Ardeshiri Ardeshir, Amann Marco, Thomson Simon, Gilligan Christopher J
Department for Trauma Surgery and Orthopaedics, Klinikum Itzehoe, Itzahoe, Germany.
Orthopädisches Krankenhaus Schloss Werneck, Werneck, Germany.
Reg Anesth Pain Med. 2025 Mar 5;50(3):231-236. doi: 10.1136/rapm-2023-105032.
INTRODUCTION: Data on the Medicare-aged population show that older patients are major consumers of low back pain (LBP) interventions. An effective approach for patients with mechanical LBP that has been refractory to conservative management is restorative neurostimulation. The efficacy of restorative neurostimulation has been demonstrated in multiple prospective studies, with published follow-up over 4 years, showing a consistent durable effect. METHODS: To further examine the effect of restorative neurostimulation in an older demographic, data from three clinical studies were aggregated: ReActiv8-B prospectively followed 204 patients, ReActiv8-C study prospectively followed 87 patients and ReActiv8-PMCF prospectively followed 42 patients.Two hundred and sixty-one patients were identified with complete 2-year follow-up and divided into cohorts of equal size based of age quartiles.At 2 years from device activation, patients in either cohort were classified by change in disability (Oswestry Disability Index (ODI)) or change in pain score(NRS/VAS) and assessed as proportion of patients per group at each time point. Additionally, health-related quality of life (HRQoL) (EQ5D-5L) was longitudinally compared with baseline. Differences in proportions were assessed using χ and continuous variables by repeated measures analysis of variance. RESULTS: The oldest quartile (n=65) had a median age of 60 (56-82) years compared with the entire population (n=261) who had a median age of 49 (22-82) years. The completer analysis on patients with 2 years of continuous data showed improvement of a 50% in pain was achieved by 62% and 65% and a 15-point ODI improvement in 48% and 60% in the oldest quartile and entire population, respectively. HRQoL (EuroQol 5-Dimension) improved from baselines of 0.568 and 0.544 to 0.763 and 0.769 in the oldest quartile and entire population respectively. All age quartiles improved statistically and clinically over baseline. CONCLUSIONS: This aggregate analysis of three independent studies provides insight into the performance of restorative neurostimulation in an older population. Patients derived significant and clinically meaningful benefit in disability, pain and HRQoL. When compared with a similarly indicated cohort of younger patients, there were no statistically or clinically significant differences.
引言：医疗保险覆盖年龄人群的数据显示，老年患者是下腰痛（LBP）干预措施的主要消费者。对于保守治疗无效的机械性下腰痛患者，一种有效的治疗方法是恢复性神经刺激。多项前瞻性研究已证实恢复性神经刺激的疗效，已发表的4年以上随访结果显示其效果持续稳定。 方法：为进一步研究恢复性神经刺激在老年人群中的效果，汇总了三项临床研究的数据：ReActiv8 - B前瞻性随访了204例患者，ReActiv8 - C研究前瞻性随访了87例患者，ReActiv8 - PMCF前瞻性随访了42例患者。确定了261例有完整2年随访数据的患者，并根据年龄四分位数分为大小相等的队列。在设备激活2年后，根据残疾程度变化（奥斯威斯残疾指数（ODI））或疼痛评分变化（数字评分量表/视觉模拟评分法（NRS/VAS））对任一队列中的患者进行分类，并评估每个时间点每组患者的比例。此外，纵向比较健康相关生活质量（HRQoL）（EQ5D - 5L）与基线水平。使用卡方检验评估比例差异，使用重复测量方差分析评估连续变量。 结果：最年长的四分位数组（n = 65）的中位年龄为60（56 - 82）岁，而整个人群（n = 261）的中位年龄为49（22 - 82）岁。对有2年连续数据的患者进行的完整分析显示，最年长的四分位数组和整个人群中，分别有62%和65%的患者疼痛改善了50%，48%和60%的患者ODI改善了15分。HRQoL（欧洲五维健康量表）在最年长的四分位数组和整个人群中分别从基线水平的0.568和0.544提高到0.763和0.769。所有年龄四分位数组在统计学和临床上均较基线有所改善。 结论：对三项独立研究的汇总分析深入了解了恢复性神经刺激在老年人群中的表现。患者在残疾、疼痛和HRQoL方面获得了显著且具有临床意义的益处。与年龄相仿的年轻患者队列相比，在统计学或临床上均无显著差异。
Pain Med. 2023-12-1
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