Cover Story: First in Florida
New device offers long-term pain relief, alternative to opioids
or decades, chronic back pain dominated Felix Favicchio’s life. On most nights, sleep came fitfully. Simply lying in bed brought searing torment. His days weren’t much better.
“On a good day, I would try to get up and do something. I would have to go back in the house. I couldn’t do anything because of the pain,” the 58-year-old said.
All of that changed Sept. 27, when Favicchio became the first person in Florida to receive a new neurostimulation implant for people living with chronic back pain. Neuromodulation works by delivering low doses of mild electrical pulses to change pain signals as they travel from the spinal cord to the brain.
The outpatient procedure was performed at University of Florida Health by anesthesiologist Ajay B. Antony, M.D. Abbott’s Proclaim XR system was approved in late September by the U.S. Food and Drug Administration.
What makes the Proclaim XR system different is its longevity: Doctors can find the lowest effective dose of stimulation, which allows the spinal cord stimulation device to remain powered for up to 10 years.
Neurostimulation has another advantage: less reliance on opioid pain medications, which have been a scourge in the U.S. for years. More than 30% of Americans have chronic and acute pain, according to The New England Journal of Medicine. Neurostimulation devices can reduce dependence on opioids for chronic pain management and prevent the need for increasingly larger doses of pain medication.
In Florida, a state whose demographics include a high percentage of elderly residents as well as others suffering from chronic pain, being the first to offer this advancement puts UF Health among the national leaders in combating the opioid crisis.
“We are now capable of treating a larger number of patients and providing a higher degree of pain relief,’’ Antony said. “University of Florida Health has been a leader in advancing the field.”
'Too many' surgeries
Favicchio has spent most of his adult life battling back pain. It started with an injured spinal disk after a construction accident at age 24. Over the years, he tried everything to get relief — operations, rehabilitation, opioid pain relievers, massage therapy and muscle relaxants. Several years ago, doctors inserted screws and metal rods near his spine.
On his back, scars bear witness to what he has endured on operating tables. Asked how many surgeries he had over the years, he says simply, “Too many.”
On a scale of 1 to 10, the pain was a constant 7, he said. And it wasn’t his alone. Favicchio and his wife, Josephine, used to walk 3miles each night. That eventually ended, along with the gardening Felix enjoys so much.
The constant pain, Felix said, made him angry all the time.
“He wasn’t happy, so I wasn’t happy,’’ Josephine said. “The pain changed his whole demeanor.”
In July, things got worse. Favicchio was involved in a hit-and-run car crash that made his back pain spike.
“It was out of control — a shooting pain from my neck all the way down to my feet,” he said.
After testing Burst DR stimulation on a trial basis and finding that it gave Favicchio some relief, Antony moved ahead with a permanent implant of the Proclaim XR.
During a 90-minute procedure, Antony made two small incisions and placed a small device called an implantable pulse generator about three-fourths of an inch beneath the skin in Favicchio’s lower back.
Using a continuous X-ray imaging known as fluoroscopy, Antony guided a series of insulated wires from the device into place. His target: the epidural space, an area around the spinal nerves that is commonly used to block pain. Favicchio had only light sedation, similar to what is used during a colonoscopy.
'Putting water on fire'
The Proclaim XR is a result of advances in neuromodulation research and technology, said Antony, an assistant professor in the UF College of Medicine’s anesthesiology department. Delivering smaller electrical pulses gives high-quality pain relief to patients while also allowing the devices to last for years without recharging.
The Proclaim XR also is more transparent for patients: New technology means they no longer feel a tingling sensation as the device works to block pain signals. Because the device is so efficient — it provides the lowest effective dose of pain-reducing electrical pulses — patients are no longer tethered to a recharging system every day or once every few days while the battery replenishes.
“The goal is to decrease pain and, more importantly, allow patients to do things that they enjoy or haven’t been able to do before. The fact that Felix won’t have to spend time maintaining a device allows him to accomplish his goal of being more active,” Antony said.
On Oct. 2, Favicchio’s neuromodulator was activated for the first time. Using an Apple iPad mini and a proprietary app, Abbott representative Dallas Graham customized the settings to begin delivering pain relief.
“Tell me when you start to feel some relief,“ she told Favicchio.
“The pain, it’s going away,“ he said, excitedly. “This is what I
Using the iPad, Graham adjusted the amplitude, or intensity, of the neurostimulation. As the pain he had known for decades began ebbing, a smile crossed his face.
“It’s like putting water on a fire,”
Although neurostimulation isn’t new, Antony said patients are now reaping the benefits of recent technological advances in neuromodulation pain relief. Rechargeable devices debuted about 20 years ago, but they typically need to be powered up every one to two days. Abbott’s system lets doctors choose the lowest effective dose of stimulation for a patient. Using lower doses of energy in shorter cycles enables the Proclaim XR’s long battery life.
While the device might not completely end a patient’s pain, Antony said it provides a meaningful reduction that will unquestionably help Favicchio and other patients with chronic pain. Since Favicchio’s implant, eight to 10 other patients have gotten the devices implanted through late October.
An opioid alternative
The device’s arrival is also encouraging because research shows that spinal cord stimulation reduces patients’ need for opioid pain relievers, Antony said. An estimated 1.7 million people in the U.S. had substance abuse issues involving prescription opioids in 2017, according to the National Institute on Drug Abuse.
In early 2017, researchers at Thomas Jefferson University in Philadelphia found that one year after getting an implant, 93% of patients who continued their spinal cord stimulation therapy used fewer opioid doses than those who had their devices removed.
Among the 5,476 patients in the Abbott-sponsored study, average daily opioid use declined or stabilized for 70% of patients with spinal cord stimulators. Those who had their stimulators removed used more opioids than those who kept the devices, the researchers noted. The findings were published in the April 2018 edition of the journal Pain Medicine.
The modern era of neurostimulation dates to the 1960s, when deep brain stimulation was pioneered for chronic pain. Soon after, spinal cord stimulation came into widespread use.
Neurostimulation devices in general can have a positive impact on patients who might otherwise turn to medication, said Rene Przkora, M.D., Ph.D., chief of pain medicine and an associate professor of anesthesiology in the UF College of Medicine.
“Neurostimulation has been shown to decrease opioid use and improve patients’ quality of life,” he said.
The technique is useful for more than just chronic back pain. It can also help to address pain caused by nerve damage or a malfunctioning nervous system, discomfort from surgical procedures such as knee replacement, and complex regional pain syndrome — a type of chronic that affects the arms and legs, Przkora said.
Neurostimulation devices can also be implanted in an array of patients, from the very young to seniors, according to Przkora.
“Ten years ago, there was nothing that we could do for some patients. Now, there are options for more of them,” he said.
Returning to a normal life
Antony said he often recommends a spinal cord stimulator to wean a patient off opioid pain medication.
“It’s also a way to prevent patients from ever starting down the road of opioid use,” Antony said.
Despite his pain, Favicchio said he used painkillers sparingly.
“They didn’t seem to help much. I would take them for a couple of days, as few as possible. I didn’t want to risk getting addicted,” he said.
A week after the implant was activated, Favicchio was able to stop taking his medication for nerve pain. His pain dropped to 1 on the 1 to 10 scale. By the last week of October, the pain was less than a 1.
“I’m sleeping better. I have a lot more energy. I feel like a brand-new person,” he said.
His wife is already making plans. Felix can finally work on the tile countertops his wife wants in their house near Gainesville. He’ll also be tending his garden once again. Tomatoes and peppers are his specialty.
“We’re looking forward to getting back to our normal life,” she said.