BRADENTON, Fla. — Dr. Richard H. Bundschu, an interventional pain management specialist with Coastal Orthopedics, was one of 12 physicians nationwide whose high-frequency spinal cord stimulation research was recently published in Neurosurgery, the official journal of the Congress of Neurological Surgeons.
Select physicians were chosen to validate utilizing Nevro’s HF10 technology, a paresthesia-independent therapy, in the treatment of neck and upper limb pain. High-frequency spinal cord stimulation at 10 kHz has been proven effective in the treatment of chronic back and leg pain. Prior to this trial, however, a study of pain in the cervical spine had yet to be performed and published.
Coastal Orthopedics was one of six medical centers across the nation to participate in the landmark study, which began in June 2015. The Nevro study was the first of its kind to prospectively report pain relief, responder rates and quality of life in patients with pain in the cervical spine. Each of the previous studies had been done within the thoracic spine to treat back and/or leg pain. Neck pain is still considered an off-label indication.
“I’m very pleased, flattered and proud of this study,” said Dr. Bundschu. “Our results were consistent, which is very important. This puts us on the map and highlights the world-class research that we are doing here at Coastal Orthopedics. It’s awesome knowing we’re getting great results for those patients that need it.”
HF10 therapy is unique in that in addition to eliminating the need to establish paresthesia mapping and coverage, it also eliminates the risk of uncomfortable stimulation due to positional variation, which can compromise neck and upper limb pain relief with low-frequency spinal cord stimulation.
During the prospective, multicenter study, 45 patients with chronic, intractable neck and/or upper limb pain were implanted with two epidural leads at different points along the cervical spine between the C2 and C6 vertebrae.
Those patients with successful trial stimulation, resulting in at least 40 percent reduction in upper limb and/or neck pain, received Nevro’s Senza system and were evaluated to assess the safety and effectiveness of the 10 kHz spinal cord stimulation system in the treatment of neck and/or upper limb pain.
Patients’ responder rates were then evaluated on the 3-month, 6-month and 12-month post-implantation marks. Enrollment in the study concluded in January 2017 with the final patient completing their 12-month post-implantation visit in March 2018.
Following the study, patients with neck pain reported a 79.1 percent pain relief while those with upper limb pain experienced 85.9 percent pain relief. Additionally, the percent of pain relief gradually increased from the three-month visit to the 12-month visit. More importantly, 89.2 percent of patients with neck pain and 95 percent of patients with upper limb pain reported approximately 50 percent pain relief at 12 months.
The majority of patients also reported improvement in both quality of life and ability to sleep comfortably while 30 percent of patients either decreased or eliminated their opioid medication.
Dr. Bundschu has been a leading pain management researcher for several years and previously worked with Nevro on two studies, including a 2012 randomized, controlled trial on lower back pain, that have helped the company’s groundbreaking products earn U.S. Food and Drug Administration approval. The results of the high-frequency spinal cord stimulation at 10 kHz study were superior to those that Dr. Bundschu and his team tabulated during that landmark study.
“The amazing thing about this study is that it was more successful than the lumbar study,” said Dr. Bundschu. “When patients were asked to evaluate their pain on a scale of 0 to 10, lumbar patients went from an 8 down to a 2.3 while cervical patients went from an 8 to a 1.9. That’s impressive.”
About Coastal Orthopedics
Founded in 1973 and based in Bradenton, Fla., Coastal Orthopedics is home to 19 orthopedic surgeons and pain management physicians who maintain hospital affiliations with Blake Medical Center, Manatee Memorial Hospital and Lakewood Ranch Medical Center. In addition to three offices and two ambulatory surgery centers each servicing Florida’s West Coast, Coastal Orthopedics’ board-certified and fellowship-trained physicians and surgeons provide patients with the very latest in pain and orthopedic treatment technology. The company strives to repair and heal injuries relating to the entire musculoskeletal system. For more than 45 years, its highly skilled staff of physicians and surgeons has treated patients in specialty care, including sports medicine, joint replacement, pain management and rehabilitation. Patients can experience restoration of function both surgically and non-surgically through the use of physician-guided strengthening, therapy, medications, injections and stretching. For more information, please visit CoastalOrthopedics.com or call 941-792-1404.
About Dr. Richard H. Bundschu
Dr. Richard H. Bundschu is an internationally recognized leader in pain management who is proficient with spinal injections, facet injections, radio-frequency vertebroplasty and kyphoplasty and implantable spinal cord stimulators. He received his doctor of medicine from the University of Miami, where he also completed a residency in anesthesia and a fellowship in pain management. As a recognized expert, he trains other pain management physicians for the Spinal Interventional Society and maintains board certifications with the American Board of Anesthesiology, the American Board of Pain Medicine, the American Board of Pain Management and the American Board of Interventional Pain Physicians.