trials Register up to June 1, 2000. Only randomized controlled clinical trials of TENS for the treatment of patients with a clinical diagnosis of chronic low back pain were included. Abstracts were excluded unless further data could be obtained from the authors. Two reviewers independently selected trials and extracted data using predetermined forms.
Heterogeneity was tested with Cochrane's Q test. A fixed effects model was used throughout for continuous variables, except where heterogeneity existed, in which case, a random effects model was used. Results are presented as weighted mean differences with 95% confidence intervals, where the difference between the treated and control groups was weighted by the inverse of the variance. Standardized mean differences were calculated by dividing the difference between the treated and control by the baseline variance. Standardized mean differences were used when different scales were integrated to measure the same concept. Dichotomous outcomes were analyzed with odds ratios.
Five trials were included, with 170 subjects randomized to the placebo group receiving sham TENS and 251 subjects receiving active TENS (153 for conventional mode, 98 for acupuncture-like TENS). The schedule of treatments varied greatly between studies ranging from one treatment/day for 2 consecutive days, to three treatments/day for 4 weeks. There were no statistically significant differences between the active TENS group compared with the placebo TENS group for any outcome measures. Subgroup analysis performed on TENS application and methodologic quality did not demonstrate a significant statistical difference (P > 0.05). Remaining preplanned subgroup analysis was not conducted because of the small number of included trials and the variety of outcome measures reported.
The results of the meta-analysis present no evidence to support the use or nonuse of TENS alone in the treatment of chronic low back pain. Considering the small number of studies responding to the criteria to be included in this meta-analysis, it is clear that more appropriately designed studies are needed before a final conclusion. Clinicians and researchers should consistently report the characteristics of the TENS device and the application techniques used. New trials on TENS should make use of standardized outcome measures. This meta-analysis lacked data on how TENS efficacy is affected by four important factors: type of applications, site of application, treatment duration of TENS, and optimal frequencies and intensities.
下背痛影响着很大一部分人群。经皮电刺激神经疗法(TENS)于30多年前被引入,作为慢性疼痛药物治疗的替代疗法。然而,尽管其被广泛使用,TENS的疗效仍存在争议。
本荟萃分析的目的是确定TENS治疗慢性下背痛的疗效。
作者检索了截至2000年6月1日的MEDLINE、EMBASE、PEDro和Cochrane对照试验注册库。仅纳入了TENS治疗临床诊断为慢性下背痛患者的随机对照临床试验。除非能从作者处获得更多数据,否则排除摘要。两名评审员独立选择试验并使用预定表格提取数据。
使用Cochrane的Q检验来检验异质性。对于连续变量,除存在异质性的情况外,全程使用固定效应模型,此时使用随机效应模型。结果以加权平均差和95%置信区间表示,其中治疗组与对照组之间的差异通过方差倒数加权。标准化平均差通过将治疗组与对照组之间的差异除以基线方差来计算。当整合不同量表以测量相同概念时,使用标准化平均差。二分结果用比值比进行分析。
纳入了5项试验,170名受试者被随机分配到接受假TENS的安慰剂组,251名受试者接受活性TENS(153名采用传统模式,98名采用类针刺TENS)。各研究之间的治疗方案差异很大,从连续2天每天1次治疗到4周内每天3次治疗。在任何结局指标上,活性TENS组与安慰剂TENS组之间均无统计学显著差异。对TENS应用和方法学质量进行的亚组分析未显示出显著的统计学差异(P>0.05)。由于纳入试验数量较少且报告的结局指标多样,未进行其余预先计划的亚组分析。
荟萃分析结果没有证据支持单独使用或不使用TENS治疗慢性下背痛。考虑到符合本荟萃分析纳入标准的研究数量较少,显然在得出最终结论之前需要进行更合理设计的研究。临床医生和研究人员应始终报告TENS设备的特征和所使用的应用技术。关于TENS的新试验应采用标准化的结局指标。本荟萃分析缺乏关于TENS疗效如何受四个重要因素影响的数据:应用类型、应用部位、TENS治疗持续时间以及最佳频率和强度。