Glinka Przybysz Allison, Vu To-Nhu, Pisansky Andrew J B, Schuster Nathaniel M, Sheth Samir, Cheng David S, Lobel Steven M, Binler Danielle, Duszynski Belinda, Conger Aaron, Schneider Byron J, Mattie Ryan
Department of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, UT, USA.
Department of Anesthesiology and Perioperative Medicine, Penn State Milton S. Hershey Medical Center, Hershey, PA, USA.
Interv Pain Med. 2025 Aug 22;4(3):100635. doi: 10.1016/j.inpm.2025.100635. eCollection 2025 Sep.
To assess the effectiveness of dorsal column spinal cord stimulation (SCS) in treating persistent spinal pain syndrome - Type 2 (PSPS-T2).
Systematic review.
PICOS (Population, Intervention, Comparison, Outcomes, and Studies) criteria were developed to include randomized controlled trials (RCTs) examining dorsal column stimulation for PSPS-T2 compared to conventional medical management or sham. Eight reviewers independently assessed publications through April 2025 and utilized the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) framework to evaluate the overall quality of evidence. Outcomes included measures of pain, function, quality of life, and adverse events.
Of the 1988 publications initially screened, six publications were included, comprising a total of 448 participants, of which 257 were randomized to an SCS trial and 220 ultimately received SCS implants. Follow-up periods for the primary endpoints varied across the studies, ranging from 1 month to 2 years. For studies reporting success rates for achieving at least a 50% reduction in pain, responder rates spanned from 14% to 80% in the tonic SCS groups, compared with 3%-20% for CMM. The mean improvement in pain levels between 1 month and 6 months varied between 16% and 48% for tonic SCS, 16 and 17% for burst SCS, -15% and 16% for CMM, and 10 and 16% for sham. The mean improvement in function at six months ranged from 21 to 45% for the tonic SCS group, compared with 0-21% for CMM. Adverse events reported in these studies included lead migration (10-14%), IPG site pain (1-12%), infection (6.9-10%), and dural puncture (6%). Cochrane risk of bias assessments revealed low risks for one-third of the included studies, while some concerns were noted for over half of the studies. According to the GRADE system, based on the available RCTs, there is moderate-quality evidence overall that SCS is clinically effective in reducing pain and disability in patients with PSPS-T2 at 6 months.
DISCUSSION/CONCLUSION: Substantial proportions of patients achieved ≥50% relief at 6 months following tonic SCS when compared with CMM, demonstrating clinical effectiveness. Significant improvements in function and quality of life were observed at study endpoints ranging from 3 to 24 months following tonic SCS. No studies included in this review utilized newer and potentially more effective SCS technologies such as closed loop, high frequency, or multiple waveform SCS. The only sham-controlled study included did not demonstrate efficacy of burst SCS. Adverse event rates, including infection and implant site pain, varied significantly between studies, with the newer and older studies representing the lower and upper ends of these ranges, respectively.
评估脊髓背柱刺激术（SCS）治疗2型持续性脊髓疼痛综合征（PSPS-T2）的有效性。
系统评价。
制定PICOS（人群、干预措施、对照、结局和研究）标准，纳入比较脊髓背柱刺激术与传统药物治疗或假手术治疗PSPS-T2的随机对照试验（RCT）。8名评审员独立评估截至2025年4月的出版物，并使用推荐分级、评估、制定和评价（GRADE）框架评估证据的总体质量。结局包括疼痛、功能、生活质量和不良事件的测量指标。
在最初筛选的1988篇出版物中，纳入了6篇出版物，共448名参与者，其中257名被随机分配到SCS试验组，220名最终接受了SCS植入。各研究中主要终点的随访期各不相同，从1个月到2年不等。对于报告疼痛至少减轻50%成功率的研究，强直性SCS组的缓解率为14%至80%，而传统药物治疗组为3%至20%。强直性SCS组在1个月至6个月间疼痛水平的平均改善幅度为16%至48%，爆发性SCS组为16%至17%，传统药物治疗组为-15%至16%，假手术组为10%至16%。强直性SCS组在6个月时功能的平均改善幅度为21%至45%，而传统药物治疗组为0%至21%。这些研究中报告的不良事件包括电极移位（10%-14%）、植入式脉冲发生器（IPG）部位疼痛（1%-12%）、感染（6.9%-10%）和硬膜穿刺（6%）。Cochrane偏倚风险评估显示，三分之一的纳入研究风险较低，而超过一半的研究存在一些问题。根据GRADE系统，基于现有的RCT，总体上有中等质量的证据表明，SCS在6个月时对减轻PSPS-T2患者的疼痛和残疾具有临床有效性。
讨论/结论：与传统药物治疗相比，相当比例的患者在强直性SCS治疗6个月后疼痛缓解≥50%，显示出临床有效性。在强直性SCS治疗后3至24个月的研究终点观察到功能和生活质量有显著改善。本综述中纳入的研究均未使用更新的、可能更有效的SCS技术，如闭环、高频或多波形SCS。唯一纳入的假手术对照研究未证明爆发性SCS的疗效。不同研究报告的不良事件发生率，包括感染和植入部位疼痛，差异显著，较新的研究和较旧的研究分别代表了这些范围的下限和上限。
