US-based medical technology company Medtronic has initiated a prospective, open-label, parallel-group clinical study of its neurostimulation therapy device for treating patients with chronic low back pain associated with failed back surgery syndrome (FBSS).
Featuring the company's multicolumn surgical leads, Specify 5-6-5, the spinal cord stimulation (SCS) device delivers mild electrical impulses to the spinal cord to block pain signals from reaching the brain.
The trial, PROMISE, will enrol 300 patients from 30 centres in the US, Canada and Europe and randomise them in a 1:1 ratio to receive treatment with either the SCS device with optimal medical management (OMM) or OMM alone.
The study will evaluate the effectiveness of the device in treating debilitating chronic low back pain, which affects 10% of the US population.
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.
Medtronic said the health care utilisation data collected from the trials will be used to develop 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."
Image: Medtronic corporate headquarters in Fridley, Minnesota, US. Photo: Courtesy of Bobak Ha'Eri.