Spinal cord stimulation eases painful diabetic neuropathy

10 kHz spinal cord stimulation (SCS) provided durable pain relief to patients with painful diabetic neuropathy (PDN) in the randomised-controlled SENZA-PDN trial. Treatment effects at 6 months were maintained at 24 months, and the device’s safety was acceptable.

Around a quarter of all patients with diabetes experience PDN. The impact on sleep and overall quality of life is substantial. Current first-line pharmacotherapy and other types of conventional medical management (CMM) are often ineffective.

Dr Erika Petersen (University of Arkansas, AR, USA) explained that SCS reduces pain by electrically stimulating neurons through leads placed in the epidural space. She presented the design and results of the SENZA-PDN study (NCT03228420) [1]. The included 216 participants from 18 USA centres had PDN for over a year, failed on at least 2 pharmacotherapies, and had lower limb pain with an intensity of ≥5 cm on a visual analogue scale (VAS) of 0–10 cm. Participants were randomised 1:1 to 10 kHz SCS plus CMM or CMM only. After 6 months, they were allowed to cross-over.

After 6 months, none of the participants chose to cross over to CMM alone, while 93% of participants in the CMM-only group did. In total (including cross-over), 181 participants received 10 kHz SCS. The trial-to-implant ratio was 85%, meaning 154 participants had permanent implants. Of these, 142 (92%) continued for 24 months of whom Dr Petersen shared the 24-month results. There were no stimulation-related neurological deficits and no explants for loss of efficacy. The infection rate was 5.2% (within the 2.5–10% range reported for SCS across patient populations), and the explant rate was 3.2% (n=5) due to infection. At 6 months, participants receiving 10 kHz SCS had an average pain decrease of 76% and an improvement in motor function and reflexes of 62%. Participants in the control group experienced an average pain increase of 2% and a functional improvement of 3%. Importantly, the pain relief was durable, as participants treated with 10 kHz SCS experienced average pain relief of 80% even at 24 months.

Neurological improvements also endured, with 66% of participants receiving 10 kHz SCS reporting maintained neurological improvements at 24 months. In line with that, a 62% reduction in sleep disturbance at 6 months was observed in the 10 kHz SCS group versus a 4% increase in the control group. At 24 months, this reduction was 66%, with a consistent treatment effect for cross-over subjects.

Discussant Dr Narayan Kissoon (Mayo Clinic, MN, USA) remarked that the sustainability of pain relief might depend on a waveform: the 1-year response for tonic stimulation was 38–56%, but 86% for high-frequency stimulation. Dr Kissoon also explained that after ~2.5 years, SCS is more cost-effective than conservative medical management and that SCS also reduces opioid use. “Any patient who has failed neuropathic pain medications and is a candidate for surgery should be considered for SCS. Almost every treated patient benefits from it, with a number needed to treat of 1.3,” he concluded.

1. Petersen E. 10 kHz SCS Provides Durable Pain Relief and Neurological Improvements for Patients with Painful Diabetic Neuropathy: 24-Month RCT Results. ES1.004, AAN 2023 Annual Meeting, 22–27 April, Boston, USA.

Copyright ©2023 Medicom Medical Publishers



Posted on 26 June 202317 May 2024