Mechanical chronic low back pain results from an injury or stress on the tissues surrounding the spine, including soft tissues, muscles, bones, and joints. Often times, this type of pain is due to impaired muscle control and neural inhibition of the multifidus, which is the largest stabilizing muscle in your back. When this neuromuscular inhibition occurs, there can be lack of spinal support, causing uncontrolled loading and pain. ReActiv8 overcomes neural inhibition and allows the body to regain control of the multifidus, providing functional lumbar stability and reducing mechanically-based pain.
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. Restoring the neuromuscular control of the multifidus muscle can stabilize the spine, thereby increasing function and decreasing pain.
ReActiv8 is designed to address the underlying cause of mechanical low back pain by helping patients restore neuromuscular control of the multifidus muscle. The device is implanted underneath the skin during a minimally-invasive outpatient procedure. A generator is connected to two electrical leads, which are positioned to stimulate the nerves that control your multifidus muscle. The patient controls the twice-daily therapy sessions, which can feel like a deep tissue massage.
ReActiv8 is for patients who have mechanical chronic low back pain, but have not found relief through medical management or physical therapy. Candidates should not have had (and are not in need of) spine surgery. Your doctor can help determine if ReActiv8 is right for you.
ReActiv8 is for mechanical chronic low back pain and is not indicated for neuropathic pain such as radiculopathy or complex regional pain syndrome.
ReActiv8 is not indicated for patients that have previously had reconstructive spine surgery in the lumbar region.
ReActiv8 is best suited for patients whose back pain is worse than their leg pain, assuming their leg pain does not extend below the knee.
Maintaining a healthy lifestyle is always important, however it is understandable that CLBP may prevent you from doing the amount of activity that you would like. Many patients in the ReActiv8 clinical trials were not able to exercise or do therapy due to back pain, but with ReActiv8 therapy, were able to gain function so they could start getting back in shape.
The mechanism that causes radiating leg pain is different from back pain, and ReActiv8 is not indicated to treat the former (leg pain).
Insurance FAQs
By enrolling in the RSVP program, you are able to increase your access to ReActiv8 through the submission of prior authorization and patient-based appeals facilitated by experts in this area.
Restorative treatments focus on improving function for patients by addressing the underlying cause. Palliative treatments focus on blocking pain through treatments like Spinal Cord Stimulation, oral medication, injections, or burning nerves (RFA, MBB).
No. The ReActiv8 system is designed to stimulate the nerves that control the muscles that stabilize the lumbar spine. This results in a comfortable therapy that cycles deep muscular contractions, with the goal of restoring your neuromotor control of the lumbar spine. In contrast, TENS units attempt to block painful signals by transmitting electrical signals through your skin. This results in a completely different sensation and does not address the root cause of mechanical back pain.
ReActiv8 is designed to retrain your body to use your deep stabilizing muscles correctly. Radiofrequency ablation (RFA) destroys the nerves that connect the brain to the parts of the spine and deep muscles with the purpose of keeping painful signals from reaching the brain. Unfortunately this also prevents the brain from communicating to these deep muscles to control spine stability. ReActiv8 is a restorative therapy that doesn’t destroy or alter any of the body’s natural anatomy.
ReActiv8 is the only neurostimulation therapy that works through a restorative mechanism, retraining your body to function naturally to support your spine. All other stimulators work by attempting to cover up the pain signals. Imaging
CT scans, fluoroscopy, ultrasound and X-Ray are all compatible with the ReActiv8 device. Special considerations must be made for MRI scans, however, and patients should review the ReActiv8 manual for more detailed guidance regarding MRIs. Long-term Clinical Outcomes
Patients that were on opioids at baseline: (1-year=31/65), (2-Year= 34/57), (3-Year= 36/51).
The IPG (which also contains the battery pack) is generally implanted in the upper part of the buttock, below the belt line and above the seat line, or in the flank between the hips and the ribs, to make it as comfortable as possible.
While patients will typically be able to feel where the IPG is located with their hands, after 60-90 days, the body will heal around the IPG to the point where it is less perceptible. The patient may be able to see the location of the incisions, but won’t typically be able to see the IPG outline through their skin (when standing naturally) or over clothing.
While everyone’s body is a little different, the nerve that is stimulated by the ReActiv8 leads is located in the same place in almost everyone. Your doctor will use x-ray images of your spine to obtain the best position of the leads to stimulate the nerve. The IPG (which also contains the battery pack) is generally implanted in the upper part of the buttock, below the belt line and above the seat line, or in the flank between the hips and the ribs, to make it as comfortable as possible. You should discuss the location of the IPG with your doctor before surgery.
Limit your activities to low or moderate levels during the first 4-6 weeks after implant. Light impact exercise such as walking or swimming is acceptable. Talk to your physician about what exercise may be right for you.
For the first 4-6 weeks, avoid lifting weights heavier than 10 pounds (e.g. a Gallon of milk).
Discuss with your physician ways to mitigate any pocket pain after the implant, as this should not persist for over a couple of weeks. Mild discomfort or awkward awareness of the pocket area typically subsides around 60-90 days.
Your wound will be checked around 4-7 days after surgery, where you will likely get your stitches removed. 10-14 days after surgery you will be instructed how to use your system and it will be activated. It is important to limit strenuous activity in the first 4-6 weeks to allow the system to heal.
You will require someone to take you home on the day of your implant, but you should be self-sufficient after the effects of
anaesthesia wear off.
The ReActiv8 device will not be turned on until the activation follow-up visit, about 10-14 days after surgery. At that time, the device stimulation will be programmed and individualized to patient therapy needs. The therapy starts with patients performing two, 30-minute sessions each day at convenient times. For most patients, this is typically once in the morning before getting out of bed and once in the evening when going to sleep or watching television.
Using a hand-held remote, the patient controls the twice-daily therapy sessions.
Most patients say the sessions feel like a pleasant series of deep muscle contractions, like flexing a muscle in an arm or leg, but in the lower back region. The system is programmed to be as comfortable as possible, so that it is easy and even enjoyable to perform the daily therapy sessions
The therapy sessions are twice daily for 30 minutes each. The device has a timer on it and does not allow stimulation for more than 60 minutes per day.
The stomach is the most preferable position because it puts the least amount of pressure on the leads. However, the goal is for you to use the device as much as possible in the first year to achieve the best results. Talk to your Mainstay representative about programming the device in your preferred position to get the most out of your therapy.
It is preferred to perform sessions while laying down to allow your muscles to be fully relaxed. Some recliner chairs or other situations may be acceptable if your muscles can be fully relaxed for the duration of the therapy session.
Changing position may alter the distance between your leads and the stimulated nerves, causing a slight increase or decrease in stimulation and a different sensation. Talk to your therapy specialist about the best positions to perform your therapy.
It is important to perform as many of your prescribed sessions as you can in the first 6-9 months of therapy, however missing a session periodically will not alter your outcomes as long as you are using the majority of your sessions.
The lockout period is to allow your muscles to rest and prevent overuse of stimulation. The system locks out for 2 hours after the first 30 min session, and for the rest of the day after the second session.
Yes, sometimes one side requires more energy output to correctly stimulate the nerve, and it takes longer to comfortably ramp this energy up to the programmed level. This can end up taking longer than the other side and therefore feel different.
Talk to your therapy specialist about the best position for stimulation. Performing sessions on your stomach or your back tend to give more even stimulation, but if you need to do sessions on your side your system can be programmed to give equal stimulation for a constantly used position.
The activator does not have the ability to pause a session. You can stop the session and start a new one at any time. The new session will run for a full 30 min unless you manually stop it.
Soft cloth lightly dampened with warm water.
The ReActiv8 system is tested to have enough battery life to last a minimum of 5 year with continuous use (two 30-minute session per day). However, in practice, ReActiv8 systems have shown to last much longer. If the batter ever does need replacement, a straightforward procedure to switch out the batter can be performed without having to replace the implanted leads.
No, the battery is primary cell and does not need to be charged.
The ReActiv8 follow-up schedule is tailored to customize the therapy to the patient’s body as it begins to restore control over the supporting muscles of the spine. It is an opportunity to gauge progress and celebrate the journey toward improved functionality and reduced pain. After the activation appointment, further follow-ups at 1, 3, and 6 months (or as needed) will be performed to tune your programming as the patient’s body heals and begins to restore proprioception and spinal stability
Quality of life has been measured in multiple studies and shows dramatic improvements out to 3 years.
The procedure is entirely reversible and the device can be removed by your physician.
A small percentage have elected to remove their device due to the resolution of symptoms after a few years of therapy.
Implant 1 Month Follow-Up
System Activation
(10-14 days) 3 Month Follow-Up
Yearly Follow-Up
(If needed)
6 Month Follow-Up
Living with ReActiv8
Yes, you can walk through metal detectors or screening devices with an implanted neurostimulator. Do not linger inside, and try not to touch the sides of the screening device. Tell the security personnel that you have a “pacemaker for pain” and show your ReActiv8 Patient Identification Card. You may also request a hand search. If the search involves a hand-held security wand, ask them not to hold the wand near your neurostimulator any longer than needed.
Yes, assuming that your doctor has cleared your incision as fully healed.
The ReActiv8 system cannot be used with Diathermy. The ReActiv8 system has not been tested with other active devices and you should consult with your physician.
It is suggested to wait 4-6 weeks before any heavy lifting or strenuous activity to ensure proper healing of your implanted system. Afterwards, refrain from activities that may induce excessive stress on your leads or IPG. For example, jiu jitsu, rowing, etc.
The impact of pregnancy on ReActiv8 therapy has not been studied, although there was incidence of this during the ReActiv8-B study. We will turn the device off for the duration of your pregnancy and then we will turn it back on at a later time.
It is preferred to take your activator while traveling so you can continue your therapy. However, small interruptions in the therapy will not disrupt the results in the long term. Be aware that the system does not update time zones, so your 2 sessions within a 24- hour period may be shifted. Discuss with a Mainstay representative about how your sessions may be affected.
The device is not designed to go further than 5 meters in depth.
While the device features protection from electromagnetic interference (EMI), some equipment can produce strong sources of EMI, e.g. transformers, electric welders etc. which may affect the device. Contact your physician if you have any questions. Clinical Studies and Patients Living with ReActiv8
Through the ReActiv8 Patient Ambassador Program, we offer the opportunity for patient-to-patient communications. You can sign up to talk to another patient by visiting https://patientpartner.com/mentor-match/reactiv8
