Hatheway John, Hersel Alexander, Engle Mitchell, Gutierrez Genaro, Khemlani Vishal, Kapural Leonardo, Moore Gregory, Ajakwe Reginald, Trainor Drew, Hah Jennifer, Staats Peter S, Makous James, Heit Gary, Kottalgi Shilpa, Desai Mehul J
Pain Management, Northwest Pain Care, Spokane, Washington, USA.
Pain Management, Pain Management and Injury Relief, Thousand Oaks, California, USA.
Reg Anesth Pain Med. 2024 Nov 20. doi: 10.1136/rapm-2024-106099.
There is paucity of data from randomized controlled trials supporting the use of peripheral nerve stimulation, a well-established therapy for the treatment of chronic pain. This study was undertaken, in part, to provide randomized controlled trial data in support of patient access to appropriate peripheral nerve stimulation therapy. The COMFORT study is the first large, postmarket, multicenter randomized controlled trials investigating the use of a Food and Drug Administration-cleared micro-implantable pulse generator (IPG) for treating chronic pain via peripheral nerve stimulation therapy.
Consented, eligible subjects were randomized to either the active arm, which received peripheral nerve stimulation and conventional medical management, or the control arm, which received conventional medical management alone and were allowed to cross over to the active arm, after 3 months. Pain and patient-reported outcomes were captured. Therapy responders were subjects who achieved at least a 50% reduction in pain scores compared with baseline. We are reporting the 12-month results of this 36-month study.
At 12 months, the responder rate was 87% with a 69% average reduction in pain compared with baseline (7.5±1.2 to 2.3±1.7; p<0.001). Statistical significance was achieved for all patient-reported outcomes. There was an excellent safety profile with no serious adverse device effects or reports of pocket pain. A majority of subjects used unique programming options and found this device easy to use and comfortable to wear.
These 12-month results are consistent with previously reported 6-month outcomes from this study, showing durability of peripheral nerve stimulation treatment with the micro-IPG system; subjects realized sustained large reduction in pain and improvement in patient-reported outcomes following treatment with this micro-IPG system.
NCT05287373.
支持使用外周神经刺激（一种成熟的慢性疼痛治疗方法）的随机对照试验数据匮乏。本研究部分目的是提供随机对照试验数据，以支持患者获得适当的外周神经刺激治疗。COMFORT研究是第一项大型的上市后多中心随机对照试验，旨在研究使用美国食品药品监督管理局批准的微型植入式脉冲发生器（IPG）通过外周神经刺激疗法治疗慢性疼痛。
获得同意的合格受试者被随机分为活性组，接受外周神经刺激和传统药物治疗，或对照组，仅接受传统药物治疗，并在3个月后可交叉至活性组。记录疼痛和患者报告的结果。治疗反应者是指与基线相比疼痛评分至少降低50%的受试者。我们报告的是这项为期36个月研究的12个月结果。
在12个月时，反应率为87%，与基线相比疼痛平均降低69%（7.5±1.2至2.3±1.7；p<0.001）。所有患者报告的结果均具有统计学意义。安全性良好，无严重不良器械效应或囊袋疼痛报告。大多数受试者使用了独特的编程选项，发现该设备易于使用且佩戴舒适。
这些12个月的结果与本研究先前报告的6个月结果一致，表明微型IPG系统的外周神经刺激治疗具有持久性；使用该微型IPG系统治疗后，受试者疼痛持续大幅减轻，患者报告的结果得到改善。
NCT05287373。
