An implantable spinal cord stimulation treatment using high-frequency sound was effective at relieving pain from diabetic neuropathy and also led to improvements in quality of life over a yearlong period, according to study results presented virtually at the 81st Scientific Sessions of the American Diabetes Association (ADA) and reported in an article at Medscape.
The study included participants who weren’t able to achieve adequate neuropathy pain control using conventional treatments and management techniques. Interim results after six months of treatment were previously published in the journal JAMA Neurology, and the new results show that the treatment remained effective after another six months. A total of 216 participants were randomly assigned either to receive the spinal cord stimulation treatment (113 participants), or to continue using conventional management techniques alone (103 participants). The two groups were broadly similar, with most participants having type 2 diabetes for greater than 12 years, and symptoms of peripheral neuropathy for greater than seven years. At the time of enrollment in the study, all participants had lower-limb pain with an intensity of at least 5 centimeters based on the visual analog scale (VAS).
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Spinal cord stimulation associated with reductions in pain score
In the previously published results, after six months, 79% of participants who received the spinal cord stimulation treatment experienced at least a 50% reduction in their pain score, compared with just 5% of the conventional treatment group. In the latest results, covering months seven to 12, 86% of participants who received the spinal cord treatment achieved this level of pain reduction. This doesn’t necessarily mean that the spinal treatment became more effective over time, because the study used a cross-over design in which people in either group could switch to the other group after six months if they wanted to. None of the participants who originally received the spinal treatment chose to switch to conventional treatment after six months, while 82% of the conventional treatment group decided to switch to receiving the spinal cord stimulation treatment during the second six-month period.
Participants who received the spinal stimulation treatment also reported improvements in neurological function, including motor, sensory, and reflex function. The researchers noted that these improvements were somewhat unexpected, and represent the first time such neurological improvements have been seen in a randomized trial of spinal cord stimulation. The most common side effect of the treatment was infection, which affected eight people, or about 5% of those who received it. Three people were able to see the infection resolved using conservative treatments, while five needed to have the implantable treatment device removed.
These results show that for people with diabetic neuropathy who are otherwise unable to achieve adequate pain relief, spinal cord stimulation may be a useful treatment option. The current study will continue for another 12 months, showing whether this treatment remains effective after a total of 24 months.