METHODS: A comprehensive electronic search of the literature published in electronic databases, including Ovid MEDLINE and Epub Ahead of Print, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus, was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The outcomes of interest were reduction in back pain and/or leg pain after conversion from conventional to novel SCSs. Risk of bias was assessed with the Risk of Bias in Nonrandomized Studies of Interventions (ROBINS-I) tool. The strength of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) criteria.
RESULTS: A total of 6 studies with 137 patients with FBSS were identified. Studies were published between 2013 and 2021. The mean ± SD age of the pooled patient sample was 55 ± 10.5 years. All patients who underwent treatment with conventional SCSs were identified. Two studies evaluated the efficacy of high-density spinal cord stimulation, 3 studies evaluated burst spinal cord stimulation, and 1 study assessed multimodal waveforms. The mean difference in back pain scores after conversion from a standard SCS to a novel waveform SCS was 2.55 (95% CI 1.59-4.08), demonstrating a significant reduction in back pain after conversion to novel stimulation. The authors also performed a subgroup analysis to compare burst stimulation to tonic waveforms. In this analysis, the authors found no significant difference in the average reductions in back pain between the 2 groups (p = 0.534).The authors found an I2 statistic equivalent to 98.47% in the meta-regression model used to assess the effect of follow-up duration on study outcome; this value implied that the variability in the data can be attributed to the remaining between-study heterogeneity. The overall certainty was moderate, with a high risk of bias across studies.
CONCLUSIONS: Rescue therapy with novel waveform spinal cord stimulation is a potential option for pain reduction in patients who become refractory to conventional SCSs. Conversion to novel waveform SCSs may potentially mitigate expenses and complications.
方法:对电子数据库中发表的文献进行全面的电子搜索,包括OvidMEDLINE和Epub,OvidCochrane中央控制试验登记册,OvidCochrane系统评价数据库,还有Scopus,使用系统评价和荟萃分析(PRISMA)指南的首选报告项目进行。感兴趣的结果是从常规SCS转换为新型SCS后,背痛和/或腿部疼痛减少。使用非随机干预研究(ROBINS-I)工具中的偏倚风险评估偏倚风险。使用建议分级评估证据的强度,评估,开发和评估(等级)标准。
结果:共有6项研究纳入137例FBSS患者。研究发表于2013年至2021年之间。合并患者样本的平均±SD年龄为55±10.5岁。确定所有接受常规SCSs治疗的患者。两项研究评估了高密度脊髓刺激的疗效,3项研究评估了爆发性脊髓刺激,1项研究评估了多模态波形。从标准SCS转换为新波形SCS后,背痛评分的平均差异为2.55(95%CI1.59-4.08),证明转换为新型刺激后背痛显着减轻。作者还进行了亚组分析,以将爆发刺激与强直波形进行比较。在这个分析中,作者发现两组间背痛的平均减轻没有显著差异(p=0.534).作者发现,在用于评估随访持续时间对研究结果的影响的荟萃回归模型中,I2统计量相当于98.47%;该值暗示数据的变异性可归因于剩余的研究间异质性。总体确定性适中,在研究中存在很高的偏倚风险。
结论:新型波形脊髓刺激的抢救治疗是减轻常规SCS难治性患者疼痛的潜在选择。转换到新波形SCS可以潜在地减轻费用和复杂性。