Kapural Leonardo, Sayed Dawood, Kim Brian, Harstroem Caroline, Deering James
Carolinas Pain Institute, Winston-Salem, NC 27103, USA.
Department of Anesthesiology, University of Kansas, Kansas City, KS, USA.
J Pain Res. 2020 Nov 10;13:2861-2867. doi: 10.2147/JPR.S281749. eCollection 2020.
A randomized clinical trial demonstrated that 10 kHz SCS (10kHz-SCS) therapy is superior to traditional low-frequency SCS (LF-SCS) at 12- and 24-month clinical follow-ups and led to Food and Drug Administration (FDA) approval of the therapy. The results of the study led our practices to trial 10kHz-SCS in patients who had not maintained pain relief with LF-SCS therapy. Here, we report a large set of data from two clinical sites to assess if 10kHz-SCS is an effective salvage modality when LF-SCS fails.
We conducted a retrospective chart review of 120 patients across two clinical sites who had LF-SCS implants and were salvaged with 10kHz-SCS.
Data were analyzed from 105 patients between 28 and 90 years old (median 60) with chronic pain for 13.6 years. The mean duration of LF-SCS therapy was 4.66±3.9 years. The average Visual Analog Scale (VAS) decreased from 8.30±1.4 (median of 8) cm to 3.32±2.0 (median of 3) cm at 12 months and 3.36±2.0 (median of 3) cm at the most recent clinic visit (p<0.001) following salvage therapy. Pain relief of 50% or more was obtained in 85 out of 105 (81%) patients. Opioid usage decreased from 60.3±77.1 mg to 32.1±44.0 mg MSO4 equivalents (p = 0.001) at 12 months after salvage therapy.
Eighty-one percent of patient cases reviewed, where LF-SCS had failed, achieved >50% pain relief with 10kHz-SCS, and almost all exhibited some clinical improvement. Therefore, 10kHz-SCS should be considered an appropriate option to rescue failed LF-SCS.
一项随机临床试验表明，在12个月和24个月的临床随访中，10千赫兹脊髓刺激疗法（10kHz-SCS）优于传统低频脊髓刺激疗法（LF-SCS），并促使美国食品药品监督管理局（FDA）批准了该疗法。该研究结果促使我们的医疗团队在那些接受LF-SCS治疗后疼痛未得到缓解的患者中试用10kHz-SCS。在此，我们报告来自两个临床地点的大量数据，以评估当LF-SCS失败时，10kHz-SCS是否为一种有效的挽救治疗方式。
我们对两个临床地点的120例植入了LF-SCS并接受10kHz-SCS挽救治疗的患者进行了回顾性病历审查。
分析了105例年龄在28至90岁（中位数60岁）、患有慢性疼痛13.6年的患者的数据。LF-SCS治疗的平均持续时间为4.66±3.9年。在挽救治疗后的12个月时，平均视觉模拟评分（VAS）从8.30±1.4（中位数8）厘米降至3.32±2.0（中位数3）厘米，在最近一次门诊就诊时降至3.36±2.0（中位数3）厘米（p<0.001）。105例患者中有85例（81%）疼痛缓解达50%或更多。在挽救治疗后12个月，阿片类药物的使用量从60.3±77.1毫克降至32.1±44.0毫克硫酸吗啡当量（p = 0.001）。
在回顾的患者病例中，81%的患者在LF-SCS治疗失败后，通过10kHz-SCS实现了>50%的疼痛缓解，并且几乎所有患者都有一定的临床改善。因此，10kHz-SCS应被视为挽救失败的LF-SCS的合适选择。
