Early results of clinical trial show high rate of responders who achieved ≥50 percent pain relief
TUESDAY, Nov. 10, 2020 (HealthDay News) — Low-frequency spinal cord stimulation (SCS) may be effective for treating painful diabetic neuropathy (DN), according to a study scheduled for presentation at the 19th Annual Pain Medicine Meeting, a meeting of the American Society of Regional Anesthesia and Pain Medicine, held virtually from Nov. 20 to 22.
Erika Petersen, M.D., from the University of Arkansas for Medical Sciences in Fayetteville, and colleagues randomly assigned (1:1) 216 patients with painful DN for ≥12 months to 10 kHz SCS (Nevro Corp.) combined with conventional medical management (CMM) or CMM alone (103 patients). This is an interim analysis and follow-up will last for 24 months.
The researchers found no reported study-related adverse events in the control group and 16 study-related adverse events in the SCS+CMM group. There were two procedure-related infections in the 10 kHz SCS+CMM group, yielding a 1.8 percent infection rate. There was a significant difference between the treatment groups with respect to achieving ≥50 percent pain relief and without worsening baseline neurological deficit. At three-month follow-up, there were also differences noted in lower-limb pain scores, responder rates, and investigator-assessed sensory improvements. Similar improvements were seen for the treatment groups across several health-related quality-of-life and functional measures, including the impact of pain on sleep and Global Impression of Change.
“These early results are encouraging for painful DN patients who are refractory to conventional care,” the authors write.
Several authors disclosed financial ties to the medical device industry.
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