Design of a Multicenter, Randomized Controlled Trial for the Treatment of Peripheral Neuropathic Pain (COMFORT Study) with a Micro-Implantable Pulse Generator
The COMFORT study, described here, has the potential to demonstrate the efficacy and safety of the Nalu Neurostimulation System in the treatment of peripheral neuropathy. Results of this study will be the first Level-I evidence, out to 36 months, validating the use of this PNS system in the treatment of chronic pain. This study is designed to enroll the largest cohort, to date, of subjects comparing PNS+CMM vs CMM alone.
Authors
- Jennifer M. Hah (ORCID: https://orcid.org/0000-0002-9739-3968)
- Mitchell Engle
- Gary Heit
- Vishal Khemlani
- Reginald Ajakwe
- John Hatheway (ORCID: https://orcid.org/0000-0002-9551-2150)
- Shilpa Kottalgi (ORCID: https://orcid.org/0000-0001-6686-3587)
- Mehul J. Desai (ORCID: https://orcid.org/0000-0001-6870-9436)
- Leonardo Kapural (ORCID: https://orcid.org/0000-0003-2718-5837)
- Drew M Trainor
- Peter S. Staats (ORCID: https://orcid.org/0000-0002-4079-5165)
- James Makous
- Paul Lynch (ORCID: https://orcid.org/0000-0002-4219-876X)
- Genaro Gutierrez
- Alexander Hersel
- Gregory Moore
- Jonathan Song
Institutions
- Pain Management Institute (US)
- Hue University (VN)
- Cancer Care Northwest (US)
- Medical Advanced Pain Specialists (US)
- Carolinas Pain Institute (US)
- Arizona Pain Specialists (US)
- Pain Cure Center (US)
- Pain Management Centers Of America (US)
- International Spine, Pain & Performance (US)
- Pain and Rehabilitation Medicine (US)
Publication Details
- Journal
- Journal of Pain Research
- Published
- 2024-09-01
- DOI
- https://doi.org/10.2147/jpr.s460563
- Citations
- 1
- Primary Topic
- Pain Management and Treatment
- Type
- article
- Field-Weighted Citation Impact
- 0.64