Nagy Mekhail1, Timothy R Deer2, Jeffery Kramer3, Lawrence Poree4, Kasra Amirdelfan5, Eric Grigsby6, Peter Staats7, Allen W Burton8, Abram H Burgher9, James Scowcroft10, Stanley Golovac11, Leonardo Kapural12, Richard Paicius13, Jason Pope14, Samuel Samuel1, William Porter McRoberts15, Michael Schaufele16, Alexander R Kent8, Adil Raza8, Robert M Levy17. 1. Evidence-based Pain Management Research Department, Cleveland Clinic, Cleveland, OH, USA. 2. Center for Pain Relief, Charleston, WV, USA. 3. Volta Research and University of Illinois College of Medicine, Chicago, IL, USA. 4. Department of Anesthesia, University of California, San Francisco, CA, USA. 5. IPM Medical Group, Inc., Walnut Creek, CA, USA. 6. Neurovations, Napa, CA, USA. 7. Premier Pain Center, Shrewsbury, NJ, USA. 8. Abbott Neuromodulation, Plano, TX, 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. Holy Cross Hospital, Ft. Lauderdale, FL, USA. 16. Drug Studies America, Marietta, GA, USA. 17. Marcus Neuroscience Institute, Boca Raton, FL, USA.
Abstract
INTRODUCTION: ACCURATE, a randomized controlled trial comparing dorsal root ganglion (DRG) stimulation to spinal cord stimulation, showed that DRG stimulation is a safe and effective therapy in individuals with lower extremity chronic pain due to complex regional pain syndrome (CRPS) type I or II. Investigators noted that DRG stimulation programming could be adjusted to minimize, or eliminate, the feeling of paresthesia while maintaining adequate pain relief. The present study explores treatment outcomes for DRG subjects who were paresthesia-free vs. those who experienced the sensation of paresthesia, as well as the factors that predicted paresthesia-free analgesia. METHODS: A retrospective analysis of therapy outcomes was conducted for 61 subjects in the ACCURATE study who received a permanent DRG neurostimulator. Outcomes of subjects who were paresthesia-free were compared to those who experienced paresthesia-present therapy at 1, 3, 6, 9, and 12-month follow-ups. Predictor variables for the presence or absence of paresthesias with DRG stimulation were also explored. RESULTS: The percentage of subjects with paresthesia-free pain relief increased from 16.4% at 1-month to 38.3% at 12-months. Paresthesia-free subjects generally had similar or better outcomes for pain severity, pain interference, quality of life, and mood state as subjects with paresthesia-present stimulation. Factors that increased the odds of a subject feeling paresthesia were higher stimulation amplitudes and frequencies, number of implanted leads, and younger age. CONCLUSIONS: Some DRG subjects achieved effective paresthesia-free analgesia in the ACCURATE trial. This supports the observation that paresthesia is not synonymous with pain relief or required for optimal analgesia with DRG stimulation.
INTRODUCTION: ACCURATE, a randomized controlled trial comparing dorsal root ganglion (DRG) stimulation to spinal cord stimulation, showed that DRG stimulation is a safe and effective therapy in individuals with lower extremity chronic pain due to complex regional pain syndrome (CRPS) type I or II. Investigators noted that DRG stimulation programming could be adjusted to minimize, or eliminate, the feeling of paresthesia while maintaining adequate pain relief. The present study explores treatment outcomes for DRG subjects who were paresthesia-free vs. those who experienced the sensation of paresthesia, as well as the factors that predicted paresthesia-free analgesia. METHODS: A retrospective analysis of therapy outcomes was conducted for 61 subjects in the ACCURATE study who received a permanent DRG neurostimulator. Outcomes of subjects who were paresthesia-free were compared to those who experienced paresthesia-present therapy at 1, 3, 6, 9, and 12-month follow-ups. Predictor variables for the presence or absence of paresthesias with DRG stimulation were also explored. RESULTS: The percentage of subjects with paresthesia-free pain relief increased from 16.4% at 1-month to 38.3% at 12-months. Paresthesia-free subjects generally had similar or better outcomes for pain severity, pain interference, quality of life, and mood state as subjects with paresthesia-present stimulation. Factors that increased the odds of a subject feeling paresthesia were higher stimulation amplitudes and frequencies, number of implanted leads, and younger age. CONCLUSIONS: Some DRG subjects achieved effective paresthesia-free analgesia in the ACCURATE trial. This supports the observation that paresthesia is not synonymous with pain relief or required for optimal analgesia with DRG stimulation.
Authors: R Norman Harden; Candida S McCabe; Andreas Goebel; Michael Massey; Tolga Suvar; Sharon Grieve; Stephen Bruehl Journal: Pain Med Date: 2022-06-10 Impact factor: 3.637
Authors: Amnon A Berger; Yao Liu; HarLee Possoit; Anna C Rogers; Warner Moore; Kyle Gress; Elyse M Cornett; Alan David Kaye; Farnad Imani; Kambiz Sadegi; Giustino Varrassi; Omar Viswanath; Ivan Urits Journal: Anesth Pain Med Date: 2021-03-28