Chronic
LOW BACK PAIN?

See if the ReActiv8® Clinical Study is right for you

 

If you struggle with chronic low back pain, and have not received lasting relief through medications and physical therapy, you may be interested in a new clinical research study. The study is for ReActiv8® – an investigational device that is placed through a minimally-invasive reversible surgical procedure, and is designed to relieve chronic low back pain.

About the ReActiv8® Study

Chronic Low Back Pain

In most cases, low back pain starts as a simple strain or sprain in one of the spine joints. To avoid pain, the brain automatically tries to limit muscle activation around the painful joint. However, reduced muscle activation also worsens stability of the lower back. This allows the spine segments to move more easily into painful positions. If not resolved, this can lead to an ongoing cycle of low back pain and muscle weakening. Many studies show that reactivation of these muscles is an important step in breaking the cycle of chronic low back pain.


What is ReActiv8®?

ReActiv8® is a surgically-implanted device that uses mild electrical stimulation to activate the key stabilizing muscles of the lower back. Similar to exercise programs used to restore muscle control, ReActiv8 stimulation is delivered twice a day for about 30 minutes. You control when to start and stop each stimulation session via a handheld wireless remote control. Over time, ReActiv8 is designed to help your body regain control over the muscles that provide lower back stability, which may help relieve chronic low back pain.

ReActiv8 is placed through a minimally-invasive, reversible surgical procedure. Your doctor will make a small incision to place thin wires, called leads, on either side of your spine. The leads connect to a small pulse generator (about the size of a matchbox). The pulse generator is implanted just below the skin, normally in the upper buttock.

The ReActiv8 Clinical Study

Right now, doctors at select centers throughout the US are accepting participants for a new clinical study to evaluate ReActiv8 for the treatment of chronic low back pain. Participants in the study will receive the ReActiv8 system and all study-related care at no cost.
Frequent Questions
Clinical studies (also called clinical trials) are used to learn about the safety and effectiveness of possible new medications, medical devices, and medical procedures. Although there are many types of clinical trials, all must conform to strict rules set by the U.S. Food and Drug Administration (FDA). These rules help protect the rights and safety of those who volunteer to take part in clinical trials.
If you choose to join the ReActiv8 Study, you will receive all study-related care at no cost. This includes the ReActiv8 system and procedure, as well as any visits to your study doctor’s office. You may also be compensated for travel expenses to attend study visits.
After receiving the ReActiv8 system, participants will be asked to return to their study doctor’s office about 8 times over a 1-year period, and then once a year thereafter (up to a maximum of 6 years). This allows your study doctor to closely monitor your individual results and experiences.
The study is being sponsored by MML US, Inc. (www.mainstay-medical.com), a global medical device company with offices in the US, Australia, and Ireland.
To see if you might qualify for the ReActiv8 Study, and to be referred to a study center in your area, the next step is taking the pre-screening questionnaire. Please click here to get started

See If You Qualify

To see if you might qualify for the ReActiv8 Clinical Study, and to be referred to a study center in your area to learn more, please take the questionnaire below. If you prefer to take the questionnaire over the phone, please call 1-888-978-8391.