Daniel Montoya was a young man living in New Mexico when he went to the oil field to make a living, doing what he calls “hard work” today. In the early 1990s, he left the state for Colorado, where he started a new law enforcement career.
Montoya, 49, has served as Colorado’s parole officer for the past 15 years. Gone are the days when he worked as an oil worker in New Mexico, but over the years he has unwelcome memories of his young job: persistent low back pain.
“It’s always there,” Montoya said. “I’m used to it, but some days are much worse than others. I will lie down or sit in a certain position for a while, and then I can’t get up.”
Montoya tried to treat the pain with physiotherapy and medicine-he didn’t like taking it-but couldn’t relieve it. He also has no obvious problems, such as nerve compression, which can be corrected by surgery. As a result, he has endured discomfort for many years, even though it hindered activities such as water sports and playing with his 12-year-old son.
Low back pain and possible solutions
Dr. Vikas Patel, an expert in spine surgery and a professor of orthopedics at the University of Colorado School of Medicine, said that for many people, this is a common dilemma. Patel said that he saw a large number of patients with chronic back pain at the UCHealth Spine Center-Anschutz Medical Park, but he was unable to provide all direct solutions to their problems.
Patel said: “Some patients have clear pathology, clear source of pain, clear surgical indicators-just like a herniated disc.” “But we also have a large group of non-surgical patients with back pain who have undergone physical therapy and other treatments. No improvement. For these patients, we have no good answers.”
This may change with the successful completion of a multi-site clinical trial of a new device designed to help patients such as Daniel Montoya. The ReActiv8 implantable neurostimulation system, which was approved by the FDA last summer, uses electrical signals to repair and strengthen the weakened deep lower back muscles called the multifidus muscle located next to the spine. The idea: stronger muscles help reduce pain.
“We have seen very significant improvements,” said Patel, the principal investigator of the CU Orthopedic Testing Center. “It’s great to see how patients recover and gradually reduce their symptoms.” Patel said the hospital approved the device for new patients in mid-May.
Electrical signals stimulate muscles
How does it work? Patel said the patient needed outpatient surgery, during which he first implanted a wire next to the dorsal branch nerve outside the spinal canal. These nerves provide energy for the lower back muscles. The wire is connected to the battery pack and the microcomputer, and Patel implants it on the patient’s side through a second incision. The patient uses the remote control to turn on the device, and it sends signals to the nerves, stimulates the muscles, and stimulates them to rebuild. Think of it as using a remote control for rehabilitation.
In the trial, patients in the study group used the device for two 30-minute sessions, one before going to bed and one before waking up for 120 days. The control group received a lower stimulation dose during 120 days and then transitioned to the full dose. The patient also keeps a pain diary and returns for examination after 180, 240, and 365 days, which is now done every year.
According to the findings presented in an article co-authored by the FDA and Patel and published in the journal in March, the evaluation of their pain and function showed significant improvement painNearly half of the patients also reduced or eliminated the use of opioids to control pain. Those who participated in the trial now use stimuli as needed.
Nerve stimulator, not scrambler
Patel said that ReActiv8 also provides an alternative to spinal cord stimulation, which uses electrodes implanted at the top of the spinal cord and connected to the battery pack. When the device is activated, it disrupts the pain signals that the spine sends to the brain. This may be effective, but this method does not solve the problem of muscle weakness due to years of chronic pain.
“In some ways, this is the band-aid we use to stop feeling,” Patel said. “ReActiv8 uses muscle exercise stimulation instead of entering signal disturbance.”
Welcome to relieve chronic pain
Regardless of the mechanism, Daniel Montoya said he found relief from the ReActiv8 device. About three years ago, he discovered the experiment in a Facebook post, contacted Patel’s team for more information, and was eligible to register. The first 120 days were a bit challenging, partly because it was difficult to stick to the treatment plan. When the device stimulates his lower back muscles, he must also get used to how he feels.
“At first it felt like an elephant was stepping on my lower back,” he said. “I can feel the constant changes in pressure.” But the pain gradually eased, and he soon learned to use stimulation only when needed. For example, if he had a difficult day, he would use it before going to bed.
“When I got up the next morning, I was fine,” he said.
As for the long-term chronic pain, Montoya said he believes they have passed and he believes in ReActiv8.
“Now, I don’t have back pain,” he said. “This is not a problem for me. The pain relief I get is immediate. It’s like having a therapist [massaging] Right on your spine or intervertebral discs. “
Patel said he envisions more people like Montoya who are not suitable for surgery from the device to relieve chronic low back pain.
“It can be used daily and routinely like exercise,” he said. “It’s easy to see how hundreds of patients benefited from it.”
For more information about the ReActivat8 device, please contact the UCHealth Spine Center at 720.848.1980.