Comparison of Paresthesia Coverage of Patient's Pain: Dorsal Root Ganglion vs. Spinal Cord Stimulation. An ACCURATE Study Sub‐Analysis

Objectives This was a sub‐analysis of the ACCURATE clinical trial that evaluated the accuracy and necessity of targeting paresthesia coverage of painful areas with dorsal root ganglion (DRG) stimulation vs. tonic spinal cord stimulation (SCS). Materials and Methods On diagrams of the torso and lower...

Full description

Saved in:
Bibliographic Details
Published inNeuromodulation (Malden, Mass.) Vol. 22; no. 8; pp. 930 - 936
Main Authors Deer, Timothy R., Levy, Robert M., Kramer, Jeffery, Poree, Lawrence, Amirdelfan, Kasra, Grigsby, Eric, Staats, Peter, Burgher, Abram H., Scowcroft, James, Golovac, Stan, Kapural, Leonardo, Paicius, Richard, Pope, Jason E., Samuel, Sam, Porter McRoberts, William, Schaufele, Michael, Burton, Allen W., Raza, Adil, Agnesi, Filippo, Mekhail, Nagy
Format Journal Article
LanguageEnglish
Published United States Elsevier Limited 01.12.2019
Subjects
Online AccessGet full text
ISSN1094-7159
1525-1403
1525-1403
DOI10.1111/ner.12920

Cover

More Information
Summary:Objectives This was a sub‐analysis of the ACCURATE clinical trial that evaluated the accuracy and necessity of targeting paresthesia coverage of painful areas with dorsal root ganglion (DRG) stimulation vs. tonic spinal cord stimulation (SCS). Materials and Methods On diagrams of the torso and lower limbs, subjects marked where they felt pain at baseline and paresthesias at three months postimplant. Seventy‐five subjects (41 DRG and 34 SCS) with diagrams of sufficient quality were scanned, digitized, and included in this analysis. Subject completed diagrams were digitized and superimposed with a grid of 1398 squares. Quantification of the percentage of bodily areas affected by pain and stimulation induced paresthesias was performed. Results The percent of painful areas covered by paresthesia was significantly lower for DRG subjects than for SCS subjects (13% vs. 28% of the painful regions, p < 0.05), possibly because significantly more DRG subjects felt no paresthesia during stimulation when compared to SCS subjects (13/41 DRG vs. 3/34 SCS) (p < 0.05). The amount of paresthesia produced outside the painful areas (unrequired paresthesia) was significantly lower in DRG subjects than that of SCS subjects. On average, the percent of unrequired paresthesia was only 20% of the subjects' total painful body surface area in the DRG group compared to 210% in the SCS group (p < 0.01). Conclusions The results of this ACCURATE study sub‐analysis show that DRG stimulation produces paresthesias, on average, that are less frequent, less intense, with a smaller footprint on the body and less dependent on positional changes.
Bibliography:Conflict of Interest
Drs. Mekhail, Deer, Poree, Amirdelfan, Grigsby, Staats, Burton, Burgher, Scowcroft, Golovac, Kapural, Paicius, Pope, Samuel, McRoberts, Schaufele, and Levy were paid by Spinal Modulation & St. Jude Medical as investigators for the ACCURATE study. Dr. Levy has served as a consultant to Bioness, Bluewind Medical, Boston Scientific, Flowonix, Medtronic, Microtransponder, Nevro, Saluda Medical, Spinal Modulation, and Abbott. Dr. Levy is or has been a minority shareholder in Saluda Medical, Spinal Modulation, Bioness, Vertos and Nevro. Dr. Mekhail formerly had a consultation agreement with Spinal Modulation to serve as medical monitor of the ACCURATE study. Currently he is a consultant for Abbott, Saluda Medical, StimWave, Medtronic Neurological and Flowonix. Dr. Amirdelfan is a consultant for Nevro, Saluda Medical, Nalu Medical, Biotronik and ENSO. Dr. Scowcroft has served as a consultant for Abbott and Boston Scientific. Dr. Kapural is a consultant for Abbott, Nevro, Neuros, SPR Therapeutics, and Saluda Medical. Dr. Paicius is a consultant for Abbott, Nuvectra, Mesoblast, Vertiflex, Vertos, and Pacific Stem Cells. Dr. Pope is a consultant for Abbott, Flowonix, Saluda Medical, Jazz Pharmaceuticals, SPR Therapeutics, and Vertiflex. Dr. McRoberts serves or has served as a consultant for Abbott, Medtronic, Nevro, Boston Scientific, Bioness, Vertiflex, and SPR Therapeutics. Dr. Deer is a consultant for Axonics, Bioness, Flowonix, Jazz Pharma, Abbott, Saluda Medical, Vertos, SpineThera, Mainstay, Nalu, and Vertiflex. Dr. Deer has equity options in Bioness, Vertiflex, Axonic, Vertos, SpineThera, Saluda Medical, Nalu, Cornerloc and Flowonix. He is research consultant for Mainstay Medical. Dr. Deer formerly had equity positions in Spinal Modulation and Nevro. Dr. Kramer is a consultant for Abbott, Nalu Medical, Autonomic Technologies, Thimble Bioelectronics, Circuit Therapeutics, and CereVu. Dr. Kramer has equity in Abbott as a former employee, and formerly had equity in Spinal Modulation. Dr. Burton, Dr. Agnesi, and Mr. Raza receive salary and have equity as employees of Abbott. The remaining authors report no conflicts of interest.
ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 14
ObjectType-Article-2
ObjectType-Feature-1
content type line 23
ObjectType-Undefined-3
ISSN:1094-7159
1525-1403
1525-1403
DOI:10.1111/ner.12920