Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform
Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform
复制标题
DOI：
10.1111/ner.12698
复制
发表时间：
2018-01-01
期刊：
影响因子：
2.8
通讯作者：
Wilson, Derron
中科院分区：
文献类型：
--
作者：
Deer, Timothy;Slavin, Konstantin V.;Wilson, Derron
目的：多中心、随机、非盲、交叉研究的目的是使用神经调节和BURST取得成功（朝阳）研究的目的是确定向躯干和/或四肢慢性疼痛患者提供传统强直刺激和爆发刺激的设备的安全性和有效性。在成功的强直试验后，100名受试者被随机分配在前12周接受一种刺激模式，然后在接下来的12周接受另一种刺激模式。主要终点评估了强直性和爆发性之间平均每日总体VAS评分的受试者内差异的非劣效性。使用12周和24周访视时的数据进行意向治疗分析。然后，受试者使用他们选择的刺激模式，并随访一年。使用描述性统计分析其他终点并表征设备的安全性。结果：朝阳研究证明爆发刺激不劣于强直刺激（p
Objective: The purpose of the multicenter, randomized, unblinded, crossover Success Using Neuromodulation with BURST (SUNBURST) study was to determine the safety and efficacy of a device delivering both traditional tonic stimulation and burst stimulation to patients with chronic pain of the trunk and/or limbs.Methods: Following a successful tonic trial, 100 subjects were randomized to receive one stimulation mode for the first 12 weeks, and then the other stimulation mode for the next 12 weeks. The primary endpoint assessed the noninferiority of the within-subject difference between tonic and burst for the mean daily overall VAS score. An intention-to-treat analysis was conducted using data at the 12- and 24-week visits. Subjects then used the stimulation mode of their choice and were followed for one year. Descriptive statistics were used analyze additional endpoints and to characterize the safety profile of the device.Results: The SUNBURST study demonstrated that burst stimulation is noninferior to tonic stimulation (p