Millennium Pain Center, Bloomington, IL.
Pain Care, LLC, Stockbridge, GA.
Pain Physician. 2020 Jan;23(1):87-98.
Therapeutic approaches to spinal cord stimulation (SCS) continue to evolve and improve patient outcomes in patients receiving SCS therapy secondary to failed back surgery syndrome.
The aim of this study was to evaluate pain relief and other patient outcomes of SCS using selected high-dose programming parameters.
This was a prospective cohort study.
This study took place at 11 centers in North America.
Forty-four SCS-naive patients underwent trialing, starting with 1,000 Hz frequency, 90 µs pulse width followed by 300 Hz frequency, 800 µs pulse width, if pain relief was inadequate. Patients with 50% or greater pain relief were eligible for permanent implantation. Patient's pain rating, global impression of change, health-related quality of life, functional disability, satisfaction/recommendation, stimulation perception, device programming, and adverse events were assessed at 3 months postimplant.
There were significant improvements from baseline in mean Numeric Rating Scale (NRS-11) pain scores for overall pain (7.5 to 3.8; P < 0.01), back pain (7.2 to 3.4; P < 0.01), leg pain (7.2 to 3.1; P < 0.01), Oswestry Disability Index (ODI) score (51.5 to 32.1; P < 0.01), and European Quality of Life-Five Dimensions, version 5L score (EQ-5D-5L) (0.58 to 0.74; P < 0.01). Twenty-eight of 32 patients (88%) had significant, favorable improvement in Patient Global Impression of Change (PGIC). Eighty-four percent of patients were "satisfied," and 78.1% would "definitely" recommend SCS. Eighteen patients (56%) used 1,000 Hz frequency and 90 µs pulse width exclusively; these patients experienced mean NRS-11 overall pain score improvement of 4.7 points. Device-, therapy-, or procedure-related adverse events were experienced in 19 patients (40%, 19 of 48), and all events resolved without reoperation and were similar to those observed with traditional SCS systems.
There was no active or sham comparator group, and therefore the reported effects may not be solely attributable to therapy effects and may be related to other, nonspecific effects of SCS.
Improvements in pain relief, PGIC, EQ-5D-5L, ODI, and patient satisfaction were all clinically relevant and statistically significant. Future studies are needed to understand how these high-dose parameters perform versus a standard comparator.
Spinal cord stimulation, high-frequency electrical stimulation, failed back surgery syndrome, neurostimulation, prospective, nonrandomized study.
脊髓刺激（SCS）的治疗方法不断发展，为接受 SCS 治疗的患者带来了更好的疗效，这些患者由于失败的腰椎手术综合征而出现疼痛。
本研究旨在评估使用选定的高剂量编程参数的 SCS 的疼痛缓解和其他患者结局。
这是一项前瞻性队列研究。
这项研究在北美 11 个中心进行。
44 名 SCS 初治患者接受了试验，起始频率为 1000 Hz，脉冲宽度为 90 μs，如果疼痛缓解不足，则使用 300 Hz，脉冲宽度为 800 μs。如果疼痛缓解达到 50%或更高，患者就有资格进行永久性植入。在植入后 3 个月评估患者的疼痛评分、总体变化印象、健康相关生活质量、功能障碍、满意度/推荐、刺激感知、设备编程和不良事件。
与基线相比，总体疼痛（NRS-11）评分（7.5 至 3.8；P < 0.01）、背部疼痛（7.2 至 3.4；P < 0.01）、腿部疼痛（7.2 至 3.1；P < 0.01）、Oswestry 残疾指数（ODI）评分（51.5 至 32.1；P < 0.01）和欧洲生活质量五维量表（EQ-5D-5L）评分（0.58 至 0.74；P < 0.01）均有显著改善。32 名患者中有 28 名（88%）的患者总体变化印象（PGIC）有显著改善。84%的患者“满意”，78.1%的患者“肯定”推荐 SCS。18 名患者（56%）仅使用 1000 Hz 频率和 90 μs 脉冲宽度；这些患者的 NRS-11 总体疼痛评分改善了 4.7 分。19 名患者（40%，19 例/48 例）经历了与设备、治疗或程序相关的不良事件，所有不良事件均无需再次手术即可解决，且与传统 SCS 系统观察到的不良事件相似。
没有活性或假对照组，因此报告的效果可能不仅仅归因于治疗效果，还可能与 SCS 的其他非特异性效果有关。
疼痛缓解、PGIC、EQ-5D-5L、ODI 和患者满意度的改善均具有临床意义和统计学意义。未来需要进一步的研究来了解这些高剂量参数与标准对照相比的表现。
脊髓刺激，高频电刺激，失败的腰椎手术综合征，神经刺激，前瞻性，非随机研究。
