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Pain management physician Dr. Meredith Langhorst is recruiting patients for new clinical research study.
Approximately two thirds of adults struggle with low back pain at some point in their lives. For most people, back pain resolves within a few weeks or months. However, for 7 percent of sufferers, back pain becomes a chronic condition that can affect every aspect of daily life.
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.
If you struggle with chronic low back pain, and have not received lasting relief through medications and physical therapy, you may qualify for a new clinical research study being conducted by the physicians at OrthoIndy. The study is for ReActiv8®, a surgically implanted device designed to relieve chronic low back pain.
The initial qualification criteria for the study are those who:
- Are ages 22 to 75
- Have struggled with low back pain for at least three months
- Have not had lasting success with other treatments for your pain
- Have not had surgery on your lower back
- Able to attend regular follow-up visits at your study doctor’s office
How ReActiv8 works
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.
Frequently Asked Questions
What is the purpose of a clinical study?
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.
Are there any costs involved in the ReActiv8 Study?
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.
How long does the study last?
After receiving the ReActiv8 system, participants will be asked to return to their study doctor’s office about eight 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.
Who is sponsoring the study?
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.
I am interested in learning more. What’s the next step?
To see if you might qualify for the ReActiv8 Study, the next step is to contact the ReActiv8 Study Coordinator at OrthoIndy by calling 317.802.2851.
To schedule an appointment with Dr. Langhorst please call 317.802.2879 or learn more about non-surgical orthopedic care at OrthoIndy.
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