Trial reportRegional anesthesia and pain medicine2026
Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 12-month results from the COMFORT-randomized controlled trial.
Trial report in Regional anesthesia and pain medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05287373 (Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain), which is not on this map. Cited by 6 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain
Who cites it
6 citing papers in PubMed.
- Article
- A novel single-lead percutaneous approach for multi-nerve peripheral stimulation in upper extremity pain: A case report.Interventional pain medicine · 2025Article
- Consensus Guidelines from the American Society of Pain and Neuroscience for the Use of 60-Day Peripheral Nerve Stimulation Therapy. A NEURON Living Guideline Project.Journal of pain research · 2025Article
- Real-world healthcare utilization and costs of peripheral nerve stimulation with a micro-IPG system.Pain management · 2025Observational
- The effect of enhanced external counterpulsation on anxiety and depression in patients with paroxysmal atrial fibrillation: a randomized controlled trial.Frontiers in cardiovascular medicine · 2025Article
- Consensus Guidelines for the Use of Peripheral Nerve Stimulation in the Treatment of Chronic Pain and Neurological Diseases: A Neuron Project from the American Society of Pain and Neuroscience.Journal of pain research · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 NUMBER: NCT05287373.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.