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.

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: Erika A Petersen, Thomas G Stauss, James A Scowcroft, Michael J Jaasma, Elizabeth S Brooks, Deborah R Edgar, Judith L White, Shawn M Sills, Kasra Amirdelfan, Maged N Guirguis, Jijun Xu, Cong Yu, Ali Nairizi, Denis G Patterson, Kostandinos C Tsoulfas, Michael J Creamer, Vincent Galan, Richard H Bundschu, Neel D Mehta, Dawood Sayed, Shivanand P Lad, David J DiBenedetto, Khalid A Sethi, Johnathan H Goree, Matthew T Bennett, Nathan J Harrison, Atef F Israel, Paul Chang, Paul W Wu, Charles E Argoff, Christian E Nasr, Rod S Taylor, David L Caraway, Nagy A Mekhail
• Journal: Diabetes research and clinical practice (Diabetes Res Clin Pract) Vol. 203 Pg. 110865 (Sep 2023) ISSN: 1872-8227 [Electronic] Ireland
• PMID: 37536514 (Publication Type: Randomized Controlled Trial, Multicenter Study, Journal Article)
• Copyright: Copyright © 2023. Published by Elsevier B.V.

Topics

• Humans
• Spinal Cord Stimulation (methods)
• Diabetic Neuropathies (therapy)
• Quality of Life
• Prospective Studies
• Pain
• Treatment Outcome
• Diabetes Mellitus