基于问卷的方法评估可充电体外脉冲发生器用于无线脊髓刺激的便利性。
Questionnaire-based approach to evaluate the convenience of rechargeable extracorporeal pulse generators for wireless spinal cord stimulation.
机构信息
Department of Neurosurgery, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Division of Surgical Pain Management, Department of Neurosurgery, University Hospital Heidelberg, Heidelberg, Germany.
出版信息
Sci Rep. 2022 May 17;12(1):8127. doi: 10.1038/s41598-022-11778-5.
Spinal cord stimulation (SCS) has been utilized for more than 50 years to treat refractory neuropathic pain. Currently, SCS systems with fully implantable pulse generators (IPGs) represent the standard. New wireless extracorporeal SCS (wSCS) devices without IPGs promise higher levels of comfort and convenience for patients. However, to date there are no studies on how charging and using this wSCS system affects patients and their therapy. This study is the first questionnaire-based survey on this topic focusing on patient experience. The trial was a single arm, open-label and mono-centric phase IV study. Standardized questionnaires were sent to all patients with a wSCS device in use at the time of trial. The primary endpoint was the convenience of the charging and wearing process scored on an ordinal scale from "very hard" (1) to "very easy" (5). Secondary endpoints included time needed for charging, the duration of stimulation per day and complication rates. Questionnaires of 6 out of 9 patients were returned and eligible for data analysis. The mean age of patients was 61.3 ± 6.7 (± SD) years. The duration of therapy was 20.3 ± 15.9 months (mean ± SD). The mean duration of daily stimulation was 17 ± 5.9 h (mean ± SD). n = 5 patients rated the overall convenience as "easy" (4) and n = 3 patients evaluated the effort of the charging process and wearing of the wSCS device as "low" (4). n = 5 patients considered the wearing and charging process as active participation in their therapy. n = 5 patients would choose an extracorporeal device again over a conventional SCS system. Early or late surgical complications did not occur in this patient collective. Overall, patients felt confident using extracorporeal wSCS devices without any complications. Effort to maintain therapy with this system was rated as low.
脊髓刺激 (SCS) 已经使用了超过 50 年,用于治疗难治性神经性疼痛。目前,具有完全可植入脉冲发生器 (IPG) 的 SCS 系统是标准治疗方式。新型无 IPG 的体外无线脊髓刺激 (wSCS) 设备为患者提供了更高水平的舒适度和便利性。然而,迄今为止,尚无研究表明使用这种 wSCS 系统对患者及其治疗有何影响。这项研究是首次针对该主题的基于问卷的调查,重点关注患者体验。该试验是一项单臂、开放标签和单中心的 IV 期研究。在试验时,所有使用 wSCS 设备的患者都收到了标准化问卷。主要终点是充电和佩戴过程的便利性,采用从“非常困难”(1)到“非常容易”(5)的顺序评分。次要终点包括充电所需时间、每天刺激持续时间和并发症发生率。9 名患者中有 6 名返回了问卷,且符合数据分析条件。患者的平均年龄为 61.3±6.7 岁(平均值±标准差)。治疗时间为 20.3±15.9 个月(平均值±标准差)。每天刺激的平均持续时间为 17±5.9 小时(平均值±标准差)。n=5 名患者总体上认为便利性为“容易”(4),n=3 名患者认为充电过程和佩戴 wSCS 设备的努力程度为“低”(4)。n=5 名患者认为佩戴和充电过程是他们治疗的积极参与。n=5 名患者会选择体外设备而不是传统的 SCS 系统。在这个患者群体中,没有发生早期或晚期手术并发症。总的来说,患者对使用体外 wSCS 设备充满信心,没有任何并发症。维持该系统治疗的努力程度被评为低。