Sustained effectiveness of 10 kHz high-frequency spinal cord stimulation for patients with chronic, low back pain: 24-month results of a prospective multicenter study.
Sustained effectiveness of 10 kHz high-frequency spinal cord stimulation for patients with chronic, low back pain: 24-month results of a prospective multicenter study.
复制标题
DOI：
10.1111/pme.12294
复制
发表时间：
2014-03
期刊：
影响因子：
--
通讯作者：
Smith T
中科院分区：
文献类型：
--
作者：
Al-Kaisy A;Van Buyten JP;Smet I;Palmisani S;Pang D;Smith T
本研究的目的是研究无感觉异常高频脊髓刺激（HF 10 SCS）治疗慢性顽固性腰痛和下肢疼痛的长期有效性和安全性。前瞻性、多中心、观察性研究。患有严重慢性腰痛的患者植入了能够进行HF 10 SCS的脊髓刺激器。对患者的疼痛评分、残疾、睡眠障碍、阿片类药物使用、满意度和不良事件进行了24个月的评估。试验期后，88%（72/82）的患者报告疼痛评分显著改善，并接受了该系统的永久植入。90%（65/72）的患者参加了24个月的随访访视。平均背痛从基线时的8.4 ± 0.1减轻到24个月时的3.3 ± 0.3（P < 0.001），平均腿痛从5.4 ± 0.4减轻到2.3 ± 0.3（P < 0.001）。伴随疼痛缓解，阿片类药物使用、奥斯韦斯特里残疾指数评分和睡眠障碍显著减少。患者的满意度和推荐度都很高。不良事件的类型和频率与传统SCS系统观察到的相似。在慢性腰痛患者中，HF 10 SCS导致临床显著和持续的背痛和腿痛缓解、功能和睡眠改善、阿片类药物使用减少和患者满意度高。这些结果支持HF 10 SCS的长期安全性和持续有效性。
The aim of this study was to investigate the long-term efficacy and safety of paresthesia-free high-frequency spinal cord stimulation (HF10 SCS) for the treatment of chronic, intractable pain of the low back and legs. Prospective, multicenter, observational study. Patients with significant chronic low back pain underwent implantation of a spinal cord stimulator capable of HF10 SCS. Patients' pain ratings, disability, sleep disturbances, opioid use, satisfaction, and adverse events were assessed for 24 months. After a trial period, 88% (72 of 82) of patients reported a significant improvement in pain scores and underwent the permanent implantation of the system. Ninety percent (65 of 72) of patients attended a 24-month follow-up visit. Mean back pain was reduced from 8.4 ± 0.1 at baseline to 3.3 ± 0.3 at 24 months (P < 0.001), and mean leg pain from 5.4 ± 0.4 to 2.3 ± 0.3 (P < 0.001). Concomitantly to the pain relief, there were significant decreases in opioid use, Oswestry Disability Index score, and sleep disturbances. Patients' satisfaction and recommendation ratings were high. Adverse Events were similar in type and frequency to those observed with traditional SCS systems. In patients with chronic low back pain, HF10 SCS resulted in clinically significant and sustained back and leg pain relief, functional and sleep improvements, opioid use reduction, and high patient satisfaction. These results support the long-term safety and sustained efficacy of HF10 SCS.
登录
查看更多内容
影响因子：
2.8
作者：
Tiede, Jeffrey;Brown, Lora;Morgan, Donna
通讯作者：
Morgan, Donna
影响因子：
4.8
作者：
NORTH, RB;KIDD, DH;YOUNG, RF
通讯作者：
YOUNG, RF
影响因子：
158.5
作者：
Benson, K;Hartz, AJ
通讯作者：
Hartz, AJ
影响因子：
2.6
作者：
Sator-Katzenschlager, Sabine;Fiala, Katharina;Likar, Rudolf
通讯作者：
Likar, Rudolf
影响因子：
2.8
作者：
Navarro, Rosa M.;Vercimak, Danika C.;Raso, Louis
通讯作者：
Raso, Louis