Spinal cord stimulators provide relief from diabetic neuropathic pain

An implanted 10 kHz spinal cord stimulator, when used in tandem with opioids and other pain relievers, provided patients relief from diabetic neuropathic pain, data show.

Results from the multicenter, randomized controlled trial were presented during the American Society of Regional Anesthesia and Pain Medicine’s Annual Pain Medicine Meeting, which was held virtually.

“Some people may be familiar with ultrasonic jewelry cleaners. These typically use ultrasound waves between 15 kHz to 40 kHz to agitate the water in the jewelry tank,” Erika A. Petersen, MD, FAANS, FACS, a professor of neurosurgery at the University of Arkansas for Medical Sciences, told Healio Primary Care. “In the same way ultrasonic cleaning is thought to be more effective than just a regular wash, we have seen that faster frequency neurostimulation has provided a superior outcome compared with lower frequencies in the treatment of chronic pain conditions such as painful diabetic neuropathy.”

Petersen and colleagues assigned 216 “well-matched” patients with diabetic neuropathic pain in an approximate 1:1 ratio to receive either a combination of 10 kHz SCS (Nevro) and conventional medical management or CMM only.

According to Petersen, CMM consisted of “gabapentin, pregabalin, duloxetine and even opioids to represent the very real-world experience of millions of patients for whom the currently available treatments do not work.”

All trial participants had diabetic neuropathic pain for 12 months or longer and an average lower limb pain intensity of 5 cm or greater. Trial participants could not have an HbA1c level of 10% or higher, upper limb pain intensity of 3 cm or greater or take opioids of 120 mg morphine equivalents or more daily.

After 3 months of treatment, the patients who received the 10 kHz SCS and CMM reported pain relief of 50% or greater and no worsening of their baseline neurological deficit than those who only received CMM (P < .001), according to the researchers. Petersen and colleagues also reported positive differences in investigator-assessed sensory improvements, lower limb pain scores and responder rates. They found similar differences between treatment groups regarding the impact of diabetic neuropathic pain on sleep and their Global Impression of Change scores — a measure of a patient's belief about the efficacy of treatment. There were 16 study-related adverse events and two procedure-related infections among patients who received the 10 kHz spinal cord stimulation and CMM and no study-related adverse events among patients who received only CMM.

Petersen said 10 kHZ SCS is “non-pharmacological, minimally invasive, safe and reversible” and has been used to treat 55,000 patients worldwide for several other chronic pain conditions.

The patients in the current study will be followed for a total of 24 months, according to the researchers.

“While it is too soon to draw conclusions about health care costs and long-term utility from this study, it is very reasonable to expect that effective pain control will no doubt reduce the health care burden for patients with painful diabetic neuropathy,” Petersen said.