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

Petersen, E. A. et al. (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. Mayo Clinic Proceedings, 6(4), pp. 347-360. (doi: 10.1016/j.mayocpiqo.2022.05.003)

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

• Item Type: Articles
• Additional Information: Grant Support: The work was supported by Nevro Corp.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Taylor, Professor Rod
• Authors: Petersen, E. A., Stauss, T. G., Scowcroft, J. A., Brooks, E. S., White, J. L., Sills, S. M., Amirdelfan, K., Guirguis, M. N., Xu, J., Yu, C., Nairizi, A., Patterson, D. G., Tsoulfas, K. C., Creamer, M. J., Galan, V., Bundschu, R. H., Mehta, N. D., Sayed, D., Lad, S. P., DiBenedetto, D. J., Sethi, K. A., Goree, J. H., Bennett, M. T., Harrison, N. J., Israel, A. F., Chang, P., Wu, P. W., Argoff, C. E., Nasr, C. E., Taylor, R. S., Caraway, D. L., and Mekhail, N. A.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > MRC/CSO SPHSU
• Journal Name: Mayo Clinic Proceedings
• Publisher: Elsevier Inc on behalf of Mayo Foundation for Medical Education and Research
• ISSN: 0025-6196
• ISSN (Online): 1942-5546
• Published Online: 01 July 2022
• Copyright Holders: Copyright © 2022 The Authors
• First Published: First published in Mayo Clinic Proceedings 6(4):347-360
• Publisher Policy: Reproduced under a Creative Commons licence