Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial Article

Full Text via DOI: 10.1016/j.diabres.2023.110865 Web of Science: 001061382800001

Cited authors

  • Petersen EA, Stauss TG, Scowcroft JA, Jaasma MJ, Brooks ES, Edgar DR, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu JJ, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Mehta ND, Sayed D, Lad SP, Dibenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israelc AF, Chang PL, Wu PW, Argoff CE, Nasr CE, Taylor RS, Caraway DL, Mekhail NA

Abstract

  • Aims: To evaluate the long-term efficacy of high-frequency (10 kHz) spinal cord stimulation (SCS) for treating refractory painful diabetic neuropathy (PDN).Methods: The SENZA-PDN study was a prospective, multicenter, randomized controlled trial that compared conventional medical management (CMM) alone with 10 kHz SCS plus CMM (10 kHz SCS+CMM) in 216 patients with refractory PDN. After 6 months, participants with insufficient pain relief could cross over to the other treatment. In total, 142 patients with a 10 kHz SCS system were followed for 24 months, including 84 initial 10 kHz SCS+CMM recipients and 58 crossovers from CMM alone. Assessments included pain intensity, health related quality of life (HRQoL), sleep, and neurological function. Investigators assessed neurological function via sensory, reflex, and motor tests. They identified a clinically meaningful improvement relative to the baseline assessment if there was a significant persistent improvement in neurological function that impacted the participant's well-being and was attributable to a neurological finding.Results: At 24 months, 10 kHz SCS reduced pain by a mean of 79.9% compared to baseline, with 90.1% of participants experiencing >50% pain relief. Participants had significantly improved HRQoL and sleep, and 65.7% demonstrated clinically meaningful neurological improvement. Five (3.2%) SCS systems were explanted due to infection.Conclusions: Over 24 months, 10 kHz SCS provided durable pain relief and significant improvements in HRQoL and sleep. Furthermore, the majority of participants demonstrated neurological improvement. These long-term data support 10 kHz SCS as a safe and highly effective therapy for PDN.Trial Registration: ClincalTrials.gov Identifier, NCT03228420.

Authors

Publication date

  • 2023

Published in

International Standard Serial Number (ISSN)

  • 0168-8227

Number of pages

  • 11

Volume

  • 203