一种新型、无感觉异常的脊髓刺激波形治疗慢性神经性腰痛：前瞻性、单臂、剂量反应研究的 6 个月结果。

A Novel, Paresthesia-Free Spinal Cord Stimulation Waveform for Chronic Neuropathic Low Back Pain: Six-Month Results of a Prospective, Single-Arm, Dose-Response Study.

机构信息

Hunter Pain Specialists, Broadmeadow, New South Wales, Australia; Genesis Research Services, Broadmeadow, New South Wales, Australia; University of Newcastle, School of Biomedical Sciences and Pharmacy, College of Health, Medicine and Wellbeing, Callaghan, New South Wales, Australia.

Hunter Pain Specialists, Broadmeadow, New South Wales, Australia; Genesis Research Services, Broadmeadow, New South Wales, Australia.

出版信息

Neuromodulation. 2023 Oct;26(7):1412-1423. doi: 10.1016/j.neurom.2023.06.007. Epub 2023 Jul 22.

DOI:10.1016/j.neurom.2023.06.007

PMID:37486284

Abstract

OBJECTIVES

The aim of this prospective, single-blinded, dose-response study was to evaluate the safety and efficacy of a novel, paresthesia-free (subperception) spinal cord stimulation (SCS) waveform designed to target dorsal horn dendrites for the treatment of chronic neuropathic low back pain (LBP).

MATERIALS AND METHODS

Twenty-seven participants with chronic neuropathic LBP were implanted with a commercial SCS system after a successful trial of SCS therapy. Devices were programmed to deliver the investigative waveform (100 Hz, 1000 μs, T9/T10 bipole) at descending stimulation perception threshold amplitudes (80%, 60%, 40%). Programs were evaluated at six, ten, and 14 weeks, after which participants selected their preferred program, with more follow-up at 26 weeks (primary outcomes). Participants were blinded to the nature of the programming. Pain score (visual analog scale [VAS]), Brief Pain Inventory (BPI), quality of life (EQ-5D-5L), and health status (36-Item Short Form [SF-36]) were measured at baseline and follow-ups. Responder rate, treatment satisfaction, clinician global impression of change, and adverse events (AEs) also were evaluated.

RESULTS

Mean (± SD) baseline VAS was 72.5 ± 11.2 mm. At 26 weeks (n = 26), mean change from baseline in VAS was -51.7 mm (95% CI, -60.7 to -42.7; p < 0.001), with 76.9% of participants reporting ≥50% VAS reduction, and 46.2% reporting ≥80% VAS reduction. BPI, EQ-5D-5L, and SF-36 scores were all statistically significantly improved at 26 weeks (p < 0.001), and 100% of participants were satisfied with their treatment. There were no unanticipated AEs related to the study intervention, device, or procedures.

CONCLUSIONS

This novel, paresthesia-free stimulation waveform may be a safe and effective option for patients with chronic neuropathic LBP eligible for SCS therapy and is deliverable by all current commercial SCS systems.

CLINICAL TRIAL REGISTRATION

This study is registered on anzctr.org.au with identifier ACTRN12618000647235.

摘要

目的

本前瞻性、单盲、剂量反应研究旨在评估一种新型、无痛觉（亚感知）脊髓刺激（SCS）波形的安全性和有效性，该波形旨在针对背角树突(target dorsal horn dendrites)，用于治疗慢性神经性腰痛（LBP）。

材料和方法

27 名患有慢性神经性 LBP 的参与者在成功进行 SCS 治疗试验后，植入了商业 SCS 系统。设备被编程为以下降刺激感知阈值幅度（80%、60%、40%）输送研究性波形（100Hz，1000μs，T9/T10 双极）。在 6、10 和 14 周后评估方案，参与者选择他们喜欢的方案，之后在 26 周（主要结果）进行更多的随访。参与者对编程的性质不知情。在基线和随访时测量疼痛评分（视觉模拟量表[VAS]）、简明疼痛量表（BPI）、生活质量（EQ-5D-5L）和健康状况（36 项简短健康调查问卷[SF-36]）。还评估了应答率、治疗满意度、临床医生对变化的总体印象和不良事件（AE）。

结果

平均（±标准差）基线 VAS 为 72.5±11.2mm。在 26 周（n=26）时，与基线相比，VAS 的平均变化为-51.7mm（95%CI，-60.7 至-42.7；p<0.001），76.9%的参与者报告 VAS 降低≥50%，46.2%的参与者报告 VAS 降低≥80%。26 周时，BPI、EQ-5D-5L 和 SF-36 评分均有统计学显著改善（p<0.001），100%的参与者对治疗满意。与研究干预、设备或程序无关的意外 AE 均未发生。