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前瞻性研究使用 10 kHz 脊髓刺激治疗持续性未手术的神经源性低位腰痛的一年结果:首次背部研究。

One-Year Results of Prospective Research Study Using 10 kHz Spinal Cord Stimulation in Persistent Nonoperated Low Back Pain of Neuropathic Origin: Maiden Back Study.

机构信息

Leeds Teaching Hospitals NHS Trust, Leeds, UK.

School of Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, UK.

出版信息

Neuromodulation. 2021 Apr;24(3):479-487. doi: 10.1111/ner.13345. Epub 2020 Dec 22.

DOI:10.1111/ner.13345
PMID:33351230
Abstract

PURPOSE

Spinal cord stimulation (SCS) is a recommended treatment for chronic neuropathic pain. Persistent nonoperative low back pain of neuropathic origin has profound negative impacts on patient's lives. This prospective, open label, research study aimed to explore the use of SCS in patients with associated features of central sensitisation such as allodynia and hyperalgesia.

MATERIALS AND METHODS

Twenty-one patients with back pain and hyperalgesia or allodynia who had not had prior spinal surgery underwent a SCS trial followed by full implantation. SCS comprised administering electrical impulses epidurally at a frequency of 10 kHz and pulse width of 30 μsec. Patients attended follow-up visits after 6 and 12 months of SCS. Repeated measure ANOVAs/Friedman tests explored change after 6 and 12 months of 10 kHz SCS. Independent sample t-tests/Mann-Whitney U tests examined differences in response after 12 months of 10 kHz SCS.

RESULTS

Back and leg pain, quality of life (QoL), pain-related disability, and morphine equivalence significantly improved compared with baseline following 6 and 12 months of 10 kHz SCS. There were no increases in the consumption of opioids, amitriptyline, gabapentin or pregabalin in any patient. After 12 months of treatment, 52% encountered ≥50% improvement in back pain, 44% achieved remission (0-3 cm back pain VAS), 40% reported ODI scores between 0 and 40 and 60% experienced a reduction of at least 10 ODI points. Patients reporting ≥10-point improvement in ODI had significantly longer pain history durations and experienced significantly greater improvements in back pain, leg pain and QoL than those reporting <10-point improvement in ODI.

CONCLUSION

The 10 kHz SCS improved back and leg pain, QoL, pain-related disability and medication consumption in patients with nonoperative back pain of neuropathic origin. With further research incorporating a sham control arm, the efficacy of 10 kHz SCS in this patient cohort will become more established.

摘要

目的

脊髓刺激(SCS)是治疗慢性神经性疼痛的推荐疗法。神经性起源的持续性非手术性腰痛对患者的生活有深远的负面影响。本前瞻性、开放标签、研究旨在探讨 SCS 在伴有中央敏化特征(如痛觉过敏和感觉异常)的患者中的应用。

材料和方法

21 例腰痛伴痛觉过敏或感觉异常且无脊柱手术史的患者进行了 SCS 试验,随后进行了全面植入。SCS 包括在 10 kHz 频率和 30μsec 脉冲宽度下进行硬膜外电脉冲刺激。患者在 SCS 后 6 个月和 12 个月进行随访。重复测量方差分析/Friedman 检验探索了 10 kHz SCS 后 6 个月和 12 个月的变化。独立样本 t 检验/曼-惠特尼 U 检验检查了 10 kHz SCS 后 12 个月时反应的差异。

结果

与基线相比,10 kHz SCS 后 6 个月和 12 个月时,背部和腿部疼痛、生活质量(QoL)、与疼痛相关的残疾和吗啡当量均显著改善。没有患者增加阿片类药物、阿米替林、加巴喷丁或普瑞巴林的用量。治疗 12 个月后,52%的患者背部疼痛改善≥50%,44%达到缓解(0-3 cm 背部疼痛 VAS),40%报告 ODI 评分在 0 至 40 之间,60%的 ODI 评分降低至少 10 分。报告 ODI 改善≥10 分的患者疼痛史持续时间明显更长,背部疼痛、腿部疼痛和 QoL 改善明显大于报告 ODI 改善<10 分的患者。

结论

10 kHz SCS 改善了非手术性神经性起源腰痛患者的背部和腿部疼痛、生活质量、与疼痛相关的残疾和药物使用。随着进一步的研究纳入假手术对照臂,10 kHz SCS 在这一患者群体中的疗效将得到更确定。

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