PowerPoint Presentation
Advanced Peripheral Nerve Stimulator Delivers Consistent Pain Relief Across Various Neuropathic Etiologies: COMFORT RCT Findings
Authors: J. Hatheway, M. Engle, A. Hersel, G. Gutierrez, V. Khemlani, L. Kapural, G. Moore, R. Ajakwe, D. Trainor, JM Hah, S. Kottalgi; MJ Desai
Affiliations: Northwest Pain Care, WA; Institute of Precision Pain Medicine, TX; Pain Relief & Injury Management, CA; Pain Specialists of America, TX; Columbia Pain Management, OR; Carolinas Pain Institute, NC; Pacific Sports and Spine, OR; Comprehensive Spine & Pain Physicians, CA; DBPS Research, LLC; Stanford Medicine, CA; Nalu Medical, Inc., Carlsbad, CA; International Spine, Pain & Performance Center, DC.
| INTRODUCTION | METHODS |
|---|---|
| - Peripheral Neuropathic Pain (PNP) may require interventional treatment beyond conservative methods; Peripheral Nerve Stimulation (PNS) is an option. | - Eligible subjects had one of the mentioned etiologies in the knee, low back, shoulder and foot/ankle. |
| - The COMFORT study enrolled subjects with various chronic pain etiologies and diagnoses: - Post-traumatic - Post-surgical - Mononeuropathy - Osteoarthritis (OA) - Peripheral neuropathy | - Subjects randomized to - PNS + Conventional Medical Management (CMM), or - CMM alone - PNS delivered using a battery-free micro-Implantable Pulse Generator (IPG) with complex programming capabilities. |
6-Month Outcomes (n=60)
| Baseline | n | Average Pain score (NRS) | Responder Rate | Avg Pain Relief |
|---|---|---|---|---|
| Group 1 | 23 | 7.52 | 91% | 73% |
| Group 2 | 13 | 7.53 | 69% | 64% |
| Group 3 | 14 | 7.12 | 79% | 67% |
| Group 4 | 8 | 7.88 | 88% | 69% |
| Group 5 | 2 | 7.66 | 50% | 56% |
12-Month Outcomes (n=61)
| Average Pain score (NRS) | n | Responder Rate | Avg Pain Relief |
|---|---|---|---|
| Group 1 | 23 | 1.91 | 91% |
| Group 2 | 12 | 2.67 | 92% |
| Group 3 | 15 | 2.80 | 73% |
| Group 4 | 8 | 1.88 | 88% |
| Group 5 | 3 | 2.67 | 100% |
CONCLUSIONS
- Significant and sustained pain relief across various peripheral chronic pain conditions with PNS.
- Patients experienced high responder rates and pain reductions, sustained at both 6 and 12 months, irrespective of etiology of pain.
- Broad applicability and long-term effectiveness of PNS, establishing the micro-IPG as a versatile tool for managing diverse pain types.
Hatheway J, Hersel A, Engle M, et al. Reg Anesth Pain Med Epub 2024 doi: 10.1136/rapm-2024-106099.
Hatheway Reg Anesth Pain Med 2024;0:1-7. doi:10.1136/rapm-2023-105264.