Deer Timothy, Heros Robert, Tavel Edward, Wahezi Sayed, Funk Robert, Buchanan Patrick, Christopher Anne, Weisbein Jacqueline, Gilligan Christopher, Patterson Denis, Antony Ajay, Ibrahim Mohab, Miller Nathan, Scarfo Keith, Johnson Gayle, Panchalingam Thadchaigeni, Okaro Udoka, Yue James
Pain Management, The Spine and Nerve Center of the Virginias, Charleston, WV, USA.
Pain Management, Spinal Diagnostics, Tualatin, OR, USA.
J Pain Res. 2024 Aug 23;17:2741-2752. doi: 10.2147/JPR.S472481. eCollection 2024.
Low Back Pain (LBP) is a prevalent condition. Spinal cord stimulation (SCS) has emerged as a more effective, long-term treatment compared to conventional medical management (CMM). The DISTINCT study enrolled and randomized chronic LBP patients with no indication of traditional spine surgery. This analysis focuses comparing study outcomes on patients initially randomized to receive CMM treatment and subsequently crossed over to SCS after 6 months.
To compare the therapeutic effectiveness and cost-efficiency of passive recharge burst SCS to CMM.
A total of 269 patients were enrolled with 162 randomly assigned to SCS and 107 to CMM. The DISTINCT study design allowed a crossover to the alternative treatment arm after 6 months. Patients underwent a trial and received a permanent implant if they reported ≥50% pain reduction. Outcome analysis included pain (NRS), disability (ODI), catastrophizing (PCS), quality of life (PROMIS-29) and health care utilization.
Seventy out of eighty-one patients opted to cross over to trial SCS at 6M with 94% (66/70) undergoing a trial. Among those, 88% (58/66) reported a ≥50% or more pain relief and 55 received a permanent implant. At 12M visit, 71.4% reported a ≥50% pain improvement sustained at the 18M visit, with 24.5% (12/49) indicating a ≥80% improvement. Disability reductions (79% meeting the minimally important difference of a 13-point decrease), decreased catastrophizing, and significant improvements in all PROMIS-29 domains were noted. Furthermore, 42% of the patients reported decreased or discontinued opioid usage. Clinical benefits at the 12M visit were sustained through the 18M visit accompanied by a significant reduction in healthcare utilization and a $1214 cost savings.
SCS demonstrates superior, long-term performance and safety outcomes compared to CMM therapy in LBP patients who received both CMM and SCS therapy. Additionally, SCS patients experienced reduced healthcare resource utilization and lower costs compared to those receiving CMM.
腰痛（LBP）是一种常见病症。与传统药物治疗（CMM）相比，脊髓刺激（SCS）已成为一种更有效的长期治疗方法。DISTINCT研究纳入并随机分配了无传统脊柱手术指征的慢性LBP患者。本分析重点比较最初随机接受CMM治疗、6个月后转而接受SCS治疗的患者的研究结果。
比较被动充电式脉冲SCS与CMM的治疗效果和成本效益。
共纳入269例患者，162例随机分配至SCS组，107例分配至CMM组。DISTINCT研究设计允许患者在6个月后交叉至另一治疗组。患者接受试验，若报告疼痛减轻≥50%，则接受永久性植入。结果分析包括疼痛（数字评分量表[NRS]）、功能障碍（Oswestry功能障碍指数[ODI]）、灾难化思维（疼痛灾难化量表[PCS]）、生活质量（患者报告结果测量信息系统-29[PROMIS-29]）和医疗保健利用情况。
81例患者中有70例在6个月时选择交叉至SCS试验组，其中94%（66/70）接受了试验。在这些患者中，88%（58/66）报告疼痛减轻≥50%或更多，55例接受了永久性植入。在12个月随访时，71.4%的患者报告疼痛改善≥50%并持续至18个月随访时，24.5%（12/49）的患者疼痛改善≥80%。观察到功能障碍减轻（79%达到最小重要差异即降低13分）、灾难化思维减少以及PROMIS-29所有领域均有显著改善。此外，42%的患者报告阿片类药物使用减少或停用。12个月随访时的临床获益持续至18个月随访时，同时医疗保健利用显著减少，节省成本1214美元。
在接受过CMM和SCS治疗的LBP患者中，与CMM治疗相比，SCS显示出更优的长期性能和安全性结果。此外，与接受CMM治疗的患者相比，接受SCS治疗的患者医疗资源利用减少且成本更低。
