Frank Schwab, Nagy Mekhail, Kiran V Patel, Meredith Langhorst, Robert D Heros, Jonathan Gentile, Sherif Costandi, Gregory Moore, Christopher Gilmore, Smith Manion, Krishnan Chakravarthy, S Craig Meyer, Justin V Bundy, Jordan L Tate, Rebecca Sanders, Sandeep Vaid, Oszkar Szentirmai, Johnathan Goree, Vikas V Patel, Jeff Lehmen, Mehul J Desai, Jason E Pope, Anthony Giuffrida, Salim Hayek, Sohrab Singh Virk, Richard Paicius, William R Klemme, Robert Levy, Christopher Gilligan
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In this randomized controlled trial, we report outcomes from a cohort of patients with CLBP associated with multifidus dysfunction treated with restorative neurostimulation compared to those randomized to a control group receiving optimal medical management (OMM) over 1 year.</p><p><strong>Methods: </strong>RESTORE is a multicenter, open-label randomized controlled trial. Candidates were assessed for CLBP associated with multifidus dysfunction, with no indication for or history of lumbar spine surgery. Participants were randomized to either restorative neurostimulation with the ReActiv8 system or OMM. The primary endpoint was a comparison of the mean change in the Oswestry Disability Index (ODI) between the treatment and control arms at 1 year, and secondary endpoints included pain (numeric rating scale [NRS]) and health-related quality of life (EuroQol Five-Dimension [EQ-5D-5L]).</p><p><strong>Results: </strong>A total of 203 patients, average age 47 years, and with an average 11-year history of low back pain, were included in the analysis. The primary endpoint was a statistically significant demonstration of a clinically relevant mean improvement in the Oswestry Disability Index (ODI) between restorative neurostimulation and OMM arms: ODI (-19.7 ± 1.4 vs. -2.9 ± 1.4; p < 0.001). Additionally, improvements in both the numeric rating scale (NRS) (-3.6 ± 0.2 vs. -0.6 ± 0.2; p < 0.001) and EuroQol Five-Dimension (EQ-5D-5L) (0.155 ± 0.012 vs. 0.008 ± 0.012; p < 0.001) were statistically and clinically significant in the restorative neurostimulation arm compared to the OMM arm.</p><p><strong>Conclusion: </strong>The RESTORE trial demonstrates that restorative neurostimulation is a safe, reversible, clinically effective, and highly durable option for patients suffering with nonoperative CLBP associated with multifidus dysfunction. 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引用次数: 0
摘要
许多介入策略通常用于治疗慢性腰痛（CLBP），尽管很少有专门针对引起腰痛的独特潜在病理机制的介入策略。恢复性神经刺激被认为是治疗多裂肌功能障碍引起的机械性CLBP的一种特殊方法。在这项随机对照试验中，我们报告了一组接受恢复性神经刺激治疗的CLBP合并多裂肌功能障碍患者的结果，并将这些患者随机分配到接受最佳医疗管理（OMM）治疗1年的对照组。方法：RESTORE是一项多中心、开放标签的随机对照试验。评估候选人是否存在与多裂肌功能障碍相关的CLBP，没有腰椎手术指征或病史。参与者被随机分配到ReActiv8系统或OMM的恢复性神经刺激组。主要终点是治疗组和对照组1年时Oswestry残疾指数（ODI）的平均变化比较，次要终点包括疼痛（数值评定量表[NRS]）和健康相关生活质量（EuroQol Five-Dimension [EQ-5D-5L]）。结果：共有203例患者被纳入分析，平均年龄47岁，平均有11年的腰痛病史。主要终点是恢复性神经刺激和OMM手臂之间的Oswestry残疾指数（ODI）的临床相关平均改善的统计显著性证明：ODI(-19.7±1.4 vs -2.9±1.4；结论：RESTORE试验表明，对于伴有多裂肌功能障碍的非手术性CLBP患者，恢复性神经刺激是一种安全、可逆、临床有效且高度持久的选择。这表明治疗优于OMM 1年，是解决主要健康负担和未满足临床需求的重要里程碑。试验注册：ClinicalTrials.gov标识符：NCT04803214。
Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus Dysfunction.
Introduction: Many interventional strategies are commonly used to treat chronic low back pain (CLBP), though few are specifically intended to target the distinct underlying pathomechanisms causing low back pain. Restorative neurostimulation has been suggested as a specific treatment for mechanical CLBP resulting from multifidus dysfunction. In this randomized controlled trial, we report outcomes from a cohort of patients with CLBP associated with multifidus dysfunction treated with restorative neurostimulation compared to those randomized to a control group receiving optimal medical management (OMM) over 1 year.
Methods: RESTORE is a multicenter, open-label randomized controlled trial. Candidates were assessed for CLBP associated with multifidus dysfunction, with no indication for or history of lumbar spine surgery. Participants were randomized to either restorative neurostimulation with the ReActiv8 system or OMM. The primary endpoint was a comparison of the mean change in the Oswestry Disability Index (ODI) between the treatment and control arms at 1 year, and secondary endpoints included pain (numeric rating scale [NRS]) and health-related quality of life (EuroQol Five-Dimension [EQ-5D-5L]).
Results: A total of 203 patients, average age 47 years, and with an average 11-year history of low back pain, were included in the analysis. The primary endpoint was a statistically significant demonstration of a clinically relevant mean improvement in the Oswestry Disability Index (ODI) between restorative neurostimulation and OMM arms: ODI (-19.7 ± 1.4 vs. -2.9 ± 1.4; p < 0.001). Additionally, improvements in both the numeric rating scale (NRS) (-3.6 ± 0.2 vs. -0.6 ± 0.2; p < 0.001) and EuroQol Five-Dimension (EQ-5D-5L) (0.155 ± 0.012 vs. 0.008 ± 0.012; p < 0.001) were statistically and clinically significant in the restorative neurostimulation arm compared to the OMM arm.
Conclusion: The RESTORE trial demonstrates that restorative neurostimulation is a safe, reversible, clinically effective, and highly durable option for patients suffering with nonoperative CLBP associated with multifidus dysfunction. This demonstration of treatment superiority over OMM through 1 year is a significant milestone in addressing a major health burden and unmet clinical need.
期刊介绍：
Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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