Muhammad Sajjad, Roeske Sandra, Chaudhry Shafqat Rasul, Kinfe Thomas Mehari
Department of Neurosurgery, Rheinische Friedrich Wilhelms University Hospital, Bonn, Germany.
DZNE, German Center for Neurodegenerative Diseases, Bonn, Rheinische Friedrich Wilhelms University Hospital, Bonn, Germany.
Neuromodulation. 2017 Oct;20(7):661-667. doi: 10.1111/ner.12611. Epub 2017 May 24.
Burst and 10 kHz spinal cord stimulation (SCS) demonstrated improvement for failed back surgery syndrome (FBSS) with predominant, refractory back pain. Here, we report the long-term follow-up of a previously published study comparing the safety and efficacy of burst vs. 10 kHz SCS for predominant back pain (70% of global pain) of FBSS patients.
This comparative, observational study extended the follow-up period up to 20 months evaluating both SCS modalities. Pain intensity (visual analog scale [VAS , VAS ]), functional capacity (Pittsburgh Sleep Quality Index [PSQI]; depression (Beck Depression Inventory [BDI]), stimulation parameters and hardware and/or stimulation associated adverse events were recorded and analyzed over time.
Overall VAS (t = 66.76, p < 0.001) and VAS (t = 4.763, p < 0.049; p < 0.001) declined over time. Burst significantly decreased VAS by 87.5% (±17.7) (mean 8 ± 0.76 to 1 ± 1.41; t =12.3, p < 0.001), and 10 kHz significant decreased VAS by 54.9% (±44) (mean 8 ± 0.63 to 3.5 ± 3.27; t =3.09, p = 0.027). No significant differences for between SCS types were revealed (t =1.75, p = 0.13). VAS was significantly suppressed for burst (burst: 3.6 ± 1.59 to 1.5 ± 1.06; t = 3.32, p = 0.013). A significant effect of time was found for functional outcome with no significant differences between SCS types (PSQI: t = 8.8, p = 0.012; and BDI: t = 53.3, p < 0.001). No stimulation/hardware-related complications occurred.
Long-term data of this comparative study suggests that burst responsiveness was superior to 10 kHz in our small-scale cohort, thus a larger, randomized-controlled comparative study design is highly recommended.
爆发式和10千赫兹脊髓刺激（SCS）已证明可改善以顽固性背痛为主的失败脊柱手术综合征（FBSS）。在此，我们报告一项先前发表研究的长期随访结果，该研究比较了爆发式与10千赫兹SCS对FBSS患者以背痛为主（占总体疼痛的70%）的安全性和有效性。
这项比较性观察研究将随访期延长至20个月，对两种SCS模式进行评估。随着时间的推移，记录并分析疼痛强度（视觉模拟量表[VAS ，VAS ]）、功能能力（匹兹堡睡眠质量指数[PSQI]）、抑郁情况（贝克抑郁量表[BDI]）、刺激参数以及与硬件和/或刺激相关的不良事件。
总体VAS（t = 66.76，p < 0.001）和VAS（t = 4.763，p < 0.049；p < 0.001）随时间下降。爆发式显著降低VAS达87.5%（±17.7）（平均从8 ± 0.76降至1 ± 1.41；t =12.3，p < 0.001），10千赫兹显著降低VAS达54.9%（±44）（平均从8 ± 0.63降至3.5 ± 3.27；t =3.09，p = 0.027）。未发现两种SCS类型之间存在显著差异（t =1.75，p = 0.13）。爆发式对VAS有显著抑制作用（爆发式：从3.6 ± 1.59降至1.5 ± 1.06；t = 3.32，p = 0.013）。发现时间对功能结局有显著影响，且两种SCS类型之间无显著差异（PSQI：t = 8.8，p = 0.012；BDI：t = 53.3，p < 0.001）。未发生与刺激/硬件相关的并发症。
这项比较研究的长期数据表明，在我们的小规模队列中，爆发式的反应性优于10千赫兹，因此强烈建议进行更大规模的随机对照比较研究设计。
