St. Jude Medical, a global medical device company, has initiated a US clinical study to evaluate the combination of peripheral nerve field stimulation (PNfS) and spinal cord stimulation (SCS) in the management of chronic low back and leg pain.
The SENSE subcutaneous and epidural neuromodulation system evaluation study has been designed to evaluate the safety and efficacy of PNfS used in combination with SCS to manage patients with chronic low back pain and leg pain when compared to SCS therapy alone.
The SENSE study will gather information regarding pain reduction, quality of life and changes in disability measures.
In addition to information collection, the study will also gather cost-effectiveness data to support reimbursement coverage for PNfS used in conjunction with SCS.
The randomized, multicenter clinical study will enroll up to 450 patients at approximately 35 investigative sites in the US. The study will enroll patients with chronic low back and leg pain as a result of failed back surgery syndrome, a condition that refers to patients with back pain or leg pain despite lumbar surgery.
Study participants will be randomly assigned to either an SCS-only group or a group that includes PNfS combined with SCS.
St. Jude Medical chief medical officer and global clinical affairs vice president Dr Mark D Carlson noted traditional spinal cord stimulation therapy has been used to manage chronic pain for more than 40 years and it works very well for many pain conditions.
"Peripheral nerve field stimulation as an adjunct therapy has the potential to improve outcomes for those who struggle with severe chronic low back and leg pain," Dr Carlson added.
The study design uses the US Food and Drug Administration (FDA) approved Eon Mini and Eon rechargeable neurostimulators with percutaneous leads. Study physicians may also opt to use the Epiducer lead delivery system to aid in the placement of SCS leads.
This system allows physicians to place multiple neurostimulation leads in the epidural space through a single entry point.