ReActiv8 restorative neurostimulation

What it treats, and what the evaluation decides

ReActiv8 treats long-lasting low back pain linked to poor control of the multifidus, a deep muscle that stabilizes the spine. It stimulates the nerve to that muscle on both sides, causing contractions that aim to restore the muscle’s control. It hasn’t been studied in people whose leg pain is worse than their back pain or who have nerve pain below the knee.

The evaluation decides whether your back pain fits that pattern: an exam and imaging or physical testing showing multifidus dysfunction.

Who may be considered, and what can rule it out

The FDA approved ReActiv8 for adults with intractable chronic low back pain associated with multifidus muscle dysfunction, shown by imaging or physiological testing, who have not improved with therapy including pain medicines and physical therapy and who are not candidates for spine surgery.

• No MRI after implant. The labeling says MRI must not be used with this system, so tell your physician if you’re likely to need MRI scans in future.
• No diathermy (deep-heat treatments such as short-wave, microwave or therapeutic ultrasound diathermy).
• It isn’t suitable if you can’t operate the system or aren’t suitable for the implant surgery. Safety hasn’t been established in pregnancy, under age 22 or with a body mass index above 35.

Alternatives to discuss

Other care we offer that your physician may compare with ReActiv8 includes continued physical therapy focused on spinal stability, medicine changes, radiofrequency ablation when facet joints are the source, basivertebral nerve ablation for pain from the vertebral endplates, and spinal cord stimulation, which works differently and is used more for nerve pain.

What to bring to your evaluation

• Recent lumbar MRI or other imaging reports
• Physical therapy records: how long, what was done, and how it went
• A list of other treatments you’ve tried, and your medicine list
• A note of any planned or likely MRI scans
• Insurance card, and a claim number for a car accident or work injury

What happens, step by step

1. EvaluationExam and imaging or testing to see whether multifidus dysfunction is the likely driver of your pain. Unlike spinal cord stimulation, the device’s labeling doesn’t describe a trial period, so this step decides candidacy.
2. ImplantUnder general anesthesia, leads are guided with X-ray to the nerve on each side near the L3 vertebra, and the small device is placed in a pocket under the skin. Most people go home the same day.
3. Turning it onThe device isn’t switched on right away. It is activated at a follow-up visit.
4. Daily sessionsYou start stimulation sessions with a hand-held remote, usually twice a day, for example two 30-minute sessions.
5. Follow-upCheck-ins to review how you’re using it and how your pain and function are changing.

Preparation and practical limits

• Recovery from the surgery usually takes four to six weeks. Your surgeon tells you which activities are safe and when to return to work.
• Avoid excessive twisting or stretching for the first few weeks, and sudden, excessive or repetitive bending, twisting, bouncing or stretching at any time.
• Mild soreness where the device sits can last up to about three months.
• Ask how to handle blood thinners before surgery; don’t stop one without the prescribing doctor’s advice.

Risks, and why results vary

Risks include infection, lead movement, nerve irritation, pain, unwanted stimulation sensations, device problems and continued back pain. Several of these, such as infection or lead movement, usually need another operation to fix or remove the device.

Results vary from person to person.

If it doesn’t help enough

Because the decision is made at the evaluation rather than after a trial, talk with your physician early if you’re not improving as expected. They can check how you’re using the device and its settings, and go over the other options with you, including whether the system should be removed.

Cost and coverage

When it’s medically necessary, this procedure is usually billed to health insurance, Michigan auto no-fault or workers’ comp, and most plans need prior authorization. Insurers often have their own requirements before approving an implant. Our team checks your benefits and the authorization before anything is scheduled and tells you about any cost you’re likely to owe. The surgery center or hospital may bill separately from the physician; ask us which charges to expect. See who usually pays · Ask us to check your coverage

Related reading

• Multifidus dysfunction
• Low back pain
• Neuromodulation

Where to get care at Specialty Medical Center

Evaluations are with our interventional pain physicians in Dearborn and Sterling Heights. Part of Neuromodulation.

Eduardo José Otero Loperena, MDInterventional pain medicineMohamed Osman, MDPain managementAaron Greenberg, DOPhysical medicine and rehabilitation

Who performs procedures, and where:

• Dr. Eduardo José Otero: Universal Care Surgery Center
• Dr. Mohamed Osman and Dr. Aaron Greenberg: Universal Care Surgery Center and Advanced Surgery Center
• Dr. Roy Torcuator: Advanced Surgery Center and Garden City Hospital

Office injections are done in our offices. Your physician confirms who performs your procedure, and where, at your consultation.

Sources

• FDA premarket approval P190021: ReActiv8 Implantable Neurostimulation System (approved June 16, 2020)
• FDA: ReActiv8 labeling (P190021)
• Cleveland Clinic: ReActiv8 procedure

This page gives general information. Your physician will explain whether a treatment fits you, its risks and the alternatives.