Evolve Restorative Center, California Society of Interventional Pain Society, Santa Rosa, CA, USA.
Sana Kliniken Duisburg, Duisburg, Germany.
Neuromodulation. 2020 Jan;23(1):109-117. doi: 10.1111/ner.13019. Epub 2019 Jul 19.
The purpose of this study was to compare the trial success rate between anatomic lead placement (AP) and paresthesia-mapped (PM) lead placement techniques for spinal cord stimulation (SCS) using a nonlinear burst stimulation pattern.
Eligible patients with back and/or leg pain with a Numeric Rating Scale (NRS) score of ≥6 who had not undergone previous SCS were enrolled in the study. A total of 270 patients were randomized in a 1:1 ratio to each treatment arm. In the AP group, one lead tip was placed at the mid-body of T8, and the other at the superior endplate of T9. In the PM group, physicians confirmed coverage of the patient's primary pain location. Trial success was a composite of the following: ≥50% patient-reported pain relief at the end of the minimum three-day trial period, physician's recommendation, and patient's interest in a permanent implant.
Trial success for AP vs. PM groups was equivalent to 84.4% and 82.3%, respectively. Physicians who performed both techniques preferred AP technique (70% vs. 30%). Procedure times for placement of two leads were 31% shorter in the AP group (p < 0.0001). Decrease in the mean NRS pain score was similar between groups (53.2%, AP group; 53.8%, PM group, p = 0.79). Trial success for patients who went on to an extended trial with tonic stimulation was 50% (5/10) vs. 79% (11/14) for AP group and PM group, respectively (p = 0.2). A total of 13 adverse events were observed (4.5%), most commonly lead migrations and pain around implant site, with no difference between groups.
When using a nonlinear burst stimulation pattern, anatomic or PM lead placement technique may be used. Nonresponders to subthreshold stimulation had a higher conversion rate when a PM technique was used. AP resulted in shorter procedure times with a similar safety profile and was strongly preferred by trialing physicians.
本研究旨在比较使用非线性爆发刺激模式时解剖置管（AP）和感觉映射置管（PM）技术在脊髓刺激（SCS）中的试验成功率。
纳入未接受过 SCS 的背痛和/或腿痛且数字评分量表（NRS）评分≥6 的合格患者，将其随机分为两组，每组 135 例。AP 组中，一根导丝尖端置于 T8 体中部，另一根置于 T9 上终板。PM 组中，医生确认覆盖患者的主要疼痛部位。试验成功的综合标准包括：在最短 3 天试验期结束时，患者报告疼痛缓解≥50%、医生建议和患者对永久植入物感兴趣。
AP 组和 PM 组的试验成功率分别为 84.4%和 82.3%。同时进行这两种技术的医生更倾向于 AP 技术（70%比 30%）。AP 组的两根导丝放置时间缩短 31%（p<0.0001）。两组的平均 NRS 疼痛评分下降相似（AP 组 53.2%，PM 组 53.8%，p=0.79）。进行强直刺激扩展试验的患者中，AP 组和 PM 组的试验成功率分别为 50%（5/10）和 79%（11/14）（p=0.2）。观察到 13 例不良事件（4.5%），最常见的是导丝移位和植入部位周围疼痛，两组间无差异。
使用非线性爆发刺激模式时，可采用解剖或 PM 导丝放置技术。对阈下刺激无反应的患者，使用 PM 技术时转化率更高。AP 技术可缩短手术时间，安全性相似，且受到试用医生的强烈青睐。
