On May 16, 2023, the US Food and Drug Administration (FDA) approved spinal cord stimulation (SCS) devices from the pharmaceutical company Abbott for the treatment of chronic back pain in people who have not had or are not eligible for receiving back surgery, per a press release from Abbott. The approval was granted after a six-month study of 200 participants showed spinal cord stimulation provided significant relief and improvements in pain, function, quality of life and mental health.
Those enrolled in the study had experienced an average of nearly 13 years of disabling chronic back pain. Participants were ineligible for corrective back operations because they were medically frail or had numerous degenerative changes in their spine, none of which were severe enough to qualify for corrective surgery but still caused significant symptoms.
After six months, 85 percent of those implanted with Abbotts SCS devices achieved a significant reduction in back pain, compared with only 7 percent who received conservative medical management. On average, people who received SCS therapy experienced about a 70% reduction in pain.
Historically, people who have no options for corrective surgery to address their chronic back pain are typically treated with combination therapies: physical therapy and chiropractic care, injections and pain relievers, says Allen Burton, MD, division vice president and chief medical officer. of Abbott\’s neuromodulation activity. However, these options are not effective for a significant subset of people who previously lacked other therapies, making the treatment pathway complicated and uncertain for others. People who suffer from chronic back pain and don\’t meet typical surgical criteria tend to forgo future care, eventually resigning themselves to living with chronic debilitating pain.
The US Pain Foundation estimates that approximately 50 million Americans live with chronic back pain.
While many people suffer from 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 identify 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 chronic pain relief for some people.
Advancement of an old concept
While the use of electrical stimulation for pain relief may seem modern, research indicates that the idea dates back to ancient Rome, when physician Scribonius Largus discovered that the pain of gout could be relieved by contact with torpedo fish (known as also as an electric ray), which can stun other animals with a natural electric charge.
It wasn\’t until 1968, however, that the Medtronic company introduced the first commercially available spinal cord stimulator.
Abbott\’s latest SCS devices use proprietary BurstDR pacing technology, the first to use pulses of mild electrical energy to mimic the body\’s normal electrical signals, masking those that signal pain as they travel to the brain.
Michael Leong, MD, a pain specialist at the Stanford Cancer Center in California who was not involved in Abbott\’s research, notes that the pulse systems are different from previous spinal stimulation technologies in that the patient does not feel the stimulation.
Other earlier systems used something called tonic stimulation, which created a tingling that patients could feel, says Dr. Leong. With these new waveforms, you can\’t feel the sensation.
Leong adds that the significant reduction in physical pain provided by this type of stimulation can also help reduce emotional symptoms.
Many people with chronic pain develop symptoms of depression and anxiety, she says. If a device can relieve not only physical pain but also the accompanying emotional pain, that\’s a huge plus.
As mental and physical health improves, so do quality of life and productivity.
How the device is implanted
People with chronic back pain who are interested can first try the technology for 7-10 days, and if it feels beneficial, the device can then be implanted. Dr. Burton compares the implantation process to getting a cardiac pacemaker. He stays with the patient so that he can deal with the pain continuously.
The procedure is not very intrusive, according to Leong.
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 our iPhone batteries.
The device is often placed just under the skin on the back or buttock. The device\’s thin wires are placed in the spine near the nerves that carry pain signals. The electronics send continuous electrical impulses that interrupt pain signals before they can reach the brain.
Typical implant time for an SCS device is one to two hours. These procedures are usually done on an outpatient or overnight basis.
Potential limitations of spinal cord stimulation
This latest FDA stamp of approval for Abbott covers all of the devices the company currently offers in the US, including its Proclaim Plus implant (with a battery that lasts up to 10 years) and its Eterna rechargeable system.
While these devices are quickly gaining federal approval, Mark Queralt, MD, director of the Musculoskeletal Institute and clinical director of back and neck pain at Dell Medical School at the University of Texas at Austin, urges consumers to exercise caution and to consider all the evidence on these enhancers.
The results of Abbott\’s latest study are limited, he says, because they reflect responses from just 200 people. Results from 2,000 or more patients would make better sense if this technology offers benefits in a real-world scenario, she says.
Queralt questions the value of this type of therapy based on research suggesting that spinal cord stimulation does not result in a lower level of opioid use, pain injections or spinal surgery. He also cautions about the price of such therapy, which according to industry analysis can cost $39,000 more in the first year than conventional medical therapy.
People who have had chronic pain for years are desperate for anything. Hope is a powerful motivator and that gives them hope, she says. I\’m not overly optimistic about this technology. See all the evidence. Time will tell on this one.
Leong recommends that those suffering from chronic back pain should in good conscience try more conservative approaches first, such as physical therapy and medication. But if those don\’t work and if you don\’t plan on getting any type of corrective surgery or needing it, this can be a great option, he says.
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