BRADENTON, Fla. — The Silicon Valley-based medical device company Nevro has selected Coastal Orthopedics Sports Medicine and Pain Management (CoastalOrthopedics.com) to participate in a landmark clinical trial to test the effectiveness of the company’s spinal cord stimulators in treating chronic neck and arm pain. This study may lead to a major shift in how pain management physicians help their patients deal with ongoing upper extremity body pain.
The Nevro study, which began in June, involves up to 75 patients in the U.S., 10 -15 of whom are patients of Dr. Richard H. Bundschu, an interventional pain specialist with Coastal Orthopedics. Dr. Bundschu has been a leading pain management researcher for several years and has worked with Nevro on two previous studies that have helped the company’s groundbreaking products earn U.S. Food and Drug Administration approval.
Developed in the 1960s and first approved by the FDA in 1989, 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, physicians insert thin electrodes through an incision in the back and then thread the electrodes next to the spinal column. The electrodes are attached to a small battery implanted in the body that sends the signal that disrupts pain.
Overall, chronic pain affects approximately 100 million Americans. Spinal cord stimulators have been used to treat chronic pain in the lower back, torso and legs when pain medication, physical therapy and injections are ineffective. Historically, less than one percent of Dr. Bundschu’s patients have been candidates for spinal cord stimulators.
“Chronic pain is a nightmare. It just makes people miserable,” says Dr. Bundschu. “Patients who are candidates for a spinal cord stimulator have tried everything to get relief, and nothing works. One of the reasons I became a pain management physician was because of the incredible positive impact that stimulators can have on a person’s quality of life. The patient becomes themselves again.”
Based in Menlo Park, Calif., Nevro’s innovative Senza® spinal cord stimulation system delivering HF10™ therapy has won recognition for the way in which their high-frequency stimulators offer relief without causing paresthesia, a constant tingling sensation common to other companies’ stimulators. In the most recent Nevro Study in which they participated, Dr. Bundschu and his colleagues at Coastal Orthopedics implanted nine Senza systems.
Coastal Orthopedics’ current research trial will test the use of HF10 therapy to treat neck and arm pain. The study is scheduled to take two years to complete.
“This is exciting stuff, and it places Coastal Orthopedics on the cutting edge of pain management research around the world,” says Dr. Bundschu. “Our work with Nevro shows that serious medical research doesn’t just occur in university settings. At Coastal Orthopedics, we perform top-notch patient care day in and day out while also pushing the boundaries of medicine with our research.”
About Coastal Orthopedics Sports Medicine & Pain Management
Founded in 1973 and based in Bradenton, Florida, Coastal Orthopedics is home to 16 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, our 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, 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.