• John Hatheway, Alexander Hersel, Mitchell Engle, Genaro Gutierrez, Vishal Khemlani, Leonardo Kapural, Gregory Moore, Reginald Ajakwe, Drew Trainor, Jennifer Hah, Peter S Staats, James Makous, Gary Heit, Shilpa Kottalgi, Mehul J Desai, and COMFORT Study Group.
• Pain Management, Northwest Pain Care, Spokane, Washington, USA.
• Reg Anesth Pain Med. 2024 Nov 20.

BackgroundThere 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.MethodsConsented, 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.ResultsAt 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.ConclusionsThese 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.Trial Registration NumberNCT05287373.© American Society of Regional Anesthesia & Pain Medicine 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.

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