Abstract：
Neuromuscular instability of the lumbar spine resulting from impaired motor control and degeneration of the multifidus muscle is a known root cause of refractory chronic low back pain (LBP). An implantable neurostimulation system that aims to restore multifidus motor control by stimulating the L2 medial branch of the dorsal ramus thereby relieving pain and reducing disability has demonstrated clinically significant benefits in the clinical trial setting. The 1-year results of a single-site real-world cohort study are presented.
This study recruited 44 consecutive patients with refractory, predominantly nociceptive axial chronic LBP, evidence of multifidus dysfunction, and no surgical indications or history of surgical intervention for chronic LBP. Each patient was implanted with a neurostimulation device. Pain (numeric rating scale), disability (Oswestry Disability Index), and quality of life (5-level EuroQol 5-Dimension) outcomes were collected at baseline and 3, 6, and 12 months after activation.
Statistically significant improvements in pain, disability, and quality of life from baseline were seen at all assessment time points. At 12 months after activation, mean ± standard error of the mean numeric rating scale score was reduced from 7.6 ± 0.2 to 3.9 ± 0.4 (P < 0.001), Oswestry Disability Index score was reduced from 43.0 ± 2.8 to 25.8 ± 3.9 (P < 0.001), and 5-level EuroQol 5-Dimension index improved from 0.504 ± 0.034 to 0.755 ± 0.039 (P < 0.001). No lead migrations were observed. One patient required revision due to lead fracture.
Restorative neurostimulation is a new treatment option for well-selected patients with refractory chronic LBP. Clinically meaningful improvements in pain, disability, and quality of life demonstrated in routine clinical practice are consistent with published results of controlled trials.
This study recruited 44 consecutive patients with refractory, predominantly nociceptive axial chronic LBP, evidence of multifidus dysfunction, and no surgical indications or history of surgical intervention for chronic LBP. Each patient was implanted with a neurostimulation device. Pain (numeric rating scale), disability (Oswestry Disability Index), and quality of life (5-level EuroQol 5-Dimension) outcomes were collected at baseline and 3, 6, and 12 months after activation.
Statistically significant improvements in pain, disability, and quality of life from baseline were seen at all assessment time points. At 12 months after activation, mean ± standard error of the mean numeric rating scale score was reduced from 7.6 ± 0.2 to 3.9 ± 0.4 (P < 0.001), Oswestry Disability Index score was reduced from 43.0 ± 2.8 to 25.8 ± 3.9 (P < 0.001), and 5-level EuroQol 5-Dimension index improved from 0.504 ± 0.034 to 0.755 ± 0.039 (P < 0.001). No lead migrations were observed. One patient required revision due to lead fracture.
Restorative neurostimulation is a new treatment option for well-selected patients with refractory chronic LBP. Clinically meaningful improvements in pain, disability, and quality of life demonstrated in routine clinical practice are consistent with published results of controlled trials.
摘要：
背景：由运动控制受损和多裂肌变性引起的腰椎神经肌肉不稳定是难治性慢性下腰痛（LBP）的已知根本原因。旨在通过刺激背支的L2内侧支来恢复多裂运动控制从而减轻疼痛和减少残疾的可植入神经刺激系统在临床试验环境中已显示出临床上显著的益处。介绍了单站点真实世界队列研究的1年结果。
方法：本研究连续招募了44例难治性，主要是伤害性轴向慢性LBP，多裂功能障碍的证据，无手术指征或慢性LBP手术干预史。每位患者都植入了神经刺激装置。疼痛（数字评定量表），残疾（Oswestry残疾指数），在基线和激活后3,6和12个月收集生活质量(5级EuroQol5维)结局.
结果：疼痛的显著改善，残疾,在所有评估时间点均观察基线时的生活质量.在激活后12个月,平均数字评分的平均值±标准误差从7.6±0.2降低到3.9±0.4（P<0.001），Oswestry残疾指数评分从43.0±2.8降至25.8±3.9(P<0.001),5级EuroQol5维指数从0.504±0.034提高到0.755±0.039(P<0.001)。没有观察到铅迁移。一名患者因导线断裂需要翻修。
结论：对于经过精心挑选的难治性慢性LBP患者，恢复性神经刺激是一种新的治疗选择。临床上有意义的疼痛改善，残疾,在常规临床实践中证明的生活质量与已发表的对照试验结果一致.
方法：本研究连续招募了44例难治性，主要是伤害性轴向慢性LBP，多裂功能障碍的证据，无手术指征或慢性LBP手术干预史。每位患者都植入了神经刺激装置。疼痛（数字评定量表），残疾（Oswestry残疾指数），在基线和激活后3,6和12个月收集生活质量(5级EuroQol5维)结局.
结果：疼痛的显著改善，残疾,在所有评估时间点均观察基线时的生活质量.在激活后12个月,平均数字评分的平均值±标准误差从7.6±0.2降低到3.9±0.4（P<0.001），Oswestry残疾指数评分从43.0±2.8降至25.8±3.9(P<0.001),5级EuroQol5维指数从0.504±0.034提高到0.755±0.039(P<0.001)。没有观察到铅迁移。一名患者因导线断裂需要翻修。
结论：对于经过精心挑选的难治性慢性LBP患者，恢复性神经刺激是一种新的治疗选择。临床上有意义的疼痛改善，残疾,在常规临床实践中证明的生活质量与已发表的对照试验结果一致.
