Salmon John, Bates Dan, Du Toit Neels, Verrills Paul, Yu James, Taverner Murray G, Mohabbati Vahid, Green Matthew, Heit Gary, Levy Robert, Staats Peter, Ruais Jonathan, Kottalgi Shilpa, Makous James, Mitchell Bruce
Pain Care Perth and Western Australia, Pain Management, Perth, Western Australia, Australia.
Metro Pain Group, Pain Management, Melbourne, Victoria, Australia.
Neuromodulation. 2023 Jan;26(1):172-181. doi: 10.1016/j.neurom.2022.11.002.
A novel, spinal cord stimulation (SCS) system with a battery-free miniaturized implantable pulse generator (IPG) was used in this feasibility study. The system uses an external power source that communicates bidirectionally with the IPG (< 1.5 cm). Human factors, subject comfort, and effects on low back and leg pain were evaluated in this first-in-human study.
A prospective, multicenter, open-label clinical trial was initiated to evaluate the safety and performance of a novel miniaturized stimulator in the treatment of chronic, intractable leg and low-back pain. Eligible subjects were recruited for the study and gave consent. Subjects who passed the screening/trial phase (defined as ≥ 50% decrease in pain) continued to the long-term implant phase and were followed up at predefined time points after device activation. Interim clinical and usability outcomes were captured and reported at 90 days.
Results of 22 subjects who chose a novel pulsed stimulation pattern therapy using the battery-free IPG (< 1.5 cm) are described here. At 90-days follow-up, the average pain reduction was 79% in the leg (n = 22; p < 0.0001) and 76% in the low back (n = 21; p < 0.0001) compared with baseline. Responder rates (≥ 50% pain relief) at 90 days were 86% in leg pain (19/22) and 81% in low-back pain (17/21). Subjects rated the level of comfort of the external wearable power source to be 0.41 ± 0.73 at 90 days on an 11-point rating scale (0 = very comfortable, 10 = very uncomfortable).
These interim results from the ongoing study indicate the favorable efficacy and usability of a novel, externally powered, battery-free SCS IPG (< 1.5 cm) for leg and low-back pain. Study subjects wore the external power source continuously and found it comfortable, and the system provided significant pain relief. These preliminary findings warrant further investigation.
The Clinicaltrials.gov registration number for the study is ACTRN12618001862235.
在本可行性研究中使用了一种新型的脊髓刺激（SCS）系统，该系统配备无电池的小型化植入式脉冲发生器（IPG）。该系统使用与IPG（<1.5厘米）进行双向通信的外部电源。在这项首次人体研究中评估了人为因素、受试者舒适度以及对腰腿痛的影响。
启动了一项前瞻性、多中心、开放标签的临床试验，以评估新型小型化刺激器治疗慢性顽固性腿痛和腰痛的安全性和性能。招募符合条件的受试者参与研究并获得其同意。通过筛选/试验阶段（定义为疼痛减轻≥50%）的受试者进入长期植入阶段，并在设备激活后的预定时间点进行随访。在90天时收集并报告中期临床和可用性结果。
这里描述了22名选择使用无电池IPG（<1.5厘米）进行新型脉冲刺激模式治疗的受试者的结果。在90天随访时，与基线相比，腿部平均疼痛减轻79%（n = 22；p < 0.0001），腰部平均疼痛减轻76%（n = 21；p < 0.0001）。90天时的缓解率（疼痛缓解≥50%）在腿痛患者中为86%（19/22），在腰痛患者中为81%（17/21）。在11分制评分量表（0 = 非常舒适，10 = 非常不舒适）上，受试者在90天时对外部可穿戴电源舒适度的评分为0.41±0.73。
这项正在进行的研究的这些中期结果表明，一种新型的、外部供电的、无电池的SCS IPG（<1.5厘米）对腿痛和腰痛具有良好的疗效和可用性。研究受试者持续佩戴外部电源并感觉舒适，并且该系统提供了显著的疼痛缓解。这些初步发现值得进一步研究。
该研究在Clinicaltrials.gov上的注册号为ACTRN12618001862235。
