Russo Marc, Nevitt Sarah, Santarelli Danielle, Eldabe Sam, Duarte Rui V
Hunter Pain Specialists, Broadmeadow, NSW 2292, Australia.
Genesis Research Services, Broadmeadow, NSW 2292, Australia.
Pain Med. 2025 Jun 1;26(6):337-347. doi: 10.1093/pm/pnaf004.
The aim of this review was to systematically identify all evidence that used conventional medical management (CMM) as a comparator in randomized controlled trials (RCTs) of spinal cord stimulation (SCS) therapy, and to conduct a meta-analysis to investigate if continued CMM provides statistical or clinically meaningful pain relief and whether CMM effects have improved over the last few decades.
Databases were searched from inception to June 2024 for RCTs that compared SCS to CMM. The primary outcome of the review was absolute change in pain intensity from baseline to the last available follow-up in the CMM group, measured using a visual analogue scale or numerical rating scale. The measure of treatment effect for absolute change and percentage change in pain intensity from baseline was mean difference (MD) and 95% confidence interval (CI). Risk of bias (RoB) was assessed by using the revised Cochrane RoB tool. The protocol for this review is registered on PROSPERO (CRD42023449215).
Meta-analysis of absolute change in pain intensity from baseline to last follow-up shows that CMM is not associated with any significant reductions in pain intensity (MD -0.11; 95% CI: -0.32 to 0.11; moderate certainty). Similar results were observed for percent change in pain intensity from baseline to last follow-up (MD -3.22%; 95% CI: -12.59% to 6.14%; moderate certainty). No significant differences were observed when considering decade of publication of the RCT for absolute (P = .065; moderate certainty) or percent change in pain intensity (P = 0.524; moderate certainty). Meta-analysis for 6-month follow-up and sensitivity analysis shows similar numerical results.
Our findings show that continued CMM for a population eligible for SCS does not provide meaningful pain relief and has not considerably changed over the last few decades. The use of CMM as the control to evaluate relative SCS treatment effects should be reassessed.
本综述旨在系统识别在脊髓刺激（SCS）治疗的随机对照试验（RCT）中使用传统医学管理（CMM）作为对照的所有证据，并进行荟萃分析，以研究持续进行CMM是否能提供具有统计学意义或临床意义的疼痛缓解，以及在过去几十年中CMM的效果是否有所改善。
检索从数据库创建至2024年6月的RCT，这些试验将SCS与CMM进行了比较。综述的主要结局是CMM组从基线到最后一次可用随访时疼痛强度的绝对变化，使用视觉模拟量表或数字评定量表进行测量。疼痛强度从基线的绝对变化和百分比变化的治疗效果衡量指标为平均差（MD）和95%置信区间（CI）。使用修订后的Cochrane偏倚风险（RoB）工具评估偏倚风险。本综述的方案已在PROSPERO（CRD42023449215）上注册。
对从基线到最后随访时疼痛强度绝对变化的荟萃分析表明，CMM与疼痛强度的任何显著降低均无关联（MD -0.11；95%CI：-0.32至0.11；中等确定性）。从基线到最后随访时疼痛强度百分比变化也观察到类似结果（MD -3.22%；95%CI：-12.59%至6.14%；中等确定性）。在考虑RCT发表年代时，对于疼痛强度的绝对变化（P = 0.065；中等确定性）或百分比变化（P = 0.524；中等确定性）均未观察到显著差异。6个月随访的荟萃分析和敏感性分析显示了类似的数值结果。
我们的研究结果表明，对符合SCS条件的人群持续进行CMM并不能提供有意义的疼痛缓解，且在过去几十年中没有显著变化。应重新评估将CMM用作对照来评估SCS相对治疗效果的做法。
