Lower back pain is now treated by the implanted nerve stimulation device

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

Montoya, now 49, has been a conditional officer for the state of Colorado for the past 15 years. His days as an oilman in New Mexico are far behind him, but for many years he has an unwanted memory of his youthful work: constant back pain.

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

Chronic low back pain that cannot be treated with surgery is a common problem. Photo: Getty Images.

Montoya tried to treat the pain with physical therapy and medication – which she did not like to take – but found no relief. Nor did he have a clear problem, like a compressed nerve, that could be corrected with surgery. So for many years he lived in discomfort, even though he put up an obstacle for activities like water sports and games with his son, who is now 12 years old.

Pain in the lower back and a possible solution

It’s a common dilemma for many people, said Dr. Vikas Patel, a specialist in spinal surgery and professor in the Department of Orthopedics at the University of Colorado School of Medicine. Patel said he sees a large number of patients with chronic back pain at the UCHealth Spine Center – Anschutz Medical Campus, but he can not give them all direct solutions to 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 indication for surgery – like a disc herniation,” Patel said. “But we also have a large group of non-surgical patients with back pain that do not improve with treatments like physical therapy. We have not had any excellent responses 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 muscles of the lower back, called multifidus, that lie near the spine. The idea: stronger muscles help reduce pain.

“We’ve seen quite dramatic improvements,” said Patel, who was the CU orthopedics Department’s chief investigator for the trial. “It has been good to see how patients have recovered and have had a gradual reduction in their symptoms.” Patel said the hospital in mid-May approved the provision of the device for new patients.

Electrical signals stimulate muscles

How does it work? Patel said patients require an outpatient operation, during which he implants for the first time near the dorsal ramus nerves outside the spinal canal. These nerves nourish the muscles of the lower back. The drivers are connected to a battery pack and minicomputer that Patel implants on the patient side with a second incision. Patients use a remote control to turn on this device, which signals nerves to turn on and stimulate muscles, prompting them to rebuild. Think of it as remote control rehabilitation.

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

Assessments of pain and their function each showed significant improvements, according to the FDA and the results of the study presented in an article co-authored by Patel and published in March in the journal Pain. Almost half of the patients also reduced or eliminated their opioid use to manage their pain. Those on trial now use incentives based on need.

A nerve stimulator, not a scrambler

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

Patel said ReActiv8 also offers an alternative to spinal cord stimulation, which uses electrodes implanted at the top of the spinal cord that are attached to a battery pack. When the device fires, it rubs the pain signals that the back sends to the brain. This may be effective, but the approach does not address the problem of weakened muscles from years of chronic pain.

“In some ways, this is a Band-Aid we used to block the feeling,” Patel said. “ReActiv8 uses stimulation of muscle building versus incoming signal collisions.”

Welcome relief for chronic pain

Whatever the mechanism, Daniel Montoya said he found relief with the ReActiv8 device. He revealed the trial about three years ago in a Facebook post, contacted Patel’s team for more information and qualified to sign up. The first 120 days were a bit challenging, in part 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 muscles in his lower back.

“At first it felt like an elephant was stepping on my lower back,” he said. “I can feel the pressure going on and on.” But the pain gradually diminished, and he quickly learned to use stimulation only when he needed it. For example, if he has had a hard day, 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 trusts ReActiv8.

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

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

“It can be used on a daily, routine basis, as exercises,” he said. “It’s very easy to see how hundreds of patients can benefit from it.”

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

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