Boston Scientific today announced the start of patient enrollment in the EVIDENCE Clinical Trial, which compares the therapeutic and cost effectiveness of spinal cord stimulation (SCS) therapy to spine re-operation in patients with failed back surgery syndrome (FBSS).
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. The trial will examine treatment response rates (leg pain relief with no request for the alternative therapy) at six and 24 months. 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,” said Richard B. North, M.D., neurosurgeon at The Sandra and Malcolm Berman Brain and Spine Institute in Baltimore, and Principal Investigator of the trial. “Ultimately, this study may provide support to shift SCS earlier in the treatment paradigm for patients who suffer chronic pain resulting from FBSS,” said Dr. Kumar. “EVIDENCE may also demonstrate the cost effectiveness of SCS compared to re-operation.”
The Precision Plus Spinal Cord Stimulator System delivers electrical signals that travel along nerve fibers through the spinal cord to the brain. The system masks pain signals by delivering doses of electricity to change pain signals into signals that the brain interprets as a pleasant sensation called paresthesia. Spinal cord stimulation is prescribed for patients with chronic pain in the trunk and/or limbs who have not received adequate relief from physical therapy, pain medications, prior surgeries or other methods.
FBSS is defined as persistent or recurrent pain following one or more lumbosacral spine surgical procedures. The pain associated with FBSS is commonly neuropathic and is often described by patients as shooting or burning. SCS is particularly effective in treating neuropathic pain.