A southern California company has begun a study to evaluate the safety and effectiveness of the “StimRouter” neuromodulation system for sufferers of chronic peripheral nerve pain. Bioness will enroll 126 patients in up to 10 sites in the U.S. for the study, which will take over two years to complete.
“The StimRouter could potentially provide – for the first time – a non-pharmaceutical treatment option that can be targeted directly to the pain site for more focused pain relief. The results of this study could have a significant impact on the way we treat patients with peripheral nerve pain,” said Timothy Deer, MD, a pain management specialist at The Center for Pain Relief at Saint Francis Hospital in Charleston, West Virginia.
20 million Americans suffer from chronic peripheral nerve pain. The disorder triggers painful burning and tingling sensations, or feeling like “pins and needles.” Current treatments include spinal cord stimulation and pain medication. Because of rising abuse, addiction and deaths from painkillers, many patients and health care providers are looking for alternate ways to relieve pain.
Unlike other neurostimulators, the StimRouter is designed to be used at the pain site rather than the spinal cord. It delivers low-level electrical impulses directly to the nerve that carries the pain signal to the brain. The device also has the capability of storing stimulation programs to provide patients with a variety of treatment options depending on their activity or level of pain.
The study will evaluate the effect of the system on patients’ overall pain, as well as changes in pain medication, quality of life, changes in pain level, patient satisfaction and long-term safety.