Pain relief from spinal cord stimulation in diabetic neuropathy sustained at 18 months
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SAN DIEGO — Spinal cord stimulation reduces pain and improves quality of life for at least 18 months for most adults with painful diabetic neuropathy, according to a speaker here.
As Healio previously reported, adults with painful diabetic neuropathy receiving an implanted 10 kHz spinal cord stimulator in a randomized controlled trial had reduced levels of pain and improved quality of life at 12 months. In new data from the trial presented at the AACE Annual Scientific and Clinical Conference, the improvements in pain relief and quality of life were maintained during a follow-up at 18 months.
“We are so limited in the FDA and non-FDA approved therapies for painful diabetic neuropathy,” Christian Nasr, MD, chief for the division of endocrinology, internal medicine at the University of Arizona College of Medicine in Phoenix, told Healio. “Patients can feel helpless when they can’t do anything about the pain. This is just another method that goes beyond the pharmacological approach.”
Nasr presented findings from the 18-month follow-up of a randomized controlled trial where 216 adults at 18 centers in the U.S. with painful diabetic neuropathy who were refractory to conservative treatments were randomly assigned to receive 10 kHz spinal cord stimulation followed by conventional medical management (n = 113), or conventional medical management alone (n = 103). Participants receiving conventional medical management alone were given the option to cross over to spinal cord stimulation treatment at 6 months. Pain severity was measured using a 10 cm visual analog scale. Quality of life improvements were self-reported.
The treatment group had an improvement in lower limb pain from 7.6 cm at baseline to 1.7 cm at 6 months and 1.6 cm at 12 months. The pain relief was sustained at 1.7 cm at 18 months. Those in the conventional management group who crossed over to spinal cord stimulation at 6 months had lower limb pain on the visual analog scale improve from 7.5 cm at crossover to 1.9 cm at 12 months and 2.2 cm at 18 months. Of those who completed the 18-month follow-up, 85% were deemed responders at 18 months, and 54% were deemed profound responders with pain relief of 80% or greater.
Improvements in pain interference with mood and daily activities at 12 months were also sustained at 18 months in the study cohort. About 70% of participants in the treatment group reported clinically significant improvements in sleep at 18 months.
Nasr said future studies should be conducted to see if the pain relief benefits of spinal cord stimulation persist beyond 18 months and whether the procedure will be cost-effective in practice.
“We’re excited to see if this is going to be a viable approach,” Nasr said. “It is an intervention and it’s not like taking a pill, it’s an invasive procedure. We have to look at this very carefully.”
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Nasr C, et al. Durability of 10-kHz spinal cord stimulation for painful diabetic neuropathy: 18-month multicenter randomized controlled trial results. Presented at: American Association of Clinical Endocrinology Annual Scientific and Clinical Conference; May 12-14, 2022; San Diego.
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