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.
Diabetes research and clinical practice
Diabetes mellitus; Neuropathy; Painful diabetic neuropathy; Sensory function; Spinal cord stimulation; washington; swedish
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.
Neurosciences (Brain & Spine)
Kidney & Diabetes
Petersen, Erika A; Stauss, Thomas G; Scowcroft, James A; Jaasma, Michael J; Brooks, Elizabeth S; Edgar, Deborah R; White, Judith L; Sills, Shawn M; Amirdelfan, Kasra; Guirguis, Maged N; Xu, Jijun; Yu, Cong; Nairizi, Ali; Patterson, Denis G; Tsoulfas, Kostandinos C; Creamer, Michael J; Galan, Vincent; Bundschu, Richard H; Mehta, Neel D; Sayed, Dawood; Lad, Shivanand P; DiBenedetto, David J; Sethi, Khalid A; Goree, Johnathan H; Bennett, Matthew T; Harrison, Nathan J; Israel, Atef F; Chang, Paul; Wu, Paul W; Argoff, Charles E; Nasr, Christian E; Taylor, Rod S; Caraway, David L; and Mekhail, Nagy A, "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." (2023). Articles, Abstracts, and Reports. 7784.