IPM Medical Group, Inc., Walnut Creek, CA, USA.
Swedish Pain Center, Seattle, WA, USA.
Qual Life Res. 2018 Aug;27(8):2035-2044. doi: 10.1007/s11136-018-1890-8. Epub 2018 Jun 1.
Chronic axial low-back pain is a debilitating disorder that impacts all aspects of an afflicted individual's life. Effective, durable treatments have historically been elusive. Interventional therapies, such as spinal cord stimulation (SCS), have shown limited efficacy at best. Recently, a novel treatment, 10 kHz SCS, has demonstrated superior pain relief compared with traditional SCS in a randomized controlled trial (RCT). In this manuscript, we report on the long-term improvements in quality of life (QoL) outcomes for subjects enrolled in this study.
A prospective, multicenter, randomized controlled trial (SENZA-RCT) was conducted. Patients with both chronic back and leg pain were enrolled and randomized (1:1) into 10 kHz SCS or traditional SCS treatment groups. A total of 171 subjects received a permanent SCS device implant. QoL and functionality measures were collected up to 12 months. The device remote control utilization, which is an indication of patient interaction with the device for adjustments, was collected at 24-month post-implantation.
At 12 months, a higher proportion of 10 kHz SCS subjects had marked improvement of their disability (Oswestry Disability Index) to a "moderate" or "minimal" impact on their daily function versus the control group. The subjects also reported better improvement in the Global Assessment of Functioning, Clinician Global Impression of Change, Pittsburgh Sleep Quality Index, and short-form McGill Pain Questionnaire, compared to traditional SCS subjects. The 10 kHz SCS subjects also reported far higher rates of both driving and sleeping with their device turned on, as well as reduced reliance on their programmers to adjust therapy settings.
In addition to superior pain relief, 10 kHz SCS provides long-term improvements in quality of life and functionality for subjects with chronic low-back and leg pain.
ClinicalTrials.gov (NCT01609972).
慢性轴向腰痛是一种使人虚弱的疾病，会影响受影响个体生活的各个方面。有效的、持久的治疗方法一直难以捉摸。介入治疗，如脊髓刺激（SCS），效果最好也很有限。最近，一种新的治疗方法，10kHzSCS，在一项随机对照试验（RCT）中显示出比传统 SCS 更好的缓解疼痛效果。在本文中，我们报告了参与这项研究的受试者生活质量（QoL）长期改善的结果。
进行了一项前瞻性、多中心、随机对照试验（SENZA-RCT）。招募了患有慢性腰痛和腿痛的患者，并将其随机（1:1）分为 10kHzSCS 或传统 SCS 治疗组。共有 171 名患者接受了永久性 SCS 设备植入。在 12 个月内收集了 QoL 和功能测量结果。在植入后 24 个月，收集了设备遥控器的使用情况，这是患者对设备进行调整的互动的一个指标。
在 12 个月时，与对照组相比，10kHzSCS 组有更高比例的患者残疾（Oswestry 残疾指数）显著改善，对其日常功能的影响为“中度”或“轻度”。与传统 SCS 组相比，患者还报告了更好的总体功能改善、临床医生对变化的总体印象、匹兹堡睡眠质量指数和简短形式麦吉尔疼痛问卷。10kHzSCS 组还报告说，他们打开设备驾驶和睡眠的比例更高，以及对调整治疗设置的依赖程度降低。
除了更好的缓解疼痛外，10kHzSCS 还为慢性下腰痛和腿痛患者提供了长期的生活质量和功能改善。
ClinicalTrials.gov（NCT01609972）。
