Slavin Konstantin V, North Richard B, Deer Timothy R, Staats Peter, Davis Kristina, Diaz Roni
Department of Neurosurgery, University of Illinois College of Medicine, 912 South Wood St, Chicago, IL, USA.
Departments of Neurosurgery, Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Trials. 2016 Dec 1;17(1):569. doi: 10.1186/s13063-016-1706-5.
Burst stimulation is a novel form of neurostimulation for the treatment of chronic pain which has demonstrated promise in small uncontrolled studies, but has not yet gained approval for use in the U.S. We report the study methods for an ongoing multicenter, randomized, controlled, cross-over study designed to gain United States Food and Drug Administration (FDA) approval for burst stimulation.
Participants who are candidates for a currently approved neurostimulation device were enrolled and screened. Participants who fail a tonic trial evaluation, have significant depressive symptoms, or evidence lack of compliance with study procedures by failing to complete 7 days of a Pain Diary are excluded. Participants receiving a permanent implant are randomized to receive: (1) 12 weeks of tonic followed by 12 weeks of burst stimulation or (2) 12 weeks of burst stimulation followed by 12 weeks of tonic stimulation. Assessments occur at 6, 12, 18, and 24 weeks. After 24 weeks, participants choose their preferred therapy and are assessed every 6 months for up to 2 years. All patients had the device leads inserted at the site of a successful tonic stimulation trial. Assessments include: a Pain Diary using a Visual Analog Scale (VAS) for overall, trunk, and limb pain, the Beck Depression Inventory, the Pain Catastrophizing Scale, the Oswestry Disability Index, paresthesia, satisfaction, and therapy preference. Reported adverse events are collected throughout the study. The primary endpoint is the noninferiority of burst stimulation compared to tonic measured by the within-subject difference in the mean overall VAS score at the end of each 12-week stimulation period.
This trial represents the largest controlled trial of burst stimulation to date, and is expected to yield important information regarding the safety and efficacy of burst stimulation.
ClinicalTrials.gov, NCT02011893 . Registered on 10 December 2013.
爆发式刺激是一种用于治疗慢性疼痛的新型神经刺激形式，在小型非对照研究中已显示出前景，但尚未获得美国的使用批准。我们报告了一项正在进行的多中心、随机、对照、交叉研究的研究方法，该研究旨在获得美国食品药品监督管理局（FDA）对爆发式刺激的批准。
招募并筛选符合当前批准的神经刺激设备使用条件的参与者。未能通过强直试验评估、有明显抑郁症状或因未完成7天疼痛日记而证明不符合研究程序的参与者被排除。接受永久性植入的参与者被随机分配接受：（1）12周的强直刺激，随后是12周的爆发式刺激；或（2）12周的爆发式刺激，随后是12周的强直刺激。在第6、12、18和24周进行评估。24周后，参与者选择他们喜欢的治疗方法，并在长达2年的时间里每6个月进行一次评估。所有患者的设备导线均在强直刺激试验成功的部位插入。评估包括：使用视觉模拟量表（VAS）记录总体、躯干和肢体疼痛的疼痛日记、贝克抑郁量表、疼痛灾难化量表、奥斯威斯残疾指数、感觉异常、满意度和治疗偏好。在整个研究过程中收集报告的不良事件。主要终点是在每个12周刺激期结束时，通过受试者内平均总体VAS评分差异测量的爆发式刺激与强直刺激相比的非劣效性。
该试验是迄今为止最大规模的爆发式刺激对照试验，预计将产生有关爆发式刺激安全性和有效性的重要信息。
ClinicalTrials.gov，NCT02011893。于2013年12月10日注册。
