In the year On May 16, 2023, the US Food and Drug Administration (FDA) approved spinal cord stimulation devices from pharmaceutical company Abbott to treat chronic back pain in people who have not had or are ineligible for back surgery. Press release of Abt. After a six-month study of 200 participants, the approval showed significant relief of spinal cord stimulation and improvements in pain, function, quality of life and mental health.
Those enrolled in the trial had experienced disabling chronic back pain for an average of 13 years. None of the participants were eligible for definitive back surgery because they were medically frail or had multiple degenerative changes in the spine, but were developing significant symptoms.
After half a year, 85 percent of those implanted with Abbott SCS devices achieved a significant reduction in back pain, while only 7 percent received conservative medical management. On average, people who received SCS treatment experienced a 70 percent reduction in pain.
“Historically, people who did not have the option of corrective surgery to address their chronic back pain were often treated with medical methods such as physical therapy and chiropractic care, injections and pain medication,” said Allen Burton, division vice president and chief executive officer. Medical Officer of Abbott Neuromodulation Business. “However, these options are ineffective for a significant proportion of people who have not previously had other treatments, making the treatment journey complex and uncertain for others. “Those who suffer from severe back pain – and who do not fit the criteria for conventional surgery – forego future treatment, leaving themselves to live with debilitating chronic pain.”
The US Pain Foundation estimates that nearly 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 identify, often making it difficult to identify a clear treatment plan. Dr. Burton says doctors may recommend more conservative approaches to managing chronic back pain with exercise, physical therapy or chiropractic care, pharmaceutical administration and injections. However, even a combination of these conservative measures may not be enough to relieve chronic pain for some people.
The development of an old concept
Using electrical stimulation to relieve pain may seem modern, but research shows that the idea dates back to ancient Rome. A natural electrical charge can stun other animals.
It wasn’t until 1968 that the Medtronic company introduced the first commercially available spinal cord stimulator.
Abbott’s latest SCS devices use their patented BurstDR stimulation technology, the first to use mild electrical energy to mimic the body’s normal electrical signals, masking pain signals as they travel to the brain.
Michael Leong, M.D., a pain specialist at Stanford Cancer Center in California, who was not involved in the Abobot study, said the pulse systems differ from previous spinal cord stimulation technologies in that the patient does not feel the stimulation.
“Other previous systems created a sting that patients could feel, using something called ‘tonic stimulation,'” Dr. Leong said. “With these new waves, you can’t feel it.”
Leong says the significant reduction in physical pain delivered through this type of stimulation can also help reduce emotional symptoms.
“Many people with chronic pain experience symptoms of depression and anxiety,” he says. “If the device can relieve not only physical pain, but the emotional pain that goes with it, that’s a huge benefit.”
As mental and physical health improves, so does quality of life and productivity.
How to install the device
People with chronic back pain who are interested can first try the technology for 7 to 10 days, and if you feel it is useful, the device can be implanted. Dr. Burton compares the implant process to getting a heart transplant. He stays with the patient so that he can treat the pain continuously.
According to Leong, the procedure is not very invasive.
“The tools are very, very small,” he says. “It used to be the size of a hockey puck, but now it’s the batteries in our iPhones.”
The device is usually placed under the skin on the back or under the skin. The thin wires from the device are placed in the spinal cord near the nerves that carry pain signals. The electronics send continuous electrical impulses that disrupt the symptoms before they reach the brain.
Typical installation time for an SCS device is one to two hours. These procedures are performed on an outpatient or overnight stay.
Possible limitations of spinal cord stimulation
This latest FDA seal of approval for Abbott includes all of the devices the company currently offers in the US, including the ProClay Plus implant (with a battery that lasts up to 10 years) and the rechargeable Eterna system.
Although these devices are rapidly gaining federal approval, Mark Quellt, MD, director of the Muscular Institute and clinical director of back and neck pain at the University of Texas at Austin’s Dell School of Medicine, urges consumers to be cautious and think about all the information. These stimuli.
Abbott says the results of the latest study are limited because they reflect responses from 200 people. Results from 2,000 patients or more will give a better impression if this technology is useful in a real-world setting, he said.
Queralt questions the value of this type of treatment based on studies showing that spinal cord stimulation does not result in lower opioid use, pain injections or spinal surgeries. He also warns about the cost of such treatment, which, according to an industry analysis, can cost $39,000 more than conventional medical therapy in the first year.
“People who have had chronic pain for years are desperate for anything. Hope is a powerful motivator, and this gives them hope,” he says. “I’m not overly optimistic about this technology. Look at all the evidence. Time will tell about this. “
Leong recommends that people with chronic back pain first “in good conscience” try conservative approaches such as physical therapy and medications. “But if these don’t work and you don’t think you’re going to have some kind of corrective surgery, this can be a great option,” he said.
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