Objective

Spinal cord stimulation (SCS) has become a common treatment modality for chronic pain of various etiologies. Over the past two decades, significant technological evolution has occurred in the SCS space, and this includes high-frequency (10 kHz) stimulation. Level I evidence exists reporting superiority of 10 kHz SCS over traditional SCS, however, conflicting reports have been published. The primary objective was to report site-collected real-world patient reported percentage improvement in pain scale (PR-PIPS) with traditional SCS and 10 kHz SCS from a single, academic medical center.

Materials and Methods

This study was a single-center retrospective review to determine PR-PIPS of traditional SCS and 10 kHz SCS in those patients implanted for at least 12 months. Data were collected by two independent physicians not involved with the implant surgery to minimize bias in the data collection process. PR-PIPS and other clinical variables were abstracted either via chart review or via phone call for patients who were at least 12 months post-implant at the last clinical follow-up.

Results

A total of 163 implanted patients (traditional stimulation n = 85; high-frequency stimulation n = 78) were identified. Twenty-two explants (traditional stimulation n = 10; high-frequency stimulation n = 12) were performed (13.5%). Seventy-five total remaining SCS implants utilizing traditional stimulation and 66 total remaining SCS implants utilizing high-frequency stimulation were included. There was no difference in PR-PIPS between traditional stimulation (50.6% ± 30.1%) and high-frequency stimulation (47.6% ± 31.5%) in the adjusted linear regression model in a variety of implant indications (p = 0.399). There was no difference in frequency of patient categorization into various thresholds of percentage pain relief based on type of stimulation. The most common reasons for explant were loss of efficacy (50.0%) and infection (40.0%) in the traditional cohort, and loss of efficacy (58.3%) in the high-frequency cohort.

Conclusions

This study adds further evidence to the published literature that successful long-term results can be achieved with SCS. Our retrospective analysis did not find a statistically significant difference in PR-PIPS between traditional stimulation and high-frequency stimulation in a variety of indications over an average follow-up of nearly two years. Notably, there were statistically significant differences in treatment indications and primary sites of pain between the two patient cohorts, and this should be considered when interpreting the results.

中文翻译：

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基于感觉异常与高频脊髓刺激：回顾性、真实世界、单中心比较

客观的

脊髓刺激（SCS）已成为各种病因的慢性疼痛的常见治疗方式。在过去的二十年中，SCS 领域发生了重大的技术发展，其中包括高频 (10 kHz) 刺激。存在 I 级证据报告 10 kHz SCS 优于传统 SCS，但是，已经发表了相互矛盾的报告。主要目标是报告现场收集的真实世界患者报告的疼痛量表 (PR-PIPS) 的百分比改善与传统 SCS 和 10 kHz SCS 从单个学术医疗中心。

材料和方法

这项研究是一项单中心回顾性研究，以确定植入至少 12 个月的患者的传统 SCS 和 10 kHz SCS 的 PR-PIPS。数据由两名未参与植入手术的独立医师收集，以尽量减少数据收集过程中的偏差。PR-PIPS 和其他临床变量通过图表审查或通过电话对最后一次临床随访时植入后至少 12 个月的患者进行抽象。

结果

共确定了 163 名植入患者（传统刺激n  = 85；高频刺激n  = 78）。进行了 22个外植体（传统刺激n  = 10；高频刺激n  = 12）（13.5%）。包括使用传统刺激的总共 75 个剩余 SCS 植入物和使用高频刺激的剩余 66 个 SCS 植入物。在各种种植体适应症的调整线性回归模型中，传统刺激（50.6% ± 30.1%）和高频刺激（47.6% ± 31.5%）的 PR-PIPS 没有差异（p = 0.399）。根据刺激类型，将患者分类为各种疼痛缓解百分比阈值的频率没有差异。外植体最常见的原因是传统队列中的功效丧失（50.0%）和感染（40.0%），以及高频队列中的功效丧失（58.3%）。

结论

这项研究为已发表的文献提供了进一步的证据，表明 SCS 可以取得成功的长期结果。我们的回顾性分析在近两年的平均随访中发现，在各种适应症中，传统刺激和高频刺激之间的 PR-PIPS 没有统计学上的显着差异。值得注意的是，两组患者的治疗适应症和主要疼痛部位存在统计学显着差异，在解释结果时应考虑这一点。