One of the most common reason people go to their doctors is back pain. According to the National Institutes of Health, 80 percent of adults will experience low back pain some time in their lives. In fact, chronic low back pain, lasting 12 weeks or longer, affects nearly one-third of the nation’s population. Needless to say, spine injury is a great portion of a workers’ compensation claim department inventory.
Treatments for low back pain range from noninvasive to invasive: physical therapy, pain medications to major surgery, such as spinal fusion. Now a minimally invasive, nerve ablating procedure, recently cleared by the Food and Drug Administration, may give some people with chronic low back pain a new treatment option.
“In 25 years of practicing orthopedics, this is the most important clinical study I’ve ever done,” said Jeffrey Fischgrund, M.D., chairman, Orthopedics, Beaumont Hospital, Royal Oak and principal investigator of the FDA-approved Relievant SMART trial. “The system is proven to be safe and effective in clinical trials. It is much less invasive than typical surgical procedures to treat low back pain.”
The treatment uses radio frequency energy to disable the targeted-nerve responsible for low back pain. Under local anesthesia with mild sedation, through a small opening in the patient’s back, an access tube is inserted into a specific bony structure of the spine, called a vertebral body. Radio frequency energy is transmitted through the device, creating heat, which disables the nerve. The access tube is then removed. The minimally invasive, implant-free procedure takes less than one hour.
The technology is indicated for treating one or more levels between L3 and S1 in people that have not responded to more common treatments for over six months. The main side effect of Radio Frequency Ablation (RFA) is some discomfort, including swelling and bruising at the site of the treatment, but this generally goes away after a few days. As with any medical procedure, RFA is not appropriate for everyone. For example, radiofrequency ablation is not recommended for people who have active infections or bleeding problems.
Patients eligible for this new procedure typically are candidates for more invasive back surgery or take strong pain medications, like opioids. Those research participants that had the radio frequency ablation procedure noticed significant improvement in their back pain within two weeks of surgery.
The nerve ablation procedure and technology was developed by Relievant Medsystems Inc., a California-based medical device company.