1. High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial
- Author
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Erika A. Petersen, MD, Thomas G. Stauss, MD, James A. Scowcroft, MD, Elizabeth S. Brooks, PhD, Judith L. White, MD, Shawn M. Sills, MD, Kasra Amirdelfan, MD, Maged N. Guirguis, MD, Jijun Xu, MD, PhD, Cong Yu, MD, Ali Nairizi, MD, Denis G. Patterson, DO, Kostandinos C. Tsoulfas, MD, Michael J. Creamer, DO, Vincent Galan, MD, Richard H. Bundschu, MD, Neel D. Mehta, MD, Dawood Sayed, MD, Shivanand P. Lad, MD, PhD, David J. DiBenedetto, MD, Khalid A. Sethi, MD, Johnathan H. Goree, MD, Matthew T. Bennett, MD, Nathan J. Harrison, MD, Atef F. Israel, MD, Paul Chang, MD, Paul W. Wu, MD, Charles E. Argoff, MD, Christian E. Nasr, MD, Rod S. Taylor, PhD, David L. Caraway, MD, PhD, and Nagy A. Mekhail, MD, PhD
- Subjects
Medicine (General) ,R5-920 - Abstract
Objective: To evaluate high-frequency (10-kHz) spinal cord stimulation (SCS) treatment in refractory painful diabetic neuropathy. Patients and Methods: A prospective, multicenter randomized controlled trial was conducted between Aug 28, 2017 and March 16, 2021, comparing conventional medical management (CMM) with 10-kHz SCS+CMM. The participants had hemoglobin A1c level of less than or equal to 10% and pain greater than or equal to 5 of 10 cm on visual analog scale, with painful diabetic neuropathy symptoms 12 months or more refractory to gabapentinoids and at least 1 other analgesic class. Assessments included measures of pain, neurologic function, and health-related quality of life (HRQoL) over 12 months with optional crossover at 6 months. Results: The participants were randomized 1:1 to CMM (n=103) or 10-kHz SCS+CMM (n=113). At 6 months, 77 of 95 (81%) CMM group participants opted for crossover, whereas none of the 10-kHz SCS group participants did so. At 12 months, the mean pain relief from baseline among participants implanted with 10-kHz SCS was 74.3% (95% CI, 70.1-78.5), and 121 of 142 (85%) participants were treatment responders (≥50% pain relief). Treatment with 10-kHz SCS improved HRQoL, including a mean improvement in the EuroQol 5-dimensional questionnaire index score of 0.136 (95% CI, 0.104-0.169). The participants also reported significantly less pain interference with sleep, mood, and daily activities. At 12 months, 131 of 142 (92%) participants were “satisfied” or “very satisfied” with the 10-kHz SCS treatment. Conclusion: The 10-kHz SCS treatment resulted in substantial pain relief and improvement in overall HRQoL 2.5- to 4.5-fold higher than the minimal clinically important difference. The outcomes were durable over 12 months and support 10-kHz SCS treatment in patients with refractory painful diabetic neuropathy. Trial registration: clincaltrials.gov Identifier: NCT03228420
- Published
- 2022
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