Lower back pain now treated by implantable nerve stimulation device

The recently approved ReActiv8 Implantable Neurostimulation system, now available at UCHealth, is a new option for patients with chronic low back pain.
July 20, 2021

Daniel Montoya was a young man living in New Mexico when he went to the oilfields to make a living doing what he describes today as “back-breaking work.” In the early 1990s he departed the state for Colorado, where he began a new career in law enforcement.

Montoya, now 49, has been a parole officer for the State of Colorado for the past 15 years. His days as an oil hand in New Mexico are far behind him, but for many years he has had an unwelcome memory of his youthful work: persistent lower back pain.

“It was always there,” Montoya said. “I got used to it, but some days were much worse than others. I would lie or sit in a certain position for a while and then I couldn’t stand up.”

Chronic low back pain that can’t be treated with surgery is a common problem. Courtesy Getty Images.
Chronic low back pain that can’t be treated with surgery is a common problem. Photo: Getty Images.

Montoya tried to treat the pain with physical therapy and medications – which he disliked taking – but couldn’t find relief. Nor did he have a clear problem, like a compressed nerve, that could be corrected with surgery. So for many years he lived with the discomfort, even as it put a damper on activities like water sports and playing with his son, who is now 12.

Lower back pain and a possible solution

It’s a common dilemma for many people, said Dr. Vikas Patel, a spine surgery specialist and professor with the Department of Orthopedics at the University of Colorado School of Medicine. Patel said he sees large numbers of patients with chronic back pain at the UCHealth Spine Center – Anschutz Medical Campus, but he can’t give them all straightforward solutions for their problems.

UCHealth spine surgeon Dr. Vikas Patel, led the ReActiv8 trial for the CU Department of Orthopedics. Photo courtesy of UCHealth.
UCHealth spine surgeon Dr. Vikas Patel, led the ReActiv8 trial for the CU Department of Orthopedics. Photo courtesy of UCHealth.

“Some patients have a clear pathology, with a clear source of pain and a clear indicator for surgery – like a herniated disc,” Patel said. “But we also have a large group of non-surgical patients with back pain that doesn’t get better with treatments like physical therapy. We’ve had no great answer for those patients.”

That could change with the successful completion of a multi-site clinical trial of a new device designed to help patients like Daniel Montoya. The ReActiv8 Implantable Neurostimulation System, approved by the FDA last summer, uses electrical signals to rehabilitate and strengthen the weakened deep lower-back muscles, called the multifidus, that lie beside the spine. The idea: stronger muscles help to lessen pain.

“We’ve seen pretty dramatic improvements,” said Patel, who was principal investigator for the CU Department of Orthopedics trial site. “It’s been nice to see how patients have recovered and had a gradual reduction in their symptoms.” Patel said the hospital in mid-May approved offering the device to new patients.

Electrical signals stimulate muscles

How does it work? Patel said patients require an outpatient surgery, during which he first implants leads next to the dorsal ramus nerves outside the spinal canal. These nerves feed the lower-back muscles. The leads connect to a battery pack and minicomputer that Patel implants in the patient’s side with a second incision. Patients use a remote control to turn on this device, which signals the nerves to fire and stimulate the muscles, prodding them to rebuild. Think of it as rehabilitation with a remote control.

In the trial, patients in the study group used the device for two 30-minute sessions, once before bed and once before getting up, for 120 days. A control group received a lower stimulation dose for the 120-day period, then transitioned to the full dose. The patients also kept pain journals and returned for check-ups at 180, 240 and 365 days and now do so annually.

Assessments of their pain and their function each showed meaningful improvements, according to the FDA and to study results presented in an article co-authored by Patel and published in March in the journal Pain. Nearly half of the patients also reduced or eliminated their use of opioids to manage their pain. Those in the trial now use the stimulation on an as-needed basis.

A nerve stimulator, not a scrambler

The ReActiv8 device uses implanted leads and a battery pack to supply nerve stimulation that helps to alleviate chronic back pain. Image courtesy of Mainstay Medical.
The ReActiv8 device uses implanted leads and a battery pack to supply nerve stimulation that helps to alleviate chronic back pain. Image courtesy of Mainstay Medical.

Patel said ReActiv8 also offers an alternative to spinal cord stimulation, which uses electrodes implanted on top of the spinal cord that are attached to a battery pack. When the device fires, it scrambles the pain signals the spine sends to the brain. That can be effective, but the approach doesn’t address the problem of muscles weakened by years of chronic pain.

“In some ways, that’s a Band-Aid we’ve used to block sensation,” Patel said. “ReActiv8 uses muscle-building stimulation versus entry-signal scrambling.”

Welcome relief for chronic pain

Whatever the mechanisms, Daniel Montoya said he found relief with the ReActiv8 device. He discovered the trial about three years ago in a Facebook post, contacted Patel’s team for more information and qualified for enrollment. The first 120 days were a bit of a challenge, partly because it was difficult to stick to the treatment schedule. He also had to get used to the sensations he felt when the device stimulated his lower-back muscles.

“At first it felt like an elephant stepping on my lower back,” he said. “I could feel the pressure going on and off.” But the pain gradually lessened, and he soon learned to use the stimulation only when he needed it. If he’s had a tough day, for example, he uses it before bed.

“When I get up the next morning, I’m fine,” he said.

As for the long years of chronic pain, Montoya said he believes they are behind him, and he credits ReActiv8.

“Right now, I have no back pain,” he said. “It’s not a concern for me. The pain relief I get is immediate. It’s like having a therapist [massaging] right on your spine or disc.”

Patel said he envisions more people like Montoya who are not candidates for surgery gaining relief from the device for their chronic lower-back pain.

“It could be used on a daily, routine basis, like exercise,” he said. “It’s easy to see how hundreds of patients might benefit from it.”

For more information about the ReActivat8 device, contact the UCHealth Spine Center at 720.848.1980.

About the author

Tyler Smith has been a health care writer, with a focus on hospitals, since 1996. He served as a writer and editor for the Marketing and Communications team at University of Colorado Hospital and UCHealth from 2007 to 2017. More recently, he has reported for and contributed stories to the University of Colorado School of Medicine, the Colorado School of Public Health and the Colorado Bioscience Association.

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