Restorative neurostimulation
ReActiv8
A minimally invasive implant designed to address mechanical chronic low back pain associated with multifidus muscle dysfunction.
- Restorative approach
- Outpatient implantation
- Two 30-minute sessions daily
The stabilizing muscles of the low back
What is multifidus dysfunction?
The multifidus muscle is the key stabilizing muscle in the lower back. A single injury to the back can cause impaired muscle control of the multifidus. This lack of muscle control can decrease the spine’s functional stability, leaving the spine susceptible to further injury and overloading.
Mechanical chronic low back pain results from an injury or stress on tissues surrounding the spine, including soft tissues, muscles, bones, and joints. Often, this type of pain is due to impaired neuromuscular control and neural inhibition of the multifidus.
Muscle pain vs. nerve pain
Mechanical pain can present differently from neuropathic pain. A focused exam and review of imaging or physiological testing help clarify the cause.
Clinical cues
Do these symptoms sound familiar?
The partner materials suggest looking for a pattern of back-dominant pain, muscle fatigue, and instability that worsens with ordinary sustained positions or small tasks.
01
Frequent back pain or muscle spasms
A recurring pattern of back-dominant discomfort or muscle spasm.
02
Feelings of instability
A sense that the lower back is not providing reliable support.
03
Pain with small daily tasks
Discomfort while brushing teeth, washing dishes, bending, or reaching.
04
Pain while sitting or driving
Increasing discomfort during sustained seated positions.
05
Needing arm support
Using the arms for support or changing positions frequently.
Assessment
Your doctor can assess the multifidus
Physical tests and imaging may help confirm whether multifidus dysfunction is present.
Treat the cause, not only the symptoms
What is ReActiv8 restorative neurostimulation?
ReActiv8 is designed to address the underlying cause of mechanical low back pain by helping patients restore neuromuscular control of the multifidus muscle.
By stimulating the medial branch nerves that activate the multifidus, the therapy is intended to help the body regain control of the muscle and improve functional lumbar stability.
How the therapy is delivered
Implanted once. Activated at home.
The device is implanted underneath the skin during a minimally invasive outpatient procedure. A generator connects to two leads positioned to stimulate the nerves controlling the multifidus muscle.
01
Outpatient procedure
Implanted beneath the skin.
02
Targeted leads
Placed by nerves outside the spinal canal.
03
Patient remote
The patient controls each therapy session.
04
Daily therapy
Two 30-minute sessions per day.
Approved patient education series
Understand the pain pathway
Mainstay supplied these exact Vimeo videos for partner websites.
Neuromuscular control
Proprioception and back muscles.
Multifidus dysfunction
Loss of neuromuscular control.
Restorative vs. palliative
Treatment options for chronic low back pain.
RESTORE randomized evaluation
One-year study context
Mainstay Medical reports one-year outcomes from a randomized comparison of ReActiv8 and optimal medical management.
Patient-reported improvement
~9 in 10
ReActiv8 patients reported noticing improvement, many “much improved” or “very much improved.”
ReActiv8 group
52%
Experienced resolution of pain, defined in the source as an NRS score of 3 or less.
Medical-management group
6%
Of patients continuing optimal medical management reached the same low pain level.
Source: Schwab F, Mekhail N, Patel KV, et al. Pain and Therapy (2025). doi:10.1007/s40122-024-00689-0. Results from a study population do not predict individual outcomes.
Think restorative sooner
Could multifidus dysfunction be contributing to your low back pain?
A targeted exam can help distinguish mechanical muscle dysfunction from other pain sources.
Important safety and indication information
U.S. indication: ReActiv8 is an implantable neurostimulation system that employs a restorative therapy designed to restore muscle control of the lumbar spine for improved low back pain management. It is indicated for bilateral stimulation of the L2 medial branch of the dorsal ramus as it crosses the transverse process at L3 as an aid in management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing, in adults who have failed therapy including pain medications and physical therapy and are not candidates for spine surgery.
ReActiv8 is a prescription device implanted by certified physicians in an outpatient setting. Patients should discuss whether it is appropriate with their healthcare provider. Surgery carries risk and outcomes vary.
ReActiv8 is a registered trademark of Mainstay Medical.