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FDA Approves Neurostimulation System to Treat Chronic Low Back Pain

August 31, 2020
The new ReActiv8 device may provide welcome relief to those who have failed other back pain interventions and who have difficulty exercising.

with Ramon Cuevas-Trisan, MD

With millions of Americans experiencing intractable chronic lower back pain, and no single strategy recognized to effectively address the problem, ReActiv8 may offer some hope for individuals whose symptoms have failed to respond to other, more conventional therapeutic methods.


FDA granted premarket approval in June 2020 to Mainstay Medical Holdings on its ReActiv8 device, an implantable neurostimulation system to treat intractable chronic lower back pain (LBP). This device is expected to hit the US market in early 2021, according to a press release provided by Mainstay, which is headquartered in Dublin, Ireland.

ReActiv8 may be a significant development for adults with chronic low back pain who have not had success controlling the pain using other treatment options.

The Need for Lower Back Pain Treatments

For people whose LBP is predominantly mechanical in nature, only a small number of therapies currently exist, including exercise, complementary/alternative medicine, minimally invasive procedures, and surgery. Many of these approaches are not fully effective, causing this population to rely on medications that attempt to mask the pain but do not resolve it. Further, some patients who have not been able to find relief using current treatment modalities have become dependent on opioids to control their pain. (See also, the updated NASS guidelines on low back pain.)

Ramon Cuevas-Trisan, MD, director of Education & Research for the West Palm Beach VA Medical Center, pointed out that the upcoming availability of ReActiv8 may provide this population with a potentially safer way to address the pain – and hopefully to improve their quality of life in the process.

“Lower back pain is the most common musculoskeletal complaint among adults, with a lifetime prevalence of approximately 60 to 70% percent in industrialized countries. There are many causes to blame, but the most common ones are related to lifestyle (lack of exercise/sedentarism, excessive sitting, smoking, obesity), poor posture and biomechanics, and stress. Regardless of the cause, it is one of the top origins of loss of productivity and health care expenditures worldwide,” Dr. Cuevas-Trisan said.

One of the challenges inherent in treating LBP is that it is not a disease entity in itself; rather, it’s a symptom caused by one of many neuromusculoskeletal conditions affecting a wide range of structures in the lumbosacral region of the lower torso. This has made it difficult to find consensus in the medical community on how to effectively treat the issue.

The Mechanism of ReActiv8: Blunting Pain, Activating Muscles

ReActiv8 is different from other minimally invasive forms of treatment modalities used today because it relies on a unique mechanism to address LBP. Dr. Cuevas-Trisan explained that instead of focusing on a sensory target to dull the pain generated by a specific structure, it seeks to blunt pain by passively activating muscles in order to promote strengthening and increase stability of the spine.

The ReActiv8 procedure involves implanting two electrodes into the deepest layer of muscles in the lumbar area in order to provide stimulation to the L2 medial branch of the dorsal ramus nerve as it crosses the transverse process at L3. This nerve supplies the lumbar multifidus muscle, a key stabilizing muscle of the lower back. These electrodes are connected to a battery-operated electrical pulse generator that is implanted under the patient’s skin, similar to a pacemaker. 

“This pulse generator delivers an electrical current to the electrodes and the nerves are activated, resulting in muscle contractions that are expected to strengthen the muscles and promote stability of the spine,” Dr. Cuevas-Trisan said.

He pointed out that, as such, this treatment could potentially meet the need of promoting strengthening of spinal/core stabilizer muscles.

While similar results may be obtained using an individualized physical therapy program focused on active exercises, the value of ReActiv8 is that the procedure and device may be able to achieve this passively, without the patient having to exercise, he added.

ReActiv8 Clinical Trial Results

A multicenter international clinical trial of ReActiv8 conducted by the manufacturer demonstrated promising results with this method, although more research is needed to fully understand the full potential of the procedure and the device.

In reviewing the data, Dr. Cuevas-Trisan observed that patients with LBP who received treatment with the ReActiv8 procedure reported better (subjective) pain relief than those receiving the placebo or inactive treatment. Of note, however, is that the trial used an active control group as comparison and there was statistically significant pain reduction among the treatment group in the cumulative response analysis but not in the primary endpoint of 30% pain score reduction.

“The ‘active control’ is perhaps the best option but is not a true placebo because it involved implantation of the electrodes and pulse generator (exactly the same as the active group), but the pulse generator in these subjects was programmed to deliver an intermittent electric pulse as opposed to two 30-minute electrical stimulation sessions per day,” explained Dr. Cuevas-Trisan.

Overall, he finds the potential of ReActiv8 to be very promising. “It’s a highly innovative treatment, based on a completely different approach to invasive pain management. It represents a complete paradigm shift,” he added. This could provide welcome relief to those who suffer the most from severe low back pain.

Last updated on: October 1, 2020
Continue Reading:
Chronic Low Back Pain: Can We Find a Treatment Consensus?
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