Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction
Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction
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DOI：
10.1016/j.neurom.2022.08.457
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发表时间：
2023-01-04
期刊：
影响因子：
2.8
通讯作者：
Eldabe, Sam
中科院分区：
文献类型：
--
作者：
Gilligan, Christopher;Volschenk, Willem;Eldabe, Sam
背景资料：恢复性神经刺激是一种针对难治性慢性腰痛（CLBP）患者的康复治疗，该患者与导致神经肌肉控制受损的腰多裂肌功能障碍相关。ReActiv 8-B随机、假手术对照试验提供了植入式恢复性神经刺激器的有效性和安全性的证据。此前发表在这本杂志上的两年的分析表明，应计的临床效益和长期的durability.Objective：三年的有效性和安全性评价难治性，致残CLBP继发于多裂肌功能障碍和无脊柱手术的适应症。材料和方法：前瞻性，观察随访的204植入试验参与者。在基线、激活后6个月、1年、2年和3年评估腰痛视觉模拟量表（VAS）、奥斯韦斯特里残疾指数（ODI）、EuroQol生活质量调查和阿片类药物摄入。采用混合效应模型重复测量方法对连续结局的缺失数据进行隐式插补，并对比例估计值进行多重插补。结果：数据收集自133名参与者，16名患者因冠状病毒疾病限制而错过了3年随访，但仍可用于未来随访。共有62%的参与者的VAS降低了70%，67%的参与者报告CLBP消退（VAS
Background: Restorative neurostimulation is a rehabilitative treatment for patients with refractory chronic low back pain (CLBP) associated with dysfunction of the lumbar multifidus muscle resulting in impaired neuromuscular control. The ReActiv8-B ran-domized, sham-controlled trial provided evidence of the effectiveness and safety of an implanted, restorative neurostimulator. The two-year analysis previously published in this journal demonstrated accrual of clinical benefits and long-term durability.Objective: Evaluation of three-year effectiveness and safety in patients with refractory, disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery.Materials and Methods: Prospective, observational follow-up of the 204 implanted trial participants. Low back pain visual analog scale (VAS), Oswestry Disability Index (ODI), EuroQol quality of life survey, and opioid intake were assessed at baseline, six months, and one, two, and three years after activation. The mixed-effects model repeated measures approach was used to provide implicit imputations of missing data for continuous outcomes and multiple imputation for proportion estimates.Results: Data were collected from 133 participants, and 16 patients missed their three-year follow-up because of coronavirus disease restrictions but remain available for future follow-up. A total of 62% of participants had a z 70% VAS reduction, and 67% reported CLBP resolution (VAS