A rehabilitative 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.

What is ReActiv8?

ReActiv8 Restorative Neurostimulation is a rehabilitative therapy designed to address impaired neuromuscular control and degeneration of the multifidus muscle linked to mechanical chronic low back pain (CLBP). The ReActiv8 system overrides underlying multifidus inhibition by eliciting episodic, isolated contractions which, over time, can facilitate recovery from mechanical CLBP. This therapy can provide an effective treatment solution for your patients with mechanical CLBP.

How is it different?

ReActiv8, the only FDA-approved rehabilitative device of its kind, 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]

 

1 – 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 one year

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.

The one-year data supports that ReActiv8 is a rehabilitative therapy where progressive improvement can be expected over time, both in magnitude of effect and the proportion of patients who benefit from the treatment. Now physicians finally have a treatment option to provide their patients with a long-term solution for mechanical CLBP that is designed to provide relief from the debilitating cycle of muscle inhibition and pain. See the data for this effective and durable therapy in the published manuscript in the PAIN Journal. [1]

1 – Gilligan C, Volschenk W, Russo M, et al. An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial. Pain 2021; Article in Press. doi: 10.1097/j.pain.0000000000002258

73 %
reported substantial improvements in VAS and/or ODI, i.e., changes ≥ 50%, after one year
48 %
of patients on opioids at baseline voluntarily eliminated or reduced their intake after one year
Patient Testimonials

See the patients’ stories firsthand

ReActiv8 implanters and their clinical staff have seen patients’ lives change after treatment with ReActiv8. Watch their stories below 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. See paragraph below for US indication and product information.

Adults with Chronic Low Back Pain

Adults who have experienced mechanical CLBP on half of the days in the past year (or more frequently)

Inadequate relief with conventional treatments

Conventional medical management, including physical therapy and medication, have brought only temporary or inadequate relief

No prior surgeries

No clear indications for spine surgery and no prior lumbar spine surgery including fusions and/or other implanted devices

No radicular or neuropathic pain

Pain is primarily in the low back and is greater than pain in the leg (radicular or neuropathic pain). Neuropathic pain does not extend below the knee

Procedure Overview

Innovation leads to rehabilitation

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

FAQs

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 rehabilitative nature of the therapy, it may take some time for the pain relief and improvements in function to be experienced by the patient.

To assist in securing coverage from health insurance providers, we offer the ReActiv8 Support and Verification Program (R.S.V.P.) by partnering with experts specialized in working with health insurance companies and our physician partners. To learn more about enrollment for your clinic, contact us.

Become ReActiv8-certified today

Contact us to learn how ReActiv8 can fit into your practice.