Those who participated in the trial suffered from chronic back pain for an average of nearly 13 years. Participants were ineligible for corrective back surgery because they were either medically frail or because they had numerous degenerative changes in their spine, none of which were severe enough to qualify for corrective surgery, but nevertheless caused significant symptoms.
After six months, 85 percent of those implanted with Abbott’s SCS devices achieved significant reductions in back pain, compared to only 7 percent who received conservative medical treatment. On average, people who received SCS therapy experienced about a 70 percent reduction in pain.
“Historically, people who don’t have options for corrective surgery to address their chronic back pain have typically been treated with combinations of therapies: physical therapy and chiropractic care, injections and pain medications,” said Allen Burton, MD, the vice president and chief of the medical associate division of Abbott’s neuromodulation company. “However, these options are ineffective for a significant proportion of people who previously had no other therapies available, while for others the treatment path feels complicated and uncertain. People who suffer from chronic back pain – who do not meet typical surgical criteria – have the tend to forego future treatments, eventually resigning themselves to living with debilitating chronic pain.
The US Pain Foundation estimates that approximately 50 million Americans live with chronic back pain.
While many people experience chronic back pain due to arthritis, spinal stenosis, or disc problems, the cause of chronic back pain can sometimes be difficult to pinpoint, often making it difficult to determine a clear treatment plan. Dr. Burton notes that doctors may recommend more conservative approaches to managing chronic back pain through exercise, physical therapy or chiropractic care, pharmaceutical management, and injections. However, even a combination of these conservative measures may not be enough to provide relief from chronic pain for some people.
Progression of an old concept
While the use of electrical stimulation to relieve pain seems modern, research indicates that the idea dates back to ancient Rome, when the physician Scribonius Largus discovered that gout pain could be relieved through contact with the torpedo fish (also known as an electric ray), it can stun other animals with a natural electrical charge.
However, it was not until 1968 that the Medtronic company introduced the first commercially available spinal cord stimulator.
Abbott’s latest SCS devices use patented BurstDR stimulation technology, the first to use pulses of mild electrical energy to mimic the body’s normal electrical signals, mimicking the signals that signal pain as they travel to the brain. masked.
Michael Leong, MD, a pain specialist at Stanford Cancer Center in California who was not involved in Abbott’s research, notes that the pulse systems differ from previous spinal stimulation technologies in that the patient does not feel the stimulation.
“Other previous systems used something called ‘tonic stimulation’, which produced a tingling sensation that patients could feel,” says Dr. Leong. “With these newer waveforms, you can’t feel the sensation.”
Leong adds that a significant reduction in physical pain from this type of stimulation can also help reduce emotional symptoms.
“Many people with chronic pain develop symptoms of depression and anxiety,” he says. “If a device can relieve not only physical pain, but also the emotional pain that comes with it, that’s a huge benefit.”
As mental and physical health improve, so does quality of life and productivity.
How the device is implanted
People with chronic back pain who are interested can try the technology for 7 to 10 days first, and if it feels right, the device can be implanted. Dr. Burton compares the implantation process to getting a pacemaker. It stays with the patient so that it can continuously treat the pain.
According to Leong, the procedure is not very drastic.
“The devices are very, very small,” he says. “They used to be the size of a hockey puck, but now they’re the size of the batteries in our iPhones.”
The device is often placed just under the skin of the back or buttock. Thin wires from the device are placed in the spine near the nerves that transmit pain signals. The electronics send out continuous electrical pulses that disrupt pain signals before they can reach the brain.
The typical implantation time for an SCS device is one to two hours. These procedures are usually performed on an outpatient or overnight basis.
Potential limitations of spinal cord stimulation
This latest FDA stamp of approval for Abbott covers all devices the company currently offers in the United States, including the Proclaim Plus implant (with a battery that lasts up to 10 years) and the rechargeable Eterna system.
While these devices are quickly gaining federal approval, Mark Queralt, MD, the director of the Musculoskeletal Institute and clinical director of back and neck pain at the Dell Medical School at the University of Texas at Austin, urges consumers to exercise caution and the evidence about these stimulators.
These latest study results from Abbott are limited, he says, because they reflect the responses of only 200 people. Results from 2,000 patients or more would give a better picture if this technology offers benefits in a real-world scenario, he says.
Queralt questions the value of this type of therapy based on research suggesting that spinal cord stimulation does not reduce levels of opioid use, pain injections, or spinal surgery. He also cautions about the price of such therapy, which can cost $39,000 more than conventional medical therapy in the first year, according to industry analysis.
“People who have had chronic pain for years are desperate for everything. Hope is a powerful motivator and this gives them hope,” he says. “I am not too optimistic about this technology. Look at all the evidence. Time will tell.”
Leong recommends that people with chronic back pain “in good conscience” first try more conservative approaches, such as physical therapy and medications. “But if these don’t work, and if you don’t think you’ll have or need corrective surgery, this could be a good option,” he says.