Department of Pain Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
Clin J Pain. 2024 Jul 1;40(7):415-427. doi: 10.1097/AJP.0000000000001215.
The aim of our meta-analysis was to systematically assess the enduring effectiveness and safety of high-frequency spinal stimulation (HF-SCS) in the management of chronic pain.
We developed a comprehensive literature search strategy to identify clinical trials investigating the efficacy of high-frequency spinal stimulation for chronic pain. The search was conducted in multiple databases, including Web of Science, Cochrane, PubMed, and Embase, covering the period from 2004 to 2023. The inclusion and exclusion criteria established for this study were applied to screen the eligible literature by carefully reviewing abstracts and, when necessary, examining the full text of selected articles. To assess the quality of the included studies, we utilized the Risk of Bias assessment tool provided by the Cochrane Collaboration. The PRISMA method was followed for the selection of articles, and the quality of the articles was evaluated using the risk assessment table for bias provided by the Cochrane Collaboration. Meta-analysis of the selected studies was performed using Review Manager 5.4 and STATA 16.0. Effect sizes for continuous data were reported as mean differences (MD) or standardized mean differences (SMD), while categorical data were analyzed using relative risks (RR).
According to our predefined literature screening criteria, a total of seven English-language randomized controlled trials (RCTs) were included in the meta-analysis. The findings from the meta-analysis demonstrated that HF-SCS exhibited superior efficacy in the long-term treatment of chronic pain when compared with the control group (RR=2.44, 95% CI: 1.20-4.96, P =0.01). Furthermore, HF-SCS demonstrated a statistically significant improvement in the Oswestry Disability Index score (mean difference MD=3.77, 95% CI: 1.17-6.38, P =0.005). However, for pain assessment (standardized mean difference SMD=-0.59, 95% CI: -1.28 to 0.10, P =0.09), Patient Global Impression of Improvement (PGI-I) score (MD=0.11, 95% CI: -0.66 to 0.88, P =0.78 for 6 months; MD=0.02, 95% CI: -0.42 to 0.43, P =0.97 for 12 mo), Clinical Global Impression of Improvement (CGI-I) score (MD=-0.58, 95% CI: -1.62 to 0.43, P =0.27 for 6 mo; MD=-0.23, 95% CI: -0.94 to 0.48, P =0.52 for 12 mo), and occurrence of adverse effects (odds ratio [OR]=0.77, 95% CI: 0.23-2.59, P =0.67), HF-SCS did not show statistically sufficient effects compared with the control group.
The findings from our comprehensive review and meta-analysis offer encouraging data about the prolonged efficacy and safety of HF-SCS in chronic pain management on some but not all outcomes. Recognizing the constraints of the existing evidence is crucial. Additional clinical trials, meticulously planned and stringent, are essential to bolster the current body of evidence and reach more conclusive findings.
本荟萃分析旨在系统评估高频脊髓刺激（HF-SCS）在慢性疼痛管理中的长期疗效和安全性。
我们制定了全面的文献检索策略，以确定关于高频脊髓刺激治疗慢性疼痛疗效的临床试验。检索涵盖了多个数据库，包括 Web of Science、Cochrane、PubMed 和 Embase，时间跨度为 2004 年至 2023 年。通过仔细审查摘要，并在必要时检查选定文章的全文，应用本研究建立的纳入和排除标准筛选合格文献。为评估纳入研究的质量，我们使用了 Cochrane 协作提供的偏倚风险评估工具。我们遵循 PRISMA 方法进行文章选择，并使用 Cochrane 协作提供的偏倚风险评估表评估文章的质量。使用 Review Manager 5.4 和 STATA 16.0 对选定的研究进行荟萃分析。连续数据的效应大小以均数差（MD）或标准化均数差（SMD）表示，而分类数据使用相对风险（RR）进行分析。
根据我们预先设定的文献筛选标准，共有 7 项英语随机对照试验（RCT）纳入荟萃分析。荟萃分析结果表明，与对照组相比，HF-SCS 在慢性疼痛的长期治疗中具有更好的疗效（RR=2.44，95%CI：1.20-4.96，P=0.01）。此外，HF-SCS 在 Oswestry 残疾指数评分方面表现出统计学显著改善（均数差 MD=3.77，95%CI：1.17-6.38，P=0.005）。然而，对于疼痛评估（标准化均数差 SMD=-0.59，95%CI：-1.28 至 0.10，P=0.09）、患者总体印象改善评分（PGI-I）（MD=0.11，95%CI：-0.66 至 0.88，P=0.78 为 6 个月；MD=0.02，95%CI：-0.42 至 0.43，P=0.97 为 12 个月）、临床总体印象改善评分（CGI-I）（MD=-0.58，95%CI：-1.62 至 0.43，P=0.27 为 6 个月；MD=-0.23，95%CI：-0.94 至 0.48，P=0.52 为 12 个月）和不良反应发生率（比值比[OR]=0.77，95%CI：0.23-2.59，P=0.67），HF-SCS 与对照组相比，并未显示出统计学上足够的效果。
我们的全面综述和荟萃分析结果提供了令人鼓舞的证据，表明 HF-SCS 在慢性疼痛管理中的长期疗效和安全性，但并非所有结果均如此。认识到现有证据的局限性至关重要。需要更多精心设计和严格的临床试验来增强当前的证据基础，并得出更具结论性的发现。
