Back in February, the FDA approved two more neurostimulators to treat chronic pain caused by peripheral neuropathy related to blood sugar concerns. This was heralded as wonderful news as 30 percent of people with blood sugar concerns experience peripheral neuropathy. The condition can negatively impact people’s quality of life, sleep, mood and social lives.
The devices claim to use spinal cord stimulation to help people feel significantly less pain than traditional treatments. However, not all experts believe that there is strong evidence that spinal cord stimulation works.
A new study published this month in Mayo Clinic Proceedings seemed to back up the claims of the devices. The paper was looking at an older device that’s the same but from a different manufacturer. Twelve months after having the Senza Spinal Cord Stimulation (SCS) system implanted in their bodies, people seemed to be having positive results. Eighty-five percent of the patients had 50 percent and had measurably improved quality of life and were highly satisfied. While an implanted device may seem extreme, it’s no different than having a pacemaker or pump — implanted medical devices are becoming more commonplace all the time.
“Results show that 10 kHz SCS provides large, clinically meaningful reductions in pain as well as large improvements in sleep and quality of life,” said the lead author, Dr. Erika Petersen, professor of neurosurgery at the Univ. of Arkansas for Medical Sciences. “Clinically, the implications are substantial as doctors now have a new treatment option to offer their patients, and one that can provide real benefits to patients’ lives.”
However, others question the methodologies of the positive studies around the devices. They also question the quality of the results and possible conflicts of interest of the authors. They believe that too many people from the original group were left out of the final study results as being outliers. They also worry about the placebo effect.
“An open-label study with a pain outcome is highly susceptible to placebo effects, especially when studying a device,” said Dr. Brian Callaghan, associate professor of neurology at Michigan Medicine and expert on peripheral neuropathy pain, “so this is really quite limited evidence.”
There was no placebo group in the study. People received the device or standard treatment, not a fake treatment to see how people would react with the power of suggestion. “What would spark real interest in me is a more definitive trial that had a true sham procedure so we can see if this really works,” he said.
People in the study supposedly were physically healthier, not simply experiencing less pain. That struck him as off as well. “This doesn’t make a lot of sense and is hard to believe,” said Dr. Callaghan. “Improvements are quite unexpected given no data indicating that the device can improve the underlying disease.”
Dr. Gary Franklin, a research professor of neurology and expert on peripheral neuropathy, stopped just short of calling the research baloney. He believed the results were simply too good to be true. “I don’t know how you get a miraculous result like that, nothing works that well.”
We aren’t writing the paper off as fake. These products have been on the market for some time, and people are seeing results. But we do think it’s good to question products that promise miracle results. While implanted devices are becoming more common, it can still be a big commitment in money and a significant medical procedure. If you suffer from peripheral neuropathy pain, you may wish to discuss the devices with your doctor. However, traditional treatments are proven to offer relief, and this may be a fad that doesn’t pan out.