Spinal Cord Stimulators

New uses and expanded approval for an established pain treatment… but is the jury still out on safety and effectiveness?

Earlier this year, Nature Medicine published an exciting study that showed promising results for stroke patients receiving spinal cord stimulation.

Although the trial was small and preliminary (only two patients), researchers at the University of Pittsburgh and Carnegie Mellon found that electrodes implanted along the spinal cord to deliver stimulation helped stroke victims suffering from weakness and paralysis improve mobility and dexterity and make quicker, more intentional movements.

Each year, stroke affects 12 million people worldwide, 800,000 in the United States alone; 75% experience impairment such as weakness or paralysis in hands or arms, which can be long-term. Globally, 1.5 billion people are living with stroke-related physical damage.

Although the patients in the trial had suffered different types of strokes, both regained control of a disabled arm with spinal cord stimulation. They showed improvement during treatment and lasting effects even after the devices were removed, indicating that the treatment may be both assistive and restorative.

Similar studies have produced positive outcomes in restoring leg and foot movement in individuals paralyzed by spinal cord injury.

Spinal Cord Stimulation for Pain Relief

According to data from the U.S. Pain Foundation, more than 50 million people in the U.S. suffer from chronic pain.

Spinal Cord Stimulators (SCS) have been used for over five decades in treating numerous types of chronic pain—heart pain, diabetic or cancer-related neuropathy, failed back surgery syndrome, pain after amputation, and more. Implanted in the body by a healthcare provider, an SCS device may help alleviate pain “after nonsurgical pain treatment options have failed to provide sufficient relief,” according to Johns Hopkins Medicine.

SCS sends a mild electrical impulse along the spinal cord to interrupt the pain signal before it reaches the brain. “Traditional spinal cord stimulators replace the sensation of pain with light tingling, called paresthesia,” explains Johns Hopkins.

However, over the last year, the FDA has given successive approvals to an innovative SCS technology developed by Abbott. BurstDR uses “pulses—or bursts—of mild electrical energy” and does not cause paresthesia.

Most recently, in May, BurstDR approval was expanded to include a new category of patient for SCS: those with pain that has not been previously treated with surgery or who are, for various reasons, ineligible for corrective surgery, known as “nonsurgical back pain.”

People who suffer chronic, inoperable back pain often undergo multiple therapies, including physical therapy, pharmaceutical pain relievers, and chiropractic care. However, even in combination, these treatments are not always effective for severe pain, and the use of opioids carries a risk of addiction and other adverse side effects. Chronic pain can have devastating psychological effects, disrupt sleep, and negatively impact the quality of life overall. Low back pain is a leading cause of disability worldwide, according to the WHO.

Abbott’s research on BurstDR, which studied 200 patients with an average of 13 years of nonsurgical back pain, found that nine out of ten showed significant improvement, including an average 70% reduction in pain 12 months out.

In a press release, Abbott said, “BurstDR™ SCS technology improved pain levels, ability to perform daily activities, and emotional well-being in people with chronic back pain.”

Questions remain about safety and effectiveness

While it may sound like a miracle treatment, SCS has critics. In March, a Cochrane Review by the University of Sidney found “Spinal cord stimulation, a medical technology suggested to treat people with chronic back pain, does not provide long-term relief and may cause harm.” Analyzing results from 13 different clinical trials and data from 699 participants, the Cochrane team compared the effectiveness of SCS with placebos and no treatment, concluding that “spinal cord stimulation is no better than a placebo for treating low back pain.”

A 2018 Associated Press investigation found that SCS devices “account for the third-highest number of medical device injury reports to the U.S. Food and Drug Administration, with more than 80,000 incidents flagged since 2008,” STAT News reported.

Further, in 2020 the FDA itself published a review indicating they’d received over 100,000 medical device reports (MDR) involving adverse events with SCS, “including 497 associated with a patient death, 77,937 with patient injury, and 29,294 with device malfunction;” over a third involved unsatisfactory pain relief. They explicitly advise healthcare providers to conduct a trial with each patient before implanting an SCS device.

A 2022 study from the University of California San Francisco (UCSF) School of Medicine found that, in 1260 patients who had received permanent SCS implants, the device did not reduce the use of other treatments, including injectable pain relief, epidurals, opioids, radiofrequency ablation, or opioids after two years (compared to a control group); 20% had severe complications requiring the device to be altered or removed.

Many SCS trials have been relatively short-term (less than six months) or have assessed only immediate impacts. There are still considerable unknowns and conflicting evidence.

The experienced and compassionate personal injury attorneys at Aitken * Aitken * Cohn have decades of experience representing clients in medical malpractice and product liability suits, including using dangerous or misapplied medical devices. Contact our spinal cord stimulator injury attorneys if you or someone you love has been hurt.

By Aitken Aitken Cohn