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快速起效的亚感知治疗的自动化神经给药:一项多中心研究的脊髓刺激持续结果

Automated Neural Dosing for Fast-Acting Subperception Therapy: Sustained Spinal Cord Stimulation Outcomes from a Multicenter Study.

作者信息

Ferro Richard, North James, Kranenburg Andy, Pyles Stephen, Dorenkamp Clay, Poston Jason, Schneider John, Auten Kacey, Goldberg Edward

机构信息

Multidisciplinary Pain Management Services, 2211 Association Drive, Suite 100, Okemos, MI, 48864, USA.

Carolinas Pain Institute and Center for Clinical Research, Winston-Salem, NC, USA.

出版信息

Pain Ther. 2025 Jul 3. doi: 10.1007/s40122-025-00758-y.

DOI:10.1007/s40122-025-00758-y
PMID:40603812
Abstract

INTRODUCTION

Therapy habituation is a barrier to sustained success with spinal cord stimulation (SCS). Fast-acting subperception therapy (FAST) is a low-frequency, subperception waveform that can achieve rapid wash-in pain relief via the surround inhibition mechanism. FAST-Autodose is an automated neural dosing schedule designed to provide effective pain relief while potentially reducing habituation and maintaining therapy within an efficient therapeutic window-thus eliminating the need for manual patient adjustments. We assessed the efficacy of FAST-Autodose and provide preliminary long-term outcomes.

METHODS

We conducted a retrospective review of consecutive patients from a multicenter, observational study in the USA who had received SCS and used FAST-Autodose to manage their chronic pain of the low back and/or lower limbs. The numerical rating scale (NRS) evaluated the overall pain intensity until the last follow-up postimplantation.

RESULTS

Data were collected from 73 patients who had used FAST-Autodose for 11.9 ± 6.8 months on average. At the last follow-up visit (average 1.8 ± 1.5 years after implantation), the NRS score for overall pain decreased by 5.1 ± 2.8 points, to a mean of 2.1 ± 2.0 (p < 0.0001) and 69% of patients reported minimal pain (NRS ≤ 2/10). In total, 23 patients had been implanted for more than 3.5 years and had used FAST-Autodose for a mean of 17.7 ± 5.9 months; in these patients, the mean NRS pain score decreased by 6.1 ± 2.0 points to 1.6 ± 1.2 points (p < 0.0001).

CONCLUSIONS

FAST-Autodose is a novel, automated, subperception paradigm for SCS. In our study, this program delivered significant and sustained pain relief in patients with chronic low back and/or leg pain who had been implanted with SCS for up to 3.6 years. These preliminary results constitute a promising rationale for larger, prospective studies on the long-term efficacy of FAST-Autodose.

CLINICAL TRIAL REGISTRATION

Trial registered at clinicaltrials.gov (ID: NCT01550575).

摘要

引言

治疗适应是脊髓刺激(SCS)持续取得成功的一个障碍。快速起效的阈下感知疗法(FAST)是一种低频阈下感知波形,可通过周围抑制机制迅速实现疼痛缓解。FAST自动给药是一种自动神经给药方案,旨在提供有效的疼痛缓解,同时可能减少适应现象,并将治疗维持在有效的治疗窗口内,从而无需患者手动调整。我们评估了FAST自动给药的疗效并提供了初步的长期结果。

方法

我们对美国一项多中心观察性研究中连续接受SCS并使用FAST自动给药来管理其腰背部和/或下肢慢性疼痛的患者进行了回顾性分析。数字评分量表(NRS)评估了直至植入后最后一次随访时的总体疼痛强度。

结果

收集了73例平均使用FAST自动给药11.9±6.8个月的患者的数据。在最后一次随访时(植入后平均1.8±1.5年),总体疼痛的NRS评分下降了5.1±2.8分,平均降至2.1±2.0分(p<0.0001),69%的患者报告疼痛轻微(NRS≤2/10)。共有23例患者植入超过3.5年,平均使用FAST自动给药17.7±5.9个月;在这些患者中,平均NRS疼痛评分下降了6.1±2.0分至1.6±1.2分(p<0.0001)。

结论

FAST自动给药是一种用于SCS的新型、自动、阈下感知模式。在我们的研究中,该方案为植入SCS长达3.6年的慢性腰背部和/或腿部疼痛患者提供了显著且持续的疼痛缓解。这些初步结果为关于FAST自动给药长期疗效的更大规模前瞻性研究提供了有前景的理论依据。

临床试验注册

该试验在clinicaltrials.gov注册(标识符:NCT01550575)。

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本文引用的文献

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Biomedicines. 2025 Apr 30;13(5):1091. doi: 10.3390/biomedicines13051091.
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Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States.采用快速起效的亚感知疗法进行脊髓刺激的两年疗效:美国一项真实世界多中心研究的结果
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Neuromodulation in chronic pain management: addressing persistent doubts in spinal cord stimulation.
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Two-Year Outcomes Using Fast-Acting, Sub-Perception Therapy for Spinal Cord Stimulation: A European, Real-World, Multicenter Experience.使用快速起效、亚感知疗法进行脊髓刺激的两年结果:一项欧洲真实世界多中心经验
J Clin Med. 2024 Nov 20;13(22):6999. doi: 10.3390/jcm13226999.
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