St Jude Medical’s Burst stimulation can relieve chronic pain more effectively than traditional tonic spinal cord stimulation (SCS), according to the SUNBURST study. The study showed that patients generally preferred Burst stimulation to traditional SCS. Most patients also experienced a reduction in paraesthesia, experienced no paraesthesia at all.
The results of the prospective, randomised study—which is intended to support US FDA approval of Burst stimulation therapy—were presented at the 19th annual meeting of the North American Neuromodulation Society (NANS) in Las Vegas, USA.
“We are excited to report the positive results of the SUNBURST study, which shows Burst stimulation can provide patients additional options to effectively manage their chronic pain,” said Timothy R Deer, president and chief executive officer of The Centre for Pain Relief in Charleston, West Virginia, and Chairman of the SUNBURST study. “Many US pain physicians and their patients have long been hopeful for new options to treat chronic pain, and now the SUNBURST trial has clinically demonstrated that Burst stimulation is a meaningful therapy to support improved management of chronic pain while reducing, and in the majority of patients eliminating, paraesthesia.”
The SUNBURST study was designed to assess the effects of Burst stimulation from St Jude Medical, and enrolled 100 patients from 20 centres across the United States randomised to either receive tonic stimulation prior to Burst stimulation, or to receive Burst stimulation prior to tonic stimulation. After six months, an analysis of the first 85 patients to complete their 24 week visit showed Burst stimulation delivered:
- Pain relief: The study met its primary endpoint of non-inferiority and achieved statistical significance for its pre-specified secondary endpoint of superiority demonstrating patients receiving St. Jude Medical’s Burst stimulation achieved superior pain relief and greater treatment success when compared to patients receiving traditional SCS.
- Patient preference: A statistically significant majority of patients (69.4%) in the SUNBURST study preferred Burst stimulation to tonic SCS for the treatment of chronic pain.
- Reduced paraesthesia: The vast majority (91%) of patients reported a decrease in paraesthesia during treatment with Burst stimulation relative to tonic SCS. In addition, 65% of SUNBURST patients were paraesthesia free while using Burst stimulation from St. Jude Medical.
“St Jude Medical is committed to developing solutions that can reduce the effect of complex epidemic diseases while improving patient care, and providing new treatment options for patients suffering from chronic pain is central to that goal,” said Allen Burton, medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “The results of the SUNBURST study have provided strong confirmation that our Burst stimulation therapy yields direct benefits for patients while offering superior pain relief and improved quality of life.”
The proprietary Burst stimulation developed by St Jude Medical uses intermittent ”burst” pulses designed to mimic the body’s natural nerve firing patterns and provide a more physiologic therapy method for chronic pain conditions. The results of the SUNBURST study are being used to support St Jude Medical’s application for FDA approval of Burst therapy feature in products such as the Prodigy rechargeable SCS devices.