Spinal cord stimulation may be beneficial for painful diabetic neuropathy
medwireNews: Randomized trial findings presented at the virtual 56th EASD Annual Meeting suggest that spinal cord stimulation (SCS) may provide pain relief for people with painful diabetic neuropathy and an inadequate response to conventional treatment.
The SENZA-PDN study included 216 people with chronic, intractable lower limb pain due to diabetic neuropathy who were randomly assigned to receive high-frequency SCS (10 kHz) via an implantable pulse generator (IPG) in addition to standard care, or standard care only. The majority of participants – 93% in the SCS arm and 97% in the control arm – had type 2 diabetes; the mean lower limb pain score on a 10 cm Visual Analog Scale (VAS) at baseline was 7.5 cm for participants given SCS and 7.1 cm for those in the control group.
In the per-protocol analysis, a significantly higher proportion of patients treated with SCS (n=88) versus usual care alone (n=96) achieved the primary endpoint of a 50% or greater reduction in pain VAS score without worsening neurologic deficit from baseline to the 3-month follow-up, at rates of 86% and 5%, respectively.
And the intention-to-treat analysis showed “consistent” results, with a significant difference between the groups, reported Erika Petersen, from the University of Arkansas for Medical Sciences in Little Rock, USA.
Moreover, she said that investigator-assessed sensory improvements were seen in a greater proportion of patients given SCS compared with usual care only (72 vs 7%), and those in the SCS group reported improvements in measures of sleep and quality of life over the study period.
A total of 12.4% of patients given SCS experienced adverse events (AEs), compared with none in the control arm. The most frequently occurring AEs were wound dehiscence, infection, incision or IPG discomfort, and irritation from surgical dressings, each reported in two patients (1.8%). One patient experienced wound dehiscence and infection that was rated as serious and resulted in device explant.
“When we compare this to other studies in non-diabetic spinal cord stimulation […] this rate of infection and wound dehiscence is better than what we see in studies that were done for back and leg pain in non-diabetic patients,” remarked Petersen.
She said that participants will be followed up for 24 months “to look at the maintenance of the improvements in response as well as looking at evaluations of health economics and pain medication usage.”
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