LITTLE ROCK -- People with chronic painful diabetic neuropathy are being enrolled in a University of Arkansas for Medical Sciences (UAMS) research study of a spinal cord stimulation device designed to reduce the pain.
Led at UAMS by Erika Petersen, M.D., a neurosurgeon and researcher, the study is part of a clinical trial being conducted at sites across the United States.
Implanted spinal cord stimulation devices have been shown to relieve chronic pain, but this study is the first to test a device's effectiveness when used specifically for continuous diabetic neuropathy pain in the legs and feet said Petersen, director of Functional and Restorative Neurosurgery and associate professor in the UAMS College of Medicine.
About a quarter of Americans with diabetes have painful diabetic neuropathy, according to the national Centers for Disease Control and Prevention. In Arkansas, where an estimated 363,000 people have type 2 diabetes, about 73,000 of those residents (20 percent) would be expected to have painful diabetic peripheral neuropathy. The number could be higher -- a National Institutes of Health-funded study in five rural Arkansas counties concluded that diabetic peripheral neuropathy was alarmingly underdiagnosed.
Diabetic peripheral neuropathy is a debilitating, painful disease for which there are few effective treatments said Johnathan Goree, M.D., a sub-investigator on the study and director of the Chronic Pain Division of the Department of Anesthesiology in the UAMS College of Medicine.
If this spinal cord stimulation system proves to be effective, it could provide excellent pain control without many of the side effects of opioid medications.
The device, Senza® Spinal Cord Stimulation system, was developed by Nevro, a medical device company based in Redwood, Calif. It works by sending electrical pulses to interrupt pain signals and provide pain relief.
The system's implantable pulse generator is placed under the skin of the abdomen or buttocks along with the leads - thin wires that deliver the electrical pulses from the pulse generator to the spinal cord.
Study participants will be randomly placed in one of two groups: One providing conventional medical treatments, such as medications and physical therapy; and the other using the spinal cord stimulation device.
Eligibility requirements for participating in the study include:
A diagnosis of painful diabetic neuropathy of the feet and/or legs
Having tried standard treatments
Be 22 years of age or older
Those interested in learning if they are eligible may contact the UAMS Translational Research Institute study coordinator, 501-398-8622.