Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.
Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, UK.
Neuromodulation. 2021 Apr;24(3):471-478. doi: 10.1111/ner.13321. Epub 2020 Nov 29.
OBJECTIVES: The aim of this study was to compare the efficacy in reducing pain intensity in adult subjects suffering from chronic back and leg pain of burst (BST) and tonic sub-threshold stimulation at 500 Hz (T500) vs. sham stimulation delivered by a spinal cord stimulation (SCS) device capable of automated postural adjustment of current intensity. MATERIALS AND METHODS: A multicentre randomized double-blind, three-period, three-treatment, crossover study was undertaken at two centers in the United Kingdom. Patients who had achieved stable pain relief with a conventional SCS capable of automated postural adjustment of current intensity were randomized to sequences of BST, T500, and sham SCS with treatment order balanced across the six possible sequences. A current leakage was programmed into the implantable pulse generator (IPG) in the sham period. The primary outcome was patient reported pain intensity using a visual analog scale (VAS). RESULTS: Nineteen patients were enrolled and randomized. The mean reduction in pain with T500 was statistically significantly greater than that observed with either sham (25%; 95% CI, 8%-38%; p = 0.008) or BST (28%; 95% CI, 13%-41%; p = 0.002). There were no statistically significant differences in pain VAS for BST versus Sham (5%; 95% CI, -13% to 27%; p = 0.59). Exploratory sub-group analyses by study site and sex were also conducted for the T500 vs. sham and BST versus sham comparisons. CONCLUSIONS: The findings suggest a superior outcome versus sham from T500 stimulation over BST stimulation and a practical equivalence between BST and sham in a group of subjects with leg and back pain habituated to tonic SCS and having achieved a stable status with stimulation.
目的:本研究旨在比较爆发式(BST)和 500Hz 亚阈强直刺激(T500)与能够自动调整电流强度的脊髓刺激(SCS)设备的假刺激在减轻慢性腰背腿痛成人患者疼痛强度方面的疗效。
材料与方法:这是一项在英国的两个中心进行的多中心、随机、双盲、三周期、三处理、交叉研究。已经通过能够自动调整电流强度的常规 SCS 获得稳定疼痛缓解的患者,被随机分为 BST、T500 和假 SCS 治疗组,治疗顺序在六个可能的序列中平衡。在假刺激期间,对植入式脉冲发生器(IPG)编程一个电流泄漏。主要结局是患者使用视觉模拟量表(VAS)报告的疼痛强度。
结果:19 名患者入组并随机分组。与假刺激相比,T500 治疗的疼痛缓解程度显著更大(25%;95%CI,8%-38%;p=0.008),与 BST 治疗相比也更大(28%;95%CI,13%-41%;p=0.002)。BST 与假刺激之间的 VAS 疼痛评分无统计学显著差异(5%;95%CI,-13%至 27%;p=0.59)。还对 T500 与假刺激以及 BST 与假刺激的比较进行了基于研究地点和性别的探索性亚组分析。
结论:这些发现表明,与 BST 刺激相比,T500 刺激的结果优于假刺激,并且在一组已经习惯强直 SCS 且通过刺激达到稳定状态的腰背腿痛患者中,BST 与假刺激之间具有实际等效性。
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