Beaumont Health First and Only Michigan Health System to Test Chronic Low Back Pain Device

Newswise — About two-thirds of U.S. adults will struggle with low back pain during their lifetime. It is the most common cause of job-related disability and a leading cause of missed work days. Medication and physical therapy typically relieve some of the symptoms, but sometimes patients remain in pain.

 

Beaumont Health is leading the research of a new approach to treat low back pain, the ReActiv8 implantable stimulation system. The ReActiv8-B Clinical Study is evaluating the safety and effectiveness of ReActiv8 for the treatment of adults with chronic low back pain and no prior spine surgery. The device may be used in conjunction with medication patients are currently taking. 

 

ReActiv8 is a surgically-implanted device that delivers mild electrical stimulation to nerves in key lower back muscles. Unlike other nerve treatments, ReActiv8 does not mask a patient’s pain. It aims to help patients regain control of the muscles in their back. To qualify for the study, patients must be between the ages of 22 and 75, have experienced low back pain for at least three months and have not had lasting success with other pain treatments including medications and physical therapy.

 

“Beaumont currently offers innovative procedures to treat low back pain, but we think it’s important to bring new clinical trials to our patients, too. Stabilizing muscles can reduce back pain. While physical therapy and medications work for most, there’s a significant patient population who continue to struggle with chronic low back pain,” said Jeff Fischgrund, M.D., Beaumont chair of Orthopedics. “We are looking for patients who have tried everything else, but still have not found relief. We are looking for patients who are not willing to settle with chronic 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 tries to limit muscle activity around the painful joints. However, less activity can worsen the stability of the lower back and lead to additional back pain problems.

 

Previous studies have shown reactivating back muscles can help break the cycle of chronic low back pain.

 

 

Approximately 128 patients will be implanted with the device at sites in California, Colorado, Indiana, Kansas, Massachusetts, Michigan, North Carolina, Ohio, Rhode Island, South Carolina, and West Virginia. 

 

Study candidates may not have had spine surgery and may not currently have any other chronic pain conditions. Participants must be willing to undergo a surgical procedure and come in for follow-up visits. 

 

*The ReActiv8 Implantable Stimulation System is an investigational device and is limited by United States law to investigational use.