MONDAY, Feb. 6, 2023 (HealthDay News) — After living with disabling low back pain for nearly 30 years, Dennis Bassett, 64, has finally found a new lease of life.
The Hempstead, NY resident injured his back in the 1980s while helping a friend. He tried everything to relieve his back pain, from self-medication, acupuncture, and chiropractor work to steroid injections, physical therapy, and exercise.
“My back just got worse,” the retired real estate professional recalls. “Some days I could barely get into the house and up the stairs.”
Everything changed a few months ago after his doctor suggested a new procedure in which a muscle-stimulating device called the ReActiv8 was implanted in his lower back to activate a dormant and atrophied core muscle. The US Food and Drug Administration nodded to the device in June 2020.
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The father of six underwent the procedure several months ago at Lenox Health Greenwich Village in New York City. Now he is considering moving south and starting a trucking business.
“I feel good enough that I can take a chance,” he said. “I can walk upstairs, sit down and get up without any problems. I thought, ‘this is too good to be true.’”
But when combined with the right patient, this procedure isn’t too good to be true, said Bassett’s surgeon, Dr. Kiran Vishal Patel, director of pain medicine at Lenox Hill Hospital in New York City.
“This is an unprecedented procedure because it is restorative, disease-modifying, can prevent further degeneration and allows people to be so much more active than they were,” she said.
It’s not for everyone with lower back pain, Patel said. “This procedure is for patients who have had persistent low back pain for more than six months and have not responded to physical therapy, anti-inflammatory medication and all the typical conservative things we do,” she explained. They also show no signs of structural damage on MRI scans.
People like Bassett have a weak multifidus muscle in their lower back. This muscle is essential for walking, sitting and bending.
“If we can activate the multifidus muscle with ReActiv8, we can break the cycle of pain and allow the patient to regain core stability so they don’t develop further injuries to discs, nerves or facet joints in their back,” said Patel.
During the outpatient procedure, a surgeon implants the ReActiv8 pulse generator, which is about the size of a small dental floss, into the patient’s lower back and then places an electrode on each side of the multifidus muscle. The generator delivers electrical pulses to the nerves to activate the multifidus muscle.
Patients use a wireless remote control twice a day for 30 minutes to contract and relax their muscle, making it stronger. There is little downtime after the procedure. Most people feel mildly sore for a few days.
There is one possible downside: the cost. The surgery can be expensive. Patel is working to get more private insurance companies to foot the bill. Insurance companies that cover neurostimulation typically pay anywhere from $20,000 to $32,000 for the procedure. If insurance is not an option, Mainstay Medical will work on a sliding scale with the patient, surgeon or hospital to cover costs, a company spokesperson said.
There haven’t been many great treatments for lower back pain caused by a weak multifidus muscle, said Dr. Dawood Sayed, chief of pain medicine at the University of Kansas Health System in Tulsa. He participated in clinical studies leading to the approval of this device and performed more than 60 on- and off-study procedures.
“This fills a gap in our treatment algorithm,” Sayed said.
The device is intended for patients with chronic low back pain who are not candidates for traditional spine surgery and who experience more pain in their lower backs than in their legs, he noted.
“In a certain subset of patients, physical therapy, exercise, yoga, chiropractic care, medications and even injections may not get that muscle to fire correctly,” Sayed said. “The device hijacks the process with tiny electrical wires to stimulate the nerve that essentially controls the main muscle.”
How do you know who will benefit from this procedure? The decisive factor is the state of the multifidus muscle in the lower back. “The MRI is helpful because we’ll see if the muscle has become thinner or atrophied, because it’s more like muscle is being replaced by fat,” he said.
Pain relief after the procedure occurs gradually and lasts at least three years, according to studies. “Patients are doing well at one year, even better at two years, and the three-year data shows continued improvements,” Sayed said. In a company study, 83% of patients experienced “substantial and clinically meaningful improvements” in pain or disability, or both, after three years.
“This is the first neurostimulator implant that is more of a restorative therapy to get people back to where they were and get the muscles working,” he added.
And some people can have the device removed after the pain has subsided.
Sayed is confident that more commercial insurers will start covering the costs of the procedure. “It’s cost-effective because it means people don’t go to the emergency room, take pain medications or miss work because of back pain,” he said.
The American Academy of Orthopedic Surgeons has more information on treating low back pain.
SOURCES: Dennis Bassett, Hempstead, NY; Kiran Vishal Patel, MD, director of pain medicine, Lenox Hill Hospital, New York City; Dawood Sayed, MD, chief of pain medicine, University of Kansas Health System, Tulsa