International Spine, Pain & Performance Center, Washington, DC; George Washington University, School of Medicine & Health Sciences, Washington, DC.
Virginia Interventional Pain & Spine Center, Christiansburg, VA.
Pain Physician. 2023 Nov;26(7):575-584.
Chronic, intractable, neuropathic pain is readily treatable with spinal cord stimulation (SCS). Technological advancements, including device miniaturization, are advancing the field of neuromodulation.
We report here the results of an SCS clinical trial to treat chronic, low back and leg pain, with a micro-implantable pulse generator (micro-IPG).
This was a single-arm, prospective, multicenter, postmarket, observational study.
Patients were recruited from 15 US-based comprehensive pain centers.
This open-label clinical trial was designed to evaluate the performance of the Nalu™ Neurostimulation System (Nalu Medical, Inc., Carlsbad, CA) in the treatment of low back and leg pain. Patients, who provided informed consent and were successfully screened for study entry, were implanted with temporary trial leads. Patients went on to receive a permanent implant of the leads and micro-IPG if they demonstrated a >= 50% reduction in pain during the temporary trial period. Patient-reported outcomes (PROs), such as pain scores, functional disability, mood, patient impression of change, comfort, therapy use profile, and device ease of use, were captured.
At baseline, the average pain Visual Analog Scale (VAS) score was 72.1 ± 17.9 in the leg and 78.0 ± 15.4 in the low back. At 90 days following permanent implant (end of study), pain scores improved by 76% (VAS 18.5 ± 18.8) in the leg and 75% (VAS 19.7 ± 20.8) in the low back. Eighty-six percent of both leg pain and low back pain patients demonstrated a >= 50% reduction in pain at 90 days following implant. The comfort of the external wearable (Therapy Disc and Adhesive Clip) was rated 1.16 ± 1.53, on average, at 90 days on an 11-point rating scale (0 = very comfortable, 10 = very uncomfortable). All PROs demonstrated statistically significant symptomatic improvement at 90 days following implant of the micro-IPG.
Limitations of this study include the lack of long-term results (beyond 90 days) and a relatively small sample size of 35 patients who were part of the analysis; additionally, there was no control arm or randomization as this was a single-arm study, without a comparator, designed to document the efficacy and safety of the device. Therefore, no direct comparisons to other SCS systems were possible.
This clinical study demonstrated profound leg and low back pain relief in terms of overall pain reduction, as well as the proportion of therapy responders. The study patients reported the wearable aspects of the system to be very comfortable.
慢性、顽固性、神经性疼痛可以通过脊髓刺激（SCS）很好地治疗。技术的进步，包括设备的小型化，正在推动神经调节领域的发展。
我们在此报告一项 SCS 临床试验的结果，该试验旨在使用微植入脉冲发生器（micro-IPG）治疗慢性下腰痛。
这是一项单臂、前瞻性、多中心、上市后、观察性研究。
患者从 15 家美国综合性疼痛中心招募。
这项开放性临床试验旨在评估 Nalu™神经刺激系统（Nalu Medical，Inc.，加利福尼亚州卡尔斯巴德）在治疗下腰痛方面的性能。患者在知情同意并成功筛选入组后，被植入临时试验导线。如果在临时试验期间疼痛减轻≥50%，患者将接受导线和微 IPG 的永久性植入。在 90 天的永久性植入后（研究结束时），使用疼痛评分、功能障碍、情绪、患者对变化的印象、舒适度、治疗使用情况和设备易用性等患者报告的结果（PROs）进行评估。
在基线时，腿部的平均疼痛视觉模拟量表（VAS）评分为 72.1±17.9，下背部为 78.0±15.4。在永久性植入后 90 天（研究结束时），腿部疼痛评分改善了 76%（VAS 18.5±18.8），下背部疼痛评分改善了 75%（VAS 19.7±20.8）。86%的腿部疼痛和下背部疼痛患者在植入后 90 天疼痛减轻≥50%。外部可穿戴设备（治疗盘和粘性夹）的舒适度在 90 天时平均评分为 1.16±1.53，采用 11 分评分量表（0=非常舒适，10=非常不适）。在永久性植入微 IPG 后 90 天，所有 PROs 均显示出统计学上显著的症状改善。
本研究的局限性包括缺乏长期结果（90 天以上）和仅有 35 名患者的样本量相对较小，这些患者参与了分析；此外，由于这是一项无对照组或随机分组的单臂研究，旨在记录设备的疗效和安全性，因此没有直接比较其他 SCS 系统的可能性。
这项临床研究显示出腿部和下腰痛在总体疼痛减轻方面的显著缓解，以及治疗反应者的比例。研究患者报告说，系统的可穿戴部分非常舒适。
