The spinal cord stimulation (SCS) device, which includes 5-6-5 multicolumn surgical leads, delivers mild electrical impulses to the spinal cord to block pain signals from reaching the brain.
The trial will enroll 300 patients and randomize them in 1:1 ratio to receive treatment with either SCS device with optimal medical management (OMM) or OMM alone.
FBSS patients who receive physical rehabilitation and / or oral medications often do not sufficiently improve and need additional interventions, according to the company.
After a six-month observational phase, the study will also compare the proportion of participants in the SCS group who report more than 50% reduction in low back-pain intensity, as measured by the Numeric Pain Rating Scale, with those in the OMM-only group.
The company said the health care utilization data collected from the trials will be used for developing cost analysis models for potential use in future studies evaluating the long-term economic impact of SCS.
Medtronic neuromodulation business pain stimulation and targeted drug delivery general manager and vice president Julie Foster said, "PROMISE provides the opportunity to assess not only the degree of pain relief provided by SCS plus OMM compared to OMM alone in failed back surgery patients, but also to evaluate the economic and quality of life impact of this treatment by looking at such important measures as sleep, ability to work and changes in pain medication."
