St Jude Medical has announced it has launched a clinical study to evaluate the combination of peripheral nerve field stimulation and spinal cord stimulation to determine whether the two therapies together offer more effective management of chronic low back and leg pain than spinal cord stimulation alone. The first patient in the SENSE (subcutaneous and epidural neuromodulation system evaluation study) trial was enrolled by Thomas Yearwood, an interventional pain physician at Comprehensive Pain & Rehabilitation in Pascagoula, USA.
According to a St Jude Medical press release, the SENSE trial is a randomised, prospective, multicentre clinical study that will collect information regarding pain reduction, quality of life and changes in disability measures. Additionally, the study will gather cost-effectiveness data to support reimbursement coverage for peripheral nerve field stimulation used in conjunction with spinal cord stimulation. A maximum of 450 patients at up to 35 sites in the USA will be enrolled. To qualify for the study, participants must have chronic low back and leg pain as a result of failed back surgery syndrome. Study participants will be randomly assigned to either a spinal cord stimulation -only group or a group that includes peripheral nerve field stimulation combined with spinal cord stimulation.
The study design uses 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 spinal cord stimulation leads.
“We often see patients who have had multiple back surgeries to alleviate their debilitating chronic pain. Ultimately, many of these surgeries fail, leaving patients to seek other options like neurostimulation therapy,” said Porter McRoberts, interventional pain physician, Holy Cross Orthopedic Institute, Fort Lauderdale, USA, and the principal investigator in the study. “Peripheral nerve field stimulation therapy, targeting local nerves near the painful area, combined with traditional spinal cord stimulation, targeting the central nervous system, has the potential to improve our ability to effectively manage patients with difficult-to-treat low back pain.”