By Alex Morrisson
Spinal cord stimulation using a 10 kilohertz device suppresses pain caused by diabetic neuropathy, according to a study presented at the Virtual 2021 Annual Meeting of the American Academy of Neurology (AAN).
In the multicentre randomised SENZA-PDN study, patients diagnosed with diabetic neuropathy said their pain scores decreased from an average of 7.6 cm on a visual analogue scale to 1.7 cm at 6 months, reported Erica Petersen, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas.
In contrast, patients in the trial who were treated with conventional medical management had little benefit at 6 months, said Dr. Petersen. Their baseline pain level on the scale was 7.0 cm, but after 6 months the average pain score was 6.9 cm.
“All patients originally randomised to 10 kilohertz stimulation have completed 12 months of follow up, so we have demonstrated that the relief reported in our study after 6 months in the spinal cord stimulation arm is maintained at 9 months and 12 months,” said Dr. Petersen. “Responder rates remain stable up to 12 months as well. The study will follow all patients out to 24 months to show durability of response.”
Previously, she reported that the trial met its primary endpoint, which was ≥50% pain relief without deterioration of neurological status at 3 months. That metric was met by 5% of the 103 patients who were treated with conventional medical management compared with 86% of the 113 patients who were treated with spinal stimulation (P < .001).
Just 6.3% of conventional medical management subjects were deemed responders and 52% reported worsening pain. In contrast, among patients who received the implant, 85% were considered responders and 2.3% reported worsening pain.
Dr. Petersen said there were 2 infections that required device explant (2.2%).
“This study shows 10 kHz spinal cord stimulation provides profound, sustained pain relief, improves findings on neurological examination as well as patient-reported dysesthesias, and enhances quality of life,” she said. “For painful diabetic neuropathy patients with inadequate response to conservative care, 10 kHz SCS should be recommended as a treatment option.”