Haider Nameer, Ligham Dwight, Quave Brett, Harum Kirk E, Garcia Eduardo A, Gilmore Christopher A, Miller Nathan, Moore Gregory A, Bains Amarpreet, Lechleiter Kristen, Jain Roshini
Spine and Skeletal Pain Medicine, Utica, NY, USA.
Advanced Diagnostic Pain Treatment Centers, New Haven, CT, USA.
Neuromodulation. 2018 Jul;21(5):504-507. doi: 10.1111/ner.12783. Epub 2018 Jun 11.
Spinal cord stimulation (SCS) for chronic intractable pain is typically delivered in pulses, classically programmed between approximately 20 and 100 Hz. Though some recent studies suggest that better pain relief is obtained, with only 10 kHz stimulation, other studies show that single-therapy trials do not always lead to permanent implantation. We evaluated SCS outcomes in subjects given trials with multiple waveforms who did not experience satisfactory trial relief with 10 kHz stimulation only.
In this multicenter, open-label, real-world, observational study conducted in the United States, subjects reporting <50% pain relief with 10 kHz stimulation (i.e., failed the screening trial) received a stimulator capable of delivering multiple waveforms and/or field shapes. Pain relief and patient device preference data were collected.
Twenty-two subjects were analyzed. Of the 16 who failed the 10 kHz trial and had numerical rating scale, visual analog scale, or percent pain relief scores available, 63% (n = 10) reported ≥50% relief with multiple waveform SCS. Additionally, 80% of subjects with ≥50% relief using multiple waveform SCS had experienced no relief with 10 kHz SCS. Among all subjects, 68% preferred multiple waveform SCS, none preferred 10 kHz SCS, and 32% had no preference.
Subjects with failed SCS trials at 10 kHz experienced ≥50% relief after switching to a multiple waveform system. These results suggest that providing multiple waveforms during trials may overcome limitations of providing only 10 kHz stimulation. Thus, chronic pain's variable nature across patients and over time lends itself to variable treatment options.
用于慢性顽固性疼痛的脊髓刺激（SCS）通常以脉冲形式进行，传统的编程频率在大约20至100赫兹之间。尽管最近一些研究表明，仅采用10千赫兹刺激可获得更好的疼痛缓解效果，但其他研究表明，单疗法试验并不总是能导致永久性植入。我们评估了在仅采用10千赫兹刺激未获得满意试验缓解效果的受试者中，给予多种波形试验的SCS结果。
在美国进行的这项多中心、开放标签、真实世界的观察性研究中，报告10千赫兹刺激疼痛缓解率<50%（即筛查试验失败）的受试者接受了能够提供多种波形和/或场形的刺激器。收集了疼痛缓解情况和患者对设备的偏好数据。
对22名受试者进行了分析。在16名10千赫兹试验失败且有数字评分量表、视觉模拟量表或疼痛缓解百分比分数的受试者中，63%（n = 10）报告多种波形SCS的缓解率≥50%。此外，使用多种波形SCS缓解率≥50%的受试者中，80%在10千赫兹SCS时未获得缓解。在所有受试者中，68%更喜欢多种波形SCS，没有人更喜欢10千赫兹SCS，32%没有偏好。
10千赫兹SCS试验失败的受试者在切换到多种波形系统后疼痛缓解率≥50%。这些结果表明，在试验期间提供多种波形可能会克服仅提供10千赫兹刺激的局限性。因此，慢性疼痛在患者之间以及随时间的变化性质适合采用多种治疗选择。
