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10kHz高频脊髓刺激治疗无脊柱手术史患者的慢性轴性下腰痛:一项初步、前瞻性、开放标签的概念验证研究。

10 kHz High-Frequency Spinal Cord Stimulation for Chronic Axial Low Back Pain in Patients With No History of Spinal Surgery: A Preliminary, Prospective, Open Label and Proof-of-Concept Study.

作者信息

Al-Kaisy Adnan, Palmisani Stefano, Smith Thomas E, Pang David, Lam Khai, Burgoyne William, Houghton Russell, Hudson Emma, Lucas Jonathan

机构信息

Guys and St Thomas' NHS Trust, Consultant in Pain Medicine, London, UK.

Consultant Orthopaedic and Spinal Surgeon, Guys and St Thomas' NHS Trust, London, UK.

出版信息

Neuromodulation. 2017 Jan;20(1):63-70. doi: 10.1111/ner.12563. Epub 2016 Dec 26.

DOI:10.1111/ner.12563
PMID:28025843
Abstract

OBJECTIVE

To explore the effectiveness of 10 kHz high frequency spinal cord stimulation (HF10 therapy) treatment of chronic low back pain in patients who have not had spinal surgery.

METHODS

Patients with chronic low back pain without prior spinal surgery were evaluated by a team of spine surgeons to rule out any spinal pathology amenable to surgical interventions and by a multidisciplinary pain team to confirm eligibility for the study. After a successful (>50% back pain reduction) trial of HF10 therapy, enrolled subjects underwent permanent system implantation and were followed-up one year post-implant.

RESULTS

About 95% of the enrolled subjects (20/21) received the permanent system. At 12 months post-implant, both back pain VAS score and ODI were significantly reduced compared with baseline values (by 73% and 48%, respectively); an estimated quality-adjusted life year gain of 0.47 and a reduction in opioid use by 64% was observed. Four more patients among those unable to work at baseline due to back pain were employed at 12 months post-implant. There were no serious adverse events.

CONCLUSION

HF10 therapy may provide significant back pain relief, reduction in disability, improvement quality of life, and reduction in opioid use in chronic low back pain not resulting from spinal surgery.

摘要

目的

探讨10kHz高频脊髓刺激(HF10疗法)对未接受过脊柱手术的慢性下腰痛患者的治疗效果。

方法

由一组脊柱外科医生对未接受过脊柱手术的慢性下腰痛患者进行评估,以排除任何适合手术干预的脊柱病变,并由多学科疼痛治疗团队确认其符合研究条件。在HF10疗法试验成功(背痛减轻>50%)后,入组受试者接受永久性系统植入,并在植入后随访一年。

结果

约95%的入组受试者(20/21)接受了永久性系统。植入后12个月,背痛视觉模拟评分(VAS)和Oswestry功能障碍指数(ODI)均较基线值显著降低(分别降低73%和48%);估计质量调整生命年增益为0.47,阿片类药物使用量减少64%。在植入后12个月时,另外4名在基线时因背痛无法工作的患者恢复了工作。未发生严重不良事件。

结论

HF10疗法可能为非脊柱手术引起的慢性下腰痛患者提供显著的背痛缓解、功能障碍减轻、生活质量改善及阿片类药物使用减少。

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