A restorative treatment for mechanical CLBP

The information on this page is intended for Physicians.

ReActiv8 is an effective and durable treatment for your patients with mechanical Chronic Low Back Pain (CLBP) and multifidus muscle dysfunction.

ReActiv8 restorative neurostimulation treatment to treat the cause of back pain

What is ReActiv8?

ReActiv8 is designed to treat chronic low back pain in patients diagnosed with dysfunction of the multifidus, which is the primary muscle responsible for lumbar spinal stability. ReActiv8 aims to reduce pain and improve related disability and quality of life. This therapy can provide an effective treatment solution for your patients with mechanical CLBP.

How is it different?

ReActiv8 – a device that uses a restorative treatment approach that targets underlying multifidus muscle dysfunction. Analgesic (or palliative) treatment options have limited effectiveness and durability in patients with mechanical CLBP. [1]rnrnu0026nbsp;rnrn1 – Jensen MP, Brownstone RM. Mechanisms of spinal cord stimulation for the treatment of pain: Still in the dark after 50 years. European Journal of Pain (United Kingdom) 2019;23:652–9.

How does it work?

The ReActiv8 therapy targets the multifidus muscle with electrical pulses delivered through proprietary self-anchoring lead technology placed adjacent to the medial branch of the dorsal ramus. Post procedure, your patient conducts their own at-home therapy twice daily for 30 minutes per session.

Compelling Patient Outcomes

ReActiv8-B clinical trial patient outcomes after three years.

The ReActiv8-B Clinical Trial is an international, multi-center, randomized, active-sham controlled blinded trial comparing the ReActiv8 therapy Treatment Group to an active sham Control Group.

Long-Term Treatment Benefits

  • ReActiv8® provides an effective, durable, and safe treatment option for carefully selected patients with intractable CLBP and multifidus muscle dysfunction.
  • Trajectory and durability of clinical benefits are consistent with restoration of neuromuscular control and muscle rehabilitation.
  • Restorative neurostimulation does not appear to be susceptible to loss of
    efficacy (i.e., decreasing effectiveness over time).
  • The safety profile of the therapy remained favorable compared to available implantable neurostimulators for the treatment of other types of back pain.
  • An increasing proportion of participants are eliminating or decreasing opioid consumption.
Outcome measure comparison by year Mainstay Medical Australia
recovery profile consistent with restorative therapy Mainstay Medical Australia

Gilligan C., Volschenk W., Russo M., Green M., Gilmore C., Mehta V., Deckers K., De Smedt K., Latif U., Sayed D., Georgius P., Gentile J., Mitchell B., Langhorst M., Huygen F., Baranidharan G., Patel V., Mironer E., Ross E., Carayannopoulos A., Hayek S., Gulve A., Van Buyten J.-P., Tohmeh A., Fischgrund J., Lad S., Ahadian F., Deer T., Klemme W., Rauck R., Rathmell J., Schwab F., Maislin G., Heemels J.P., Eldabe S. 2022. Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction.
Neuromodulation 2022; -: 1–11.


Multifidus Dysfunction: Loss of Neuromuscular Control

Multifidus Dysfunction can result from a loss of neuromuscular control. This can cause a lack of spinal support, leading to uncontrolled loading of spinal joints and discs, resulting in mechanical low back pain.

The ReActiv8 clinical trial demonstrates long-term efficacy of ReActiv8 restorative neurostimulation
Play Video about The ReActiv8 clinical trial demonstrates long-term efficacy of ReActiv8 restorative neurostimulation


Innovation Leads to Rehabilitation

ReActiv8 aims to break the cycle of mechanical CLBP through it’s restorative approach. Here’s how.

Clinical Trial of the ReActiv8 innovation leads to rehabilitation and what is the multifidus muscle Mainstay Medical Australia
Play Video about Clinical Trial of the ReActiv8 innovation leads to rehabilitation and what is the multifidus muscle Mainstay Medical Australia


See the patient's stories firsthand

ReActiv8 implanters and their clinical staff have seen patients’ lives change after treatment with ReActiv8. Watch their stories below about their experience with mechanical CLBP. The following videos contain stories from three of our international patients who experienced remarkable results from the ReActiv8 system. Patients’ stories are theirs only and not indicative of the results for all patients. Patient outcomes will vary.


Frequently Asked Questions

Reactiv8 is a treatment for adults with intractable mechanical chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing. Candidates for the therapy have failed interventional treatment options including pain medications and physical therapy and are not indicated for spine surgery.

On average, people with CLBP who were treated with ReActiv8 Restorative Neurostimulation therapy had substantial reductions in pain, and improvements in disability and quality of life after one year. Given the restorative nature of the therapy, it may take some time for the pain relief and improvements in function to be experienced by the patient.

ReActiv8 is currently listed on the prostheses list. If the patient is an Australian citizen or permanent resident, Medicare and/or their private health insurance provider may partially or completely cover the costs of the procedure. The amount covered will vary based on the patient to which you should provide the patient with informed financial consent prior to treatment advising what their charges will be and what out-of-pocket expenses the patient may incur.

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