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.
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.