Department of Neurological Surgery, Duke University Medical Center, Durham, North Carolina, USA.
Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Chestnut Hill, Massachusetts, USA.
Neurosurgery. 2023 Apr 1;92(4):716-724. doi: 10.1227/neu.0000000000002305. Epub 2023 Feb 14.
High-impact chronic low back pain (CLBP) correlates with high healthcare resource utilization. Therapies that can alter impact status may provide beneficial long-term economic benefits. An implantable restorative neurostimulation system (ReActiv8, Mainstay Medical) designed to over-ride multifidus inhibition to facilitate motor control restoration, thereby resolving mechanical low back pain symptoms, has shown significant durable clinical effects in moderately and severely impacted patients.
To examine changes in high-impact chronic low back pain in patients treated with restorative neurostimulation at 2 years.
ReActiv8-B is a prospective, international, multicenter trial to evaluate the safety and efficacy of restorative neurostimulation in patients with intractable CLBP and no prior surgery. For this longitudinal subanalysis, patients were stratified into low-, moderate-, and high-impact CLBP categories using the US Department of Health and Human Services definition comprising pain intensity, duration, and impact on work, self-care, and daily activities.
Of 2-year completers (n = 146), 71% had high-impact CLBP at baseline and this proportion reduced to 10%, with 85% reporting no or low impact. This corresponds with measurements of HRQoL returning to near-population norms.
In addition to clinically meaningful improvements in pain and function with long-term durability, the overwhelming majority of patients transitioned from a high- to a no- or low-impact CLBP state. This is typically associated with significantly lower healthcare-utilization levels. The of recovery trajectory is consistent with a restorative mechanism of action and suggests that over the long term, the improvement in these health states will be maintained.
高影响力慢性下背痛（CLBP）与高医疗资源利用率相关。能够改变影响状态的疗法可能会带来有益的长期经济效益。一种旨在克服多裂肌抑制以促进运动控制恢复的可植入修复性神经刺激系统（ReActiv8，Mainstay Medical），从而解决机械性下背痛症状，已在中度和重度受影响的患者中显示出显著的持久临床效果。
在接受神经刺激修复治疗的患者中，检查 2 年后高影响力慢性下背痛的变化。
ReActiv8-B 是一项前瞻性、国际、多中心试验，旨在评估修复性神经刺激在难治性 CLBP 且无既往手术史的患者中的安全性和疗效。对于这项纵向亚分析，患者根据美国卫生与公众服务部的定义，使用疼痛强度、持续时间以及对工作、自我护理和日常活动的影响，分为低、中、高影响力 CLBP 类别。
在 2 年完成者中（n=146），71%的患者基线时患有高影响力 CLBP，这一比例降低至 10%，85%的患者报告无或低影响。这与 HRQoL 的测量结果相吻合，接近人群正常值。
除了疼痛和功能的临床意义上的改善以及长期耐久性之外，绝大多数患者从高影响力 CLBP 状态转变为无或低影响力 CLBP 状态。这通常与显著降低的医疗利用率水平相关。恢复轨迹与修复作用机制一致，表明在长期内，这些健康状况的改善将得到维持。
