Long-Term Pain Relief Delivered by Micro-Implantable Pulse Generator: Findings from a Large-Scale, Real-World Data Peripheral Nerve Stimulation Patient Registry
Year: 2025
Type: article
Study design: Observational Study
Abstract: Introduction: Peripheral Nerve Stimulation (PNS) is an established modality for treating chronic peripheral neuralgia/ neuropathy.Recent data from the COMFORT RCT demonstrated significant, sustained long-term improvements.Real-world evidence may confirm these outcomes, provide clinical practice insights, and enable comparison with RCT data.This work represents the largest, long-term report of Real-World Data (RWD) on patients with a permanent PNS implant.Methods: Anonymized records were reviewed from a national real-world, Institutional Review Board (IRB) approved registry of patients implanted between 12/8/2021 and 3/06/2024.Data consisted of standardized Patient Global Impression of Change (PGIC) responses.Surveys were completed following permanent implantation of a micro-IPG PNS system.A responder was defined as those achieving the Minimal Clinically Important Difference (MCID) for PGIC.Results: A total of 2,273 patients were included in this analysis.Major anatomic regions treated were head/neck 7% (158/2,273), trunk 42.8% (973/2,273), upper extremity 14.1% (321/2,273), and lower extremity 36.1% (821/2,273).Sixty primary nerve targets and/or nerve combinations were treated.The responder rate was 94% (2,137/2,273) for all patients.Sixty-five percent reported "Very Much Improved" or "Much Improved", 29% reported "Minimally Improved", 4% reported "No Change" and 1% reported any worsening.Response rates were consistent across all anatomic targets.Conclusions: These real-world results confirm the COMFORT PNS RCT findings of long-term improvements and demonstrate generalizability of the data from that RCT.Additional data from this registry will be reported as it becomes available.
Source: Chronic Pain & Management
Authors: John A Hatheway, Tim Ratino, AR Swain, Thomas Ratino, Usman Latif, Sailesh Arulkumar, Mehul J Desai
Institution: The University of Kansas Health System
Language: English
Subfield: Anesthesiology and Pain Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4410059458