ECAP-controlled Closed-loop Spinal Cord Stimulation for Chronic Non-surgical Refractory Back Pain: Subgroup Analysis from Two Prospective Multicenter Clinical Trials.

IF 2.6 2区医学 Q2 CLINICAL NEUROLOGY

Spine Pub Date : 2025-07-01 DOI:10.1097/BRS.0000000000005445

Corey W Hunter, Jeffrey S Raskin, Nagy A Mekhail, Erika A Petersen, Shivanand P Lad, Jason E Pope, Shrif J Costandi, Leonardo Kapural, Ronald B Boeding, Ajay Antony, Steven M Rosen, Robert D Heros, Dawood Sayed, Sean Li, Ahmed M Raslan, G Lawson Smith, Johnathan H Goree, Angela Leitner, Nicole Soliday, Rui V Duarte, Timothy R Deer

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引用次数: 0

Abstract

Study design: Subgroup analysis of patients with chronic non-surgical refractory back pain (NSRBP) from two prospective multicenter clinical trials to 12-month follow-up.

Objective: To evaluate pain-related and holistic response, safety events as well as neurophysiologic metrics associated with the use of evoked compound action potential (ECAP)-controlled closed-loop spinal cord stimulation (SCS) for patients with chronic back pain without prior surgery.

Summary of background data: Innovations in SCS such as the development of physiologic ECAP-controlled closed-loop SCS overcome limitations of traditional, fixed-output SCS for the treatment of NSRBP. The outcomes of closed-loop SCS to 12-month follow-up for patients with NSRBP have not been previously reported.

Methods: Patient-reported outcome measures for pain intensity, physical function, health-related quality of life, sleep quality and emotional function were collected from 68 patients with NSRBP in two prospective multicenter clinical trials. Change in opioid use, its reduction or elimination were assessed at 12-month follow-up. A validated composite outcome measure comprising the different health domains was used to evaluate holistic treatment response through minimal clinically important differences (MCIDs). Objective device metrics provide information on system utilization, loop performance (dose accuracy), and neurophysiologic dose metrics.

Results: At 12-months, 79% of patients reported ≥50% reduction in pain intensity and 48% obtained ≥80% pain relief. Significant improvements in all patient-reported outcome measures assessed were observed at 3- and 12-months. Voluntary reduction or elimination of opioid use was observed in approximately half of the patients that were taking opioids at baseline. System utilization was >80%, dose ratio was >1.3 (i.e., 30% above ECAP threshold) with a high dose accuracy keeping the elicited ECAP within 3.5 μV of the target ECAP set on the system.

Conclusion: ECAP-controlled closed-loop SCS represents a safe and effective treatment option for patients with NSRBP.

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ecap控制的闭环脊髓刺激治疗慢性非手术性难治性背痛：两项前瞻性多中心临床试验的亚组分析

研究设计：对两项前瞻性多中心临床试验中慢性非手术性难治性背痛（NSRBP）患者进行亚组分析，随访12个月。目的：评估未经手术治疗的慢性背痛患者使用诱发复合动作电位（ECAP）控制的闭环脊髓刺激（SCS）的疼痛相关反应、整体反应、安全事件以及神经生理指标。背景资料总结：生理性ecap控制的闭环SCS的发展等SCS的创新克服了传统固定输出SCS治疗NSRBP的局限性。对NSRBP患者进行闭环SCS至12个月随访的结果此前未见报道。方法：在两项前瞻性多中心临床试验中收集68例NSRBP患者报告的疼痛强度、身体功能、健康相关生活质量、睡眠质量和情绪功能的结局指标。在12个月的随访中评估阿片类药物使用的变化、减少或消除。通过最小临床重要差异（MCIDs）来评估整体治疗反应，采用了包含不同健康领域的有效复合结果测量。客观设备指标提供有关系统利用率、环路性能（剂量准确性）和神经生理学剂量指标的信息。结果：在12个月时，79%的患者报告疼痛强度减轻≥50%，48%的患者获得≥80%的疼痛缓解。在3个月和12个月时，所有患者报告的评估结果均有显著改善。大约一半在基线时服用阿片类药物的患者自愿减少或消除了阿片类药物的使用。系统利用率为> - 80%，剂量比> - 1.3（即比ECAP阈值高30%），剂量精度高，使激发的ECAP在系统上设定的目标ECAP的3.5 μV范围内。结论：ecap控制的闭环SCS是NSRBP患者安全有效的治疗选择。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Spine 医学-临床神经学

CiteScore

5.90

自引率

6.70%

发文量

361

审稿时长

6.0 months

期刊介绍： Lippincott Williams & Wilkins is a leading international publisher of professional health information for physicians, nurses, specialized clinicians and students. For a complete listing of titles currently published by Lippincott Williams & Wilkins and detailed information about print, online, and other offerings, please visit the LWW Online Store. Recognized internationally as the leading journal in its field, Spine is an international, peer-reviewed, bi-weekly periodical that considers for publication original articles in the field of Spine. It is the leading subspecialty journal for the treatment of spinal disorders. Only original papers are considered for publication with the understanding that they are contributed solely to Spine. The Journal does not publish articles reporting material that has been reported at length elsewhere.