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FDA Approves New Implant for Treating Chronic Low Back Pain

Original article published by Very Well Health, July 10, 2020 on

By Daniel Dowling

Lower back pain is a silent affliction that most people experience. According to a study published in BMJ Clinical Evidence, seven out of every ten people will suffer from low back pain at some point in their lives. And of those, 7% will develop chronic low back pain (CLBP).

Treatments for CLBP include physical therapy, stretching and cortisol shots to reduce pain and inflammation. But these treatments aren’t 100% effective, and many people don’t have access to them.

In special circumstances, neurostimulation is now approved as a treatment for chronic lower back pain.

The Food and Drug Administration (FDA) recently announced the approval of a new implant aimed at treating CLBP, called ReActiv8. Developed by Mainstay Medical, ReActiv8 is an implantable neurostimulation system that improves CLBP associated with multifidus muscle dysfunction. (We’ll explain what this means in just a bit.)

This decision to approve ReActiv8 for CLBP came from results obtained in clinical trials of the device over a four month period. Researchers conducted the trials across Europe, Australia and the United States, and recruited 204 adult participants suffering from CLBP. According to the press release from Mainstay Medical, the results showed that ReActiv8 therapy reduced feelings of pain and disability in most participants—an improvement that persisted for over a year.

Results from the clinical trials are not currently available to the public.

Why This Matters

  • Many patients who have failed physical therapy and are ineligible for spine surgery are forced to take opioids to manage their pain in lieu of other options. With lower back implant devices such as ReActiv8, these people have hopes of living pain-free lives once again.

The Origins of Chronic Low Back Pain

ReActiv8 works by sending electrical signals that stimulate dormant nerve tissue within the multifidus.

The deep multifidus muscle (specifically, the section in the lower back) is one of the most important stabilizers of the lumbar spine—critical for walking, sitting, and especially bending. When this muscle atrophies from lack of use or degrades from overuse/injury, people commonly experience impaired motor control in the lower back.

Experts say this impaired control is one of the key underlying causes of CLBP.

“Research shows that the multifidus gets turned off and becomes latent in people with pain,” Theresa Marko, DPT, board-certified clinical specialist in orthopedics and owner of Marko Physical Therapy, tells Verywell. “This drives a snowball effect where more weakness leads to greater pain."

The immobility and pain of chronic low back pain forces many people into disability and isolation. ReActiv8 is proven to offer relief in these cases.

How ReActiv8 Works

The core function of this implant is to revive the contracting abilities of the multifidus, which makes lumber spine control possible again. Matt Onaitis, CFO Mainstay Medical, the manufacturer of ReActiv8, spoke with Verywell about specifics of the device and how it works.

“The implanted pulse generator provides electrical stimulation to the dorsal ramus nerve,” Onaitis says, referring to the nerve that runs through the multifidus. He says that this stimulation induces “repetitive contractions of the multifidus muscle,” which amounts to a micro-workout session for the lower back. The end result is more strength, more control, and less pain—an effective reversal of the ‘snowball effect’ that Marko referenced.

Onaitis says treatment sessions last for 30 minutes and are activated by the patient twice per day via remote control. Data from clinical trials confirm that this treatment length is sufficient to promote lasting improvements for pain, disability, and quality of life in those suffering from CLBP.

But How Exactly Does It Help With Pain?

The implant works with what is known as the gate control theory of pain, Derrell Blackburn, DC, senior manager of chiropractic relations and training for The Joint Chiropractic, tells Verywell.

“By stimulating the muscle in a way to promote motion, you are activating mechanoreceptors that essentially turn off our pain-causing input,” Blackburn says. This activity directly affects the function of the lower and upper motor neurons, “which has the potential to support potential changes in quality of life and the healing process,” he adds.

  • While neurostimulation isn’t exactly new, what makes ReActiv8 relevant today is that it’s treating the underlying, neuromuscular causes of back pain, rather than simply masking pain for the short term.

Who Is Eligible for the Implant?

ReActiv8 is a last-resort treatment option for adults who have had no success with other therapies and are not eligible for spine surgery.

“In any pain management case, we want to consider the most conservative, non-invasive therapies first and work our way toward implants and surgeries,” Blackburn says.

So if your symptoms are recent and you haven’t been treated, your first line of action should be to see your physical therapist.

“We assess alignment, strength, and function to tailor treatments to what that specific person needs,” Marko says of her physical therapy practice. She said that all 50 states allow for direct access for physical therapists, meaning you don’t have to wait for a doctor’s referral to get the help you need.

Does It Work for All Back Pain?

The short answer is no. According to Onaitis, the pain has to be associated with multifidus muscle dysfunction. (He mentioned that this disclaimer is printed clearly on the product labeling.) But experts say that electro-stimulation therapy via ReActiv8 could theoretically have broader applications.

“It’s a common misconception that any type of back pain can be treated in isolation,” Blackburn says, explaining that muscles work synergistically. “So if the multifidus is dysfunctional, the surrounding muscles, such as those in the middle and upper spine, are working harder in effort to compensate.”

While ReActiv8 is clinically tested for pain resulting from a weakened multifidus, it’s possible that future trials of the device could reveal benefits for other types of back pain as well.

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