On Tuesday, St. Jude Medical announced a clinical study to look at burst stimulation as a potentially more effective –and tingle-free – way to manage chronic pain.
On Wednesday, the Little Canada-based medical technology company said it's launching another study regarding spinal cord stimulation – this one looking at whether combining SCS with peripheral nerve field stimulation (PNfs) offers more effective management of chronic low back and leg pain.
Peripheral nerve field stimulation and spinal cord stimulation involve implanting a stimulation device and small electrical wires, called leads. For spinal cord stimulation, the wires are places along the spine to block pain signals to the brain. For PNfS, wires are placed just under the skin in the subcutaneous tissue to stimulate the network of peripheral nerve fibers in order to reduce the pain at the location where it is most severe. PNfS is not the same as peripheral nerve stimulation (PNS), which targets a specific nerve. Instead, PNfS targets a more general network of nerves.
“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 Dr. Porter McRoberts, an interventional pain physician at Holy Cross Orthopedic Institute in Fort Lauderdale, Fla., 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.”
The SENSE trial is a randomized, prospective, multicenter, clinical study to demonstrate the safety and effectiveness of PNfS used in combination with spinal cord stimulation to manage low back pain and leg pain. The study will also look at whether the treatment is cost-effective. Up to 450 patients will be enrolled at up to 35 sites in the United States.
To qualify for the study, participants must have 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.
“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,” said Dr. Mark D. Carlson, chief medical officer and vice president of global clinical affairs for St. Jude Medical. “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.”