The study involved 216 people who had painful diabetic neuropathy symptoms for at least a year and did not respond to medication. Half of the people received spinal cord stimulation and regular medical treatment for six months.
Half received only regular medical treatment. After six months, people had the option to switch to another treatment. People were followed for only two years.
Spinal cord stimulation involves a device implanted under the skin. The device provides electrical stimulation to the spinal cord to interrupt pain signals to the brain.
After six months, people who received stimulation reported a 76% reduction in average pain, while those who did not received stimulation reported a 2% increase in average pain. In tests of their motor function, sensation and reflexes, improvement was observed in 62% of those receiving stimulation and only 3% of those receiving medication.
A total of 93% of drug-only and switch-eligible subjects chose to receive stimulation after six months, while none of those receiving stimulation chose to receive drug-only.
Some hope for people with diabetic neuropathy
After two years, people reported an 80% improvement in average pain, and 66% continued to improve motor function, sensation and reflexes. None of the participants removed their device because it was ineffective.
Eight people had device-related infections. Three of them were cleared and five, or 3%, had their devices removed because of infection, Petersen said, which is in the range reported for people receiving spinal cord stimulation for other conditions.
High frequency stimulation provides more pain relief than low frequency stimulation. High frequency stimulation also does not produce the “pins and needles” sensation that comes with low frequency stimulation.
This study shows that high-frequency stimulation provides long-term pain relief with acceptable safety. Improvements in motor function, sensation, and reflexes suggest that this therapy may have disease-modifying potential.
Confirmation of the results through studies in larger human groups may further our understanding of this spinal cord stimulation therapy for the treatment of painful diabetic neuropathy.