BRADENTON, Fla. — Dr. Richard H. Bundschu, an interventional pain management specialist with Coastal Orthopedics, was one of nine physicians worldwide whose high-frequency spinal cord stimulation (HF-SCS) research was recently published in the Annals of Clinical and Translational Neurology, an open-access journal of the American Neurological Association.
Select physicians were chosen to validate real-world results utilizing Nevro’s HF10 technology, and Dr. Bundschu has some of the best results in the world. High-frequency spinal cord stimulation at 10 kHz has been proven effective in the treatment of chronic back and leg pain in a randomized, controlled trial. Prior to this study, however, large observational studies had yet to be performed and published.
“I’m very flattered,” said Dr. Bundschu. “I didn’t even realize they were looking at my clinical results, but I’m very humbled and honored to be a part of this research and to be included in this group of prominent and experienced doctors.”
During the real-world, multicenter study, 1,660 patients with chronic trunk and/or limb pain were implanted with HF-SCS at 10 kHz. Of the 1,660 patients who were implanted, approximately 100 were Dr. Bundschu’s patients. These patients were not part of the Nevro study — a landmark clinical trial to test the effectiveness of the Silicon Valley-based medical device company’s spinal cord stimulators in treating ongoing upper extremity pain for which Dr. Bundschu is one of the principal investigators.
Patients involved in the study received a temporary stimulator for 6-10 days to see if the procedure was for them. The patients that elected to move forward received a permanent spinal cord stimulator a few weeks later.
Patients’ responder rates were then evaluated 3, 6 and 12 months post-implantation. Data was collected from eight participating centers across three countries during a 4-year period between April 2014 and January 2018.
“These cases were done in real life,” said Dr. Bundschu. “This topic is similar to the randomized, controlled trial, but the article is different in that this research looks at patients who got the spinal cord stimulator put in for real life and how they are doing.”
Every Nevro patient is assigned a patient number and is followed through NevroCloud to ensure they receive the best possible results. At the end of the review, more than 70 percent of patients treated with HF-SCS experienced at least 50 percent pain relief throughout the 12 months of follow-up. The majority of the patients also reported an improved quality of life, specifically in terms of function and the ability to sleep comfortably.
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 the lower back, that have helped the company’s groundbreaking products earn U.S. Food and Drug Administration approval. The results of the real-world multicenter review were consistent with Dr. Bundschu’s findings during the randomized, controlled trial, which only further validates his research results.
“As a physician, what really motivates me as a chronic pain interventional spine doctor is being able to do something that returns quality of life to the patient,” said Dr. Bundschu. “Nothing makes me prouder than being able to do something really simple like putting in a device and having a patient come to me and say ‘I can make my bed without any pain’ or ‘I don’t need pain medication anymore.’”
About Coastal Orthopedics
Founded in 1973 and based in Bradenton, Fla., Coastal Orthopedics is home to 17 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 40 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 International 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