Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 12-month results from the COMFORT-randomized controlled trial
Abstract
Background 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. Methods 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. Results 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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