Mayo Clinic Proceedings: Innovations, Quality & Outcomes (Aug 2022)

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

  • 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,
  • Nagy A. Mekhail, MD, PhD

Journal volume & issue
Vol. 6, no. 4
pp. 347 – 360

Abstract

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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