Gilligan Christopher, Burnside Diane, Grant Lisa, Yong R Jason, Mullins Peter M, Schwab Frank, Mekhail Nagy
Division of Pain Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA, USA.
Mainstay Medical, Minneapolis, MN, USA.
Pain Ther. 2023 Apr;12(2):607-620. doi: 10.1007/s40122-023-00475-4. Epub 2023 Feb 14.
Chronic low back pain (CLBP) is the leading cause of years lived with disability globally. The role of restorative neurostimulation in the treatment of patients with refractory mechanical CLBP and multifidus muscle dysfunction has been established in one randomized controlled trial (RCT) and several clinical studies that demonstrated both safety and clinical benefit. This post-market trial provides a direct comparison to optimized medical management to test the hypothesis that the addition of restorative neurostimulation to current care paradigms results in significant improvements in back pain-related disability.
This trial will include people who have reported significant levels of back pain and back pain-related disability with symptoms that have persisted for longer than 6 months prior to enrollment and resulted in pain on most days in the 12 months prior to enrollment. Eligible patients will be randomized to either optimal medical management or optimal medical management plus ReActiv8® restorative neurostimulation therapy. Patient-reported outcomes will be collected at regular intervals out to the 1-year primary endpoint, at which time the patients in the control arm will be offered implantation with the ReActiv8 system. Assessment of each group will continue for an additional year.
The RESTORE trial follows the principles of the Declaration of Helsinki. The WCG IRB acts as the Central Institutional Review Board (IRB) for most sites and some sites will receive local IRB approval prior to enrollment of patients. Each IRB assessed the protocol and related documentation. The protocol complies with Good Clinical Practice (GCP). All patients provide written informed consent to participate in the trial.
Version C, 07 Sep 2022.
gov registration number. NCT04803214 registered March 17, 2021.
慢性下腰痛（CLBP）是全球致残年限的主要原因。一项随机对照试验（RCT）和多项临床研究证实了恢复性神经刺激在治疗难治性机械性CLBP和多裂肌功能障碍患者中的作用，这些研究均证明了其安全性和临床益处。这项上市后试验将与优化的药物治疗进行直接比较，以检验在当前护理模式中添加恢复性神经刺激可显著改善背痛相关残疾这一假设。
本试验将纳入那些报告有严重背痛及背痛相关残疾症状的人群，这些症状在入组前已持续超过6个月，且在入组前12个月的大多数日子里都导致疼痛。符合条件的患者将被随机分为接受最佳药物治疗或最佳药物治疗加ReActiv8®恢复性神经刺激疗法两组。将定期收集患者报告的结局，直至1年的主要终点，届时将为对照组患者提供ReActiv8系统植入。对每组的评估将再持续一年。
RESTORE试验遵循《赫尔辛基宣言》的原则。WCG IRB作为大多数研究点的中央机构审查委员会（IRB），部分研究点在患者入组前将获得当地IRB的批准。每个IRB都对方案及相关文件进行了评估。该方案符合良好临床实践（GCP）。所有患者均提供书面知情同意书以参与试验。
C版，2022年9月7日。
gov注册号。NCT04803214，于2021年3月17日注册。
