High-frequency spinal cord stimulation provides pain relief for diabetic neuropathy
An implanted 10 kHz spinal cord stimulator combined with conventional care provides better pain relief and neurologic improvement for people with painful diabetic neuropathy compared with conventional care alone, according to a speaker.
“Painful diabetic neuropathy is a common occurrence for patients with diabetes and can have a tremendous negative impact on their quality of life,” Erika A. Petersen, MD, professor of neurosurgery at the University of Arkansas for Medical Sciences in Little Rock, told Healio. “Currently, the best available treatments include several types of medications and topical solutions, but there are many patients who do not achieve adequate pain relief or cannot tolerate side effects from these treatments. We need new options for patients who have tried the recommended first- and second-line treatments but still suffer with severe pain.”
Researchers conducted a prospective randomized controlled trial with 216 adults who had painful diabetic neuropathy for at least 12 months at 18 centers in the U.S. Those who were not helped with medications, had lower-limb pain intensity of 5 cm or higher and upper-limb pain intensity of less than 3 cm on the 10 cm visual analog scale, and had an HbA1c of 10% or lower were included. Participants were randomly assigned to receive 10 kHz spinal cord stimulation (Nevro) in addition to continued conventional medical management (n = 113) or conventional medical management alone without spinal cord stimulation (n = 103). All participants had the option to crossover to the other treatment group at 6 months if they had insufficient pain relief and were dissatisfied with treatment and if the change was deemed appropriate by their physician. Visual analog scale was used to measure pain at baseline and 6 months. Participants also completed a standardized neurologic examination and questionnaires to measure quality of life at baseline and 6 months.
The data were presented at the American Association of Clinical Endocrinology virtual meeting.
More pain relief with spinal cord stimulation
Participants receiving conventional medical management alone had no change to their pain over 6 months, with 51.6% reporting a worsening of pain and only 5.4% deemed responders with a 50% or better improvement in pain relief. Those receiving spinal cord stimulation reported a 76.3% decrease in pain at 6 months, with 85.1% deemed responders (P < .001 compared with control group) and only 2.3% reporting worse pain. Mean HbA1c and BMI did not change at 6 months in either group. At 6 months, 81.7% in the medical management group elected to crossover to the spinal cord stimulation group, whereas no participants in the spinal cord stimulation group elected to crossover (P < .001).
Fewer sleep disturbances, neurologic improvements
Sleep disturbances due to pain improved by an average of 61.9% in the spinal cord stimulation group, whereas no change was reported by medical management participants. On the neurologic examination, 61.9% of those in the spinal cord stimulation group had improvements at 6 months compared with baseline vs. 3.3% in the medical management group (P < .001).
“A majority of patients treated with 10 kHz spinal cord stimulation in the study were observed to have improvements in neurological function, including better sensation in their feet,” Petersen said. “This finding could be of great benefit to patients who are at risk of injury due to numbness in their feet. We need to see if this improvement persists over the full 2-year study follow-up.”
In the spinal cord stimulation group, three study-related adverse events were reported for infections, including two cases of stimulator removal (2.2%). No stimulation-related neurologic defects were reported.
“I’m hopeful that physicians involved in the care of patients with painful diabetic neuropathy will consider high-frequency spinal cord stimulation as a treatment option for their patients with refractory symptoms,” Petersen said. “Our study has shown this therapy to be safe and highly effective for pain control. This is a large patient population with significant unmet needs.”
Reference:
Petersen EA, et al. JAMA Neurol. 2021;doi:10.1001/jamaneurol.2021.0538.
Collapse
Petersen E. Neuromodulation for treatment of painful diabetic neuropathy: Sustained benefits of 10 kHz spinal cord stimulation in a randomized controlled trial. Presented at: American Association of Clinical Endocrinology Annual Meeting; May 26-29, 2021 (virtual meeting).