Abstract：
OBJECTIVE: High-frequency spinal cord stimulation (10-kHz SCS) has been shown to be an effective treatment for refractory low back pain and neck pain with and without limb pain in clinical trial and real-world studies. However, limited information is available in the literature on the type and frequency of programming parameters required to optimize pain relief.
METHODS: Retrospective trial and postimplant clinical and system device data were analyzed from consecutive patients with neck pain and low back pain, with and without limb pain, from a single clinical site, including both thoracic and cervical lead placement. Best bipole, stimulation parameters, and outcomes, including pain relief, change in opioid medication use, sleep, and daily function, were analyzed.
RESULTS: Of the 92 patients in the trial, 70 received a permanent implant. Of these, the mean duration of follow-up was 1.8 ± 1.3 years. Pain relief of ≥50% at the last follow-up was achieved by 64% of patients implanted; in addition, 65% reduced their opioid medication use; 65% reported improved sleep, and 71% reported improved function. There was some consistency between the \"best\" bipole at trial and permanent implant, with 82% of patients within one bipole location, including 54% of permanent implants who were using the same best bipole as at trial. After permanent implant, device reprogramming was minimal, with ≤one reprogramming change per patient per quarter required to maintain pain outcomes.
CONCLUSIONS: In the study, 10-kHz SCS was an effective therapy for treating chronic pain, whereby a high responder rate (≥50% pain relief) was achieved with short time to pain relief in trial and maintained with limited device programming after permanent implant. The data presented here provide insight into the programming required during the trial and implant stages to obtain and maintain therapeutic efficacy.
METHODS: Retrospective trial and postimplant clinical and system device data were analyzed from consecutive patients with neck pain and low back pain, with and without limb pain, from a single clinical site, including both thoracic and cervical lead placement. Best bipole, stimulation parameters, and outcomes, including pain relief, change in opioid medication use, sleep, and daily function, were analyzed.
RESULTS: Of the 92 patients in the trial, 70 received a permanent implant. Of these, the mean duration of follow-up was 1.8 ± 1.3 years. Pain relief of ≥50% at the last follow-up was achieved by 64% of patients implanted; in addition, 65% reduced their opioid medication use; 65% reported improved sleep, and 71% reported improved function. There was some consistency between the \"best\" bipole at trial and permanent implant, with 82% of patients within one bipole location, including 54% of permanent implants who were using the same best bipole as at trial. After permanent implant, device reprogramming was minimal, with ≤one reprogramming change per patient per quarter required to maintain pain outcomes.
CONCLUSIONS: In the study, 10-kHz SCS was an effective therapy for treating chronic pain, whereby a high responder rate (≥50% pain relief) was achieved with short time to pain relief in trial and maintained with limited device programming after permanent implant. The data presented here provide insight into the programming required during the trial and implant stages to obtain and maintain therapeutic efficacy.
摘要：
目的：在临床试验和现实世界研究中，高频脊髓刺激（10-kHzSCS）已被证明是治疗伴有和不伴有肢体疼痛的难治性下腰痛和颈痛的有效方法。然而,有关优化疼痛缓解所需的编程参数的类型和频率的文献信息有限。
方法：回顾性试验和移植后的临床和系统设备数据从连续的颈部疼痛和下腰痛患者进行分析，有和没有四肢疼痛，从一个临床站点，包括胸和颈导联放置。最好的双极,刺激参数，和结果，包括疼痛缓解,阿片类药物使用的变化，睡眠,和日常功能，进行了分析。
结果：在该试验的92名患者中，70人接受了永久性植入物。其中,平均随访时间为1.8±1.3年.最后一次随访时疼痛缓解≥50％的患者植入了64％;此外，65%的人减少了阿片类药物的使用；65%的人报告说睡眠有所改善。71%的人报告功能有所改善。试验中的“最佳”双极和永久性植入物之间有一定的一致性，82%的患者在一个双极位置，包括54％的永久性植入物使用与试验时相同的最佳双极。永久植入后，设备重新编程是最小的，为维持疼痛结局，每位患者每季度需要进行≤一次重编程更改。
结论：在研究中，10-kHzSCS是治疗慢性疼痛的有效疗法，由此,在试验中疼痛缓解时间较短,并在永久性植入后通过有限的器械编程维持较高的应答率(疼痛缓解≥50%)。此处提供的数据提供了对在试验和植入阶段获得和维持治疗功效所需的编程的见解。
方法：回顾性试验和移植后的临床和系统设备数据从连续的颈部疼痛和下腰痛患者进行分析，有和没有四肢疼痛，从一个临床站点，包括胸和颈导联放置。最好的双极,刺激参数，和结果，包括疼痛缓解,阿片类药物使用的变化，睡眠,和日常功能，进行了分析。
结果：在该试验的92名患者中，70人接受了永久性植入物。其中,平均随访时间为1.8±1.3年.最后一次随访时疼痛缓解≥50％的患者植入了64％;此外，65%的人减少了阿片类药物的使用；65%的人报告说睡眠有所改善。71%的人报告功能有所改善。试验中的“最佳”双极和永久性植入物之间有一定的一致性，82%的患者在一个双极位置，包括54％的永久性植入物使用与试验时相同的最佳双极。永久植入后，设备重新编程是最小的，为维持疼痛结局，每位患者每季度需要进行≤一次重编程更改。
结论：在研究中，10-kHzSCS是治疗慢性疼痛的有效疗法，由此,在试验中疼痛缓解时间较短,并在永久性植入后通过有限的器械编程维持较高的应答率(疼痛缓解≥50%)。此处提供的数据提供了对在试验和植入阶段获得和维持治疗功效所需的编程的见解。
