EVIDENCE is a randomized, controlled trial enrolling 132 patients at 20 sites worldwide. Patients in the SCS arm of the trial will receive the Boston Scientific Precision Plus Spinal Cord Stimulator System, which delivers electrical signals that travel along nerve fibers through the spinal cord to the brain, masking pain signals.
The trial will examine treatment response rates (leg pain relief with no request for the alternative therapy) at six and 24 months, according to the release. Successful patient response is defined as having greater than or equal to 50 percent relief of pain in the lower extremities compared to pain levels prior to the intervention.
“The standard approach to patients who continue to have persistent back and leg pain after lumbosacral spine surgery has been to look for another surgical treatment,” Richard B. North, MD, neurosurgeon at The Sandra and Malcolm Berman Brain and Spine Institute in Baltimore and principal investigator of the trial, said in the release. “Following the positive, single-center trial we conducted at Johns Hopkins, the EVIDENCE multi-center trial will provide important data on the comparative effectiveness of SCS versus surgical spine reoperation in the management of chronic pain in FBSS patients.”
Read the release on Boston Scientific’s EVIDENCE trial.
