"I would recommend 10 kHz SCS for patients who continue to have significant pain despite the best available medical treatments," Dr. Erika Petersen of the University of Arkansas Medical Sciences, in Little Rock, who worked on the study, told Reuters Health by email.
The findings are from the first three months of a two-year study. They were presented September 11 at the PAINWeek 2020 virtual conference.
Dr. Petersen and her colleagues compared 103 patients randomized to conventional pain management with 113 who also received a spinal cord stimulator implant from Nevro Corp.
At three months, 79% of those who underwent spinal stimulation met the primary endpoint of 50% or greater pain relief without exacerbating neurological deficits. By comparison, only 5% of the control group met the endpoint (P<0.001), according to an intention-to-treat analysis.
On a 0-10 cm visual analog scale, patients in the stimulation group went from 7.6 cm at the outset of the study to 1.7 cm at three months. The control group reported a drop from 7 cm to 6.5 cm.
Per-protocol analysis showed that 89% of the study group experienced 50% or more pain relief compared to 7% of the control group. The spinal stimulation group experienced quality-of-life, functional and sensory improvements in roughly similar proportions.
At three months, the study group had 16 procedure-related adverse events and two infections, for an infection rate of 1.8%.
Roughly 20% of diabetics develop painful diabetic neuropathy, and it is often resistant to drugs, the researchers note in the conference abstract.
All the patients in their study had experienced symptoms for a year or longer before enrollment. They had tried at least two classes of analgesics, including antiepileptics and selective serotonin-norepinephrine-reuptake inhibitors or tricyclic antidepressants prescribed for neuropathic pain. Many patients had also been prescribed opioids in spite of a lack of evidence for their benefit, Dr. Petersen said.
Diabetic neuropathy can also resist treatment with low-frequency spinal cord stimulation, which is the conventional treatment in the range of 40-60 Hz.
One explanation that increasing the frequency may be effective could be that stimulation above 5 kHz has a different mechanism of action than lower frequencies, Dr. Petersen said. High frequencies may affect different cell types in the spinal cord.
The results so far are promising, according to Dr. Prempreet Bajaj, an orthopedic surgeon at Loyola University Medical Center in Maywood, Illinois. Dr. Bajaj studies spinal cord stimulation to treat chronic knee pain, but was not involved in the new study.
The authors compared high-frequency SCS "to conventional management and it wasn't just a slight improvement," he told Reuters Health by phone. "They blew it away. It was a pretty significant difference. The data kind of tells you and speaks for itself, that there's a role here."
These short-term data show that the procedure can be safe for patients with diabetes, Dr. Petersen said. "Longer-term data will aid adoption of this therapy by the medical community and insurance companies," she added.
By Rob Goodier
SOURCE: https://bit.ly/3mZrkyc PAINWeek, presented September 11, 2020.
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