Carolinas Pain Institute, Winston-Salem, NC, USA.
Nevada Advanced Pain Specialists, Reno, NV, USA.
Neuromodulation. 2023 Oct;26(7):1400-1411. doi: 10.1016/j.neurom.2023.05.006. Epub 2023 Aug 16.
This study aimed to assess the safety and effectiveness of a new charge-distributed multiphase stimulation paradigm during an extended spinal cord stimulation (SCS) trial.
This prospective, multicenter, randomized, single-blind, feasibility study included participants with chronic low back and/or leg pain and baseline numerical rating scale (NRS) for overall pain intensity ≥6. After a successful commercial SCS trial, participants were randomized to multiphase SCS therapy A (approximately 600-1500 Hz) or B (approximately 300-600 Hz), delivered via an investigational external pulse generator and existing leads during an 11-to-12-day testing period. Primary end points were mean NRS change from baseline to final in-office visit for each multiphase therapy and between therapies. Secondary end points included mean NRS change from end of commercial trial to final study visit and incidence of device-related adverse events (AEs). Additional measures included patient-reported outcomes collected at home through electronic watches and written diaries. Power usage was compared between multiphase and commercial therapies.
A total of 122 participants initiated a commercial trial; 77 were randomized to a multiphase arm, and 65 completed the study. Reductions in mean NRS scores from baseline to final study visit were significant for multiphase therapy A and B (-4.3 and -4.7, respectively; both p < 0.0001). There was no statistically significant difference in mean NRS reduction or percent pain relief between multiphase therapies. In an additional analysis, 63.9% of participants reported greater pain relief with multiphase than with commercial SCS therapy in the at-home setting. On average, multiphase required less power than did commercial devices. One non-serious device-related AE was reported, and no infections occurred during the extended trial.
Multiphase SCS effectively reduced pain in participants with chronic low back and/or leg pain during a trial, with no unanticipated device-related AEs reported. Future studies should evaluate long-term effectiveness of multiphase stimulation.
The Clinicaltrials.gov registration number for the study is NCT03594266.
本研究旨在评估一种新的电荷分布多相刺激模式在延长脊髓刺激（SCS）试验中的安全性和有效性。
这项前瞻性、多中心、随机、单盲、可行性研究纳入了慢性腰痛和/或腿痛且基线总体疼痛强度数字评定量表（NRS）≥6 的患者。在成功进行商业 SCS 试验后，患者被随机分配至多相 SCS 治疗 A（约 600-1500 Hz）或 B（约 300-600 Hz），通过研究用外部脉冲发生器和现有的导线在 11-12 天的测试期内进行治疗。主要终点是每种多相治疗和治疗之间从基线到最终门诊就诊的平均 NRS 变化。次要终点包括从商业试验结束到最终研究就诊的平均 NRS 变化以及与设备相关的不良事件（AE）的发生率。其他措施包括通过电子手表和书面日记在家中收集的患者报告结果。比较了多相和商业治疗之间的功耗。
共有 122 名患者开始进行商业试验；77 名患者被随机分配至多相组，65 名患者完成了研究。多相治疗 A 和 B 的平均 NRS 评分从基线到最终研究就诊时均显著降低（分别为-4.3 和-4.7，均<0.0001）。多相治疗之间的平均 NRS 降低或疼痛缓解百分比无统计学差异。在额外的分析中，63.9%的参与者报告在家庭环境中多相治疗比商业 SCS 治疗更能缓解疼痛。平均而言，多相治疗比商业设备需要的功率更少。报告了 1 例非严重与设备相关的 AE，在延长试验期间未发生感染。
多相 SCS 在慢性腰痛和/或腿痛患者的试验中有效减轻了疼痛，且未报告意外的与设备相关的 AE。未来的研究应评估多相刺激的长期效果。
该研究的 Clinicaltrials.gov 注册号为 NCT03594266。
