可注射脊髓刺激系统:初步研究

Laura Tyler Perryman MS, MBA, Benjamin Speck MS, Carlos Montes Garcia MD, Ralph Rashbaum MD
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引用次数: 12

摘要

脊髓刺激(SCS)被广泛用于缓解慢性背部和肢体疼痛。然而,许多不良事件对扩大治疗的可接受性构成了障碍。进行了一项前瞻性、非随机队列研究,以比较无线供电的新型SCS系统与商用SCS系统的疗效。12例患者依次植入美敦力1 × 8 SCS试验导联和刺激波自由试验导联,进行为期1天的评估。患者被要求报告疼痛缓解、感觉异常覆盖、感觉异常强度和感觉异常舒适度。12例患者中有10例成功进行了试验,而其余2例因手术设备故障而终止。在成功的患者中,所有人都报告了每个装置的良好疼痛缓解和感觉异常。据报道,刺激波系统的平均疼痛减轻率为80%,而美敦力系统的平均疼痛减轻率为66%。平均感觉异常覆盖率分别为91%和77%。患者报告的平均值差异可归因于研究中没有设计随机化。研究表明,无线供电的、可注射的SCS系统在缓解疼痛和为患有慢性背部和肢体疼痛的患者创造感觉异常覆盖方面与商业产品一样有效,并且在试验期间具有缩短手术时间和消除开放端口的额外优势,以及消除了为植入式脉冲发生器建立隧道和口袋的需要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Injectable spinal cord stimulator system: Pilot study

Spinal cord stimulation (SCS) is widely used for relief of chronic back and limb pain. However, numerous adverse events pose a hindrance to the widened acceptability of the treatment. A prospective, nonrandomized cohort study was conducted to compare the efficacy of a wirelessly powered SCS novel system with commercial SCS systems. Each of 12 patients were serially implanted with a Medtronic 1 × 8 SCS trial lead and a Stimwave Freedom trial lead for a 1-day evaluation. Patients were asked to report on pain relief, paresthesia coverage, paresthesia intensity, and paresthesia comfort. Ten of the 12 patients successfully underwent the trial whereas the remaining 2 procedures were terminated because of operating-equipment failures. Of the successful patients, all reported good pain relief and paresthesia for each device. The average pain reduction was reported as 80% for the Stimwave system and 66% for the Medtronic system. The average paresthesia coverage was 91% and 77%, respectfully. Differences in the averages reported by patients can be attributed to the fact that no randomization was designed in the study. The study showed that wirelessly powered, injectable SCS systems are just as effective as commercial products at relieving pain and at creating paresthesia coverage for patients who suffer from chronic back and limb pain and have the added advantages of shortened procedure time and elimination of open ports during the trial periods, as well as elimination of the need for tunneling and pocket creation for implantable pulse generators.

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