Mehta Vivek, Poply Kavita, Ahmad Alia, Lascelles Joanne, Elyas Amin, Sharma Sanskriti, Ganeshan Balaji, Ellamushi Habib, Nikolic Serge
Pain Research Centre, St Bartholomew's Hospital & Royal London Hospital, London, UK.
Barts Neuromodulation Centre St Bartholomew's Hospital & Royal London Hospital, London, UK.
Pain Pract. 2022 Feb;22(2):233-247. doi: 10.1111/papr.13087. Epub 2021 Nov 14.
Spinal cord stimulation (SCS) is being increasingly used in non-surgical intractable low back pain. This study was designed to evaluate the efficacy of high-dose (HD) SCS utilizing sub-perception stimulation with higher frequency and pulse width in non-surgical predominant low-back pain population at 12 months.
A total of 20 patients were recruited (280 screened between March 2017 and July 2018) to undergo percutaneous fluoroscopic-guided SCS (Medtronic 8 contact standard leads and Restore IPG), with T8 and T9 midline anatomical parallel placement. Sixteen patients completed 12 months follow-up (500 Hz frequency, 500 μs pulse width, and 25% pulse density). Differences in patients' clinical outcome (NRS back, NRS leg, ODI, PGIC, and PSQ) and medication usage (MQS) at 1, 3, and 12 months from the baseline were assessed using non-parametric Wilcoxon paired test.
The mean NRS scores for back pain (baseline 7.53) improved significantly at 1, 3, and 12 months; 2.78 (p < 0.001), 4.45 (p = 0.002), and 3.85 (p = 0.002), respectively. The mean NRS score for leg pain (baseline 6.09) improved significantly at 1 and 3 months; 1.86 (p < 0.001) and 3.13 (p = 0.010), respectively. Mean NRS for leg pain at 12 months was 3.85 (p = 0.057). ODI and sleep demonstrated significant improvement as there was consistent improvement in medication particularly opioid usage (MQS) at 12 months.
This study demonstrates that anatomical placement of leads with sub-perception HD stimulation could provide effective pain relief in patients who are not candidates for spinal surgery.
脊髓刺激（SCS）在非手术治疗的顽固性腰痛中的应用越来越广泛。本研究旨在评估高剂量（HD）SCS在非手术为主的腰痛人群中，采用更高频率和脉宽的亚感知刺激在12个月时的疗效。
共招募20例患者（2017年3月至2018年7月期间筛选了280例）接受经皮荧光镜引导下的SCS（美敦力8触点标准导联和Restore IPG），T8和T9中线解剖平行放置。16例患者完成了12个月的随访（频率500Hz，脉宽500μs，脉冲密度25%）。使用非参数Wilcoxon配对检验评估患者在基线后1、3和12个月时的临床结局（背部NRS、腿部NRS、ODI、PGIC和PSQ）和药物使用情况（MQS）的差异。
背痛的平均NRS评分（基线7.53）在1、3和12个月时显著改善；分别为2.78（p<0.001）、4.45（p = 0.002）和3.85（p = 0.002）。腿部疼痛的平均NRS评分（基线6.09）在1和3个月时显著改善；分别为1.86（p<0.001）和3.13（p = 0.010）。12个月时腿部疼痛的平均NRS为3.85（p = 0.057）。ODI和睡眠有显著改善，因为在12个月时药物使用，尤其是阿片类药物的使用（MQS）持续改善。
本研究表明，采用亚感知HD刺激的导联解剖放置可为不适合脊柱手术的患者提供有效的疼痛缓解。
