Dr. Richard H. Bundschu is fortunate enough to experience the best of both worlds — patient interaction and scientific research participation — on a daily basis.
As a board certified interventional pain management specialist for Coastal Orthopedics, Dr. Bundschu has spent more than 20 years treating patients with chronic neck and spinal pain. Serving in private practice has allowed Dr. Bundschu to help patients determine the source of their discomfort and provide them with the means to improve their quality of life.
Additionally, Coastal Orthopedics has its own research department, allowing Dr. Bundschu to be a part of groundbreaking research studies outside of a traditional university setting.
“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,” says 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.’”
Most recently, Dr. Bundschu was one of 9 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.
“I’m also a scientist so of course research is fascinating,” adds Dr. Bundschu. “What’s nice about Coastal Orthopedics is that we are able to participate in some really impressive studies without being under the umbrella of the university. It’s really rewarding and exciting to be a part of that, and it puts us on the cutting edge of medicine.”
The select physicians were chosen to validate real-world results utilizing Nevro’s HF10 technology with Dr. Bundschu having some of the best results in the world. Eight sites across three countries, including the U.S., Germany and the United Kingdom, participated in the study with each site having at least 100 implanted patients over a two-year period.
HF-SCS 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.
Spinal cord stimulators work by applying an electrical current to the spinal nerves, which disrupts the flow of pain signals that travel to the brain. To install a stimulator, a thin electrode is inserted into the epidural space where the lumbar and thoracic space meet.
The electrodes are attached to a small battery implanted in the body, above the hip and below the rib cage in the area typically referred to as a “love handle,” that stimulates the spinal canal and nerve roots, disrupting and significantly diminishing a patient’s pain.
Patients are then given a remote control where they can select a series of programs, ranging from one to five, depending on their level of pain.
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.
Spinal cord stimulators have been on the market for roughly 30 years, but it wasn’t until recently that physicians really began delving into the various options available and the substantial role spinal cord stimulators can play in the reduction of chronic neck and spinal cord pain.
Prior to 2009, there were three brands of spinal cord stimulators on the market: Medtronic, Boston Scientific and St. Jude Medical, now known as Abbot. The three spinal cord stimulators were similar in that they are all relatively low frequency with the maximum frequency registering 1250 Hz or less.
Nevro introduced a new high-frequency spinal cord stimulator in 2009, and in 2015, following a randomized, controlled trial of the lower back of which Dr. Bundschu was a leading researcher, the groundbreaking product earned U.S. Food and Drug Administration approval.
What makes the Nevro spinal cord stimulator different than traditional spinal cord stimulators is the higher frequency, resulting in a unique waveform. Prior to this technology, patients would feel paresthesia, often described as tingling or buzzing, in the back and lower extremities. With Nevro’s HF10 therapy, the tingling and buzzing is eliminated and patients feel instant relief.
Dr. Bundschu has been a leading pain management researcher for several years and previously worked with Nevro on two studies. 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.
Recently, Nevro submitted the results of a landmark clinical trial to test the effectiveness of spinal cord stimulators in treating ongoing upper extremity pain. Dr. Bundschu was the principal investigator for the study, as Coastal Orthopedics was one of six companies nationwide selected to participate. Dr. Bundschu says he expects the results to be published in summer 2019.
“This is cutting-edge research,” says Dr. Bundschu. “This is a device that’s very high-tech and a good fit for those people who have tried everything else. If there’s an option that improves quality of life and takes patients off pain medication, that is a great option. You just have to choose your patients wisely.”