Spinal cord stimulation provides durable pain relief for diabetic neuropathy with an acceptable safety profile and sustained results through 24 months.
About a quarter of all patients with diabetes experience diabetic neuropathy (DN), and the impact on sleep and overall QOL is substantial. Current first-line pharmacotherapy and other types of conventional medical management (CMM) are ineffective in many cases.
Erika Petersen, MD, explained that spinal cord stimulation (SCS) reduces pain by electrically stimulating neurons through leads placed in the epidural space. She noted that as a result of her group’s previous work, SCS is approved by the FDA for the treatment of DN and has been recommended by the American Association of Clinical Endocrinology (AACE) and the American Diabetes Association (ADA).
Dr. Petersen presented the design and results of the Senza-DN study. A total of 216 patients were recruited from 18 centers across the United States. Participants had DN for more than a year, failed on at least two pharmacotherapies, and had lower limb pain with an intensity of 5 cm or greater on a visual analogue scale (VAS) of 0-10 cm. The 216 participants were randomized 1:1 to 10 kHz SCS plus CMM or CMM alone. After 6 months, participants were allowed to cross over if desired. Dr. Petersen reported outcomes through 24-month follow-up.
The number of participants who were originally assigned or crossed over to 10 kHz SCS totalled 181. The trial-to-implant ratio was 85%, meaning 154 patients received an implant. Of these, 142 (92%) continued for 24 months. There were no stimulation-related neurological deficits and no explants for loss of efficacy, as well as an infection rate of 5.2% (which is within the range of 2.5% to 10% reported for SCS across patient populations), and a 3.2% explant rate (N=5) due to infection.
At 6 months, patients receiving 10 kHz SCS had an average pain decrease of 76% and an improvement in motor function and reflexes of 62%. Patients in the control group experienced an average pain increase of 2% and a functional improvement of 3%. Pain relief was found to be durable.
At 24 months, patients treated with 10 kHz SCS experienced average pain relief of 80%.
Neurological improvements were also durable, with 66% of patients receiving 10 kHz SCS reporting them at 24 months. Importantly, there was a 62% reduction in sleep disturbance at 6 months in the 10 kHz SCS group, compared to a 4% increase in the control group. At 24 months, this reduction was 66%, with a consistent treatment effect for crossover subjects.
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