Timothy R Deer1, Robert M Levy2, Jeffery Kramer3,4, Lawrence Poree5, Kasra Amirdelfan6, Eric Grigsby7, Peter Staats8, Abram H Burgher9, James Scowcroft10, Stan Golovac11, Leonardo Kapural12, Richard Paicius13, Jason E Pope14, Sam Samuel15, William Porter McRoberts16, Michael Schaufele17, Allen W Burton18, Adil Raza18, Filippo Agnesi18, Nagy Mekhail15. 1. Center for Pain Relief, Charleston, WV, USA. 2. Neuromodulation Institute, Boca Raton, FL, USA. 3. Volta Research, USA. 4. University of Illinois, College of Medicine, IL, USA. 5. University of California at San Francisco, San Francisco, CA, USA. 6. IPM Medical Group, Inc., Walnut Creek, CA, USA. 7. Neurovations, Napa, CA, USA. 8. Premier Pain Center, Shrewsbury Township, NJ, USA. 9. HOPE Research - TPC, Phoenix, AZ, USA. 10. Pain Management Associates, Independence, MO, USA. 11. Florida Pain, Merritt Island, FL, USA. 12. Carolinas Pain Institute, Winston-Salem, NC, USA. 13. Newport Beach Headache and Pain, Newport Beach, CA, USA. 14. Evolve Restorative Center, Santa Rosa, CA, USA. 15. Cleveland Clinic, Cleveland, OH, USA. 16. Holy Cross Hospital, Ft. Lauderdale, FL, USA. 17. Drug Studies America, Marietta, GA, USA. 18. Abbott Neuromodulation, Plano, TX, USA.
Abstract
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.
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.
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