Back pain is the most common reason people go to their doctors. According to the National Institutes of Health, 80% of adults will experience low back pain at some time in their lives. Chronic low back pain, lasting 12 weeks or longer, is believed to affect nearly one-third of the U.S. population.
Now a minimally invasive, nerve ablating procedure that was recently cleared by the Food and Drug Administration, may give relief to some people with chronic low back pain.
“In 25 years of practicing orthopedics, this is the most important clinical study I’ve ever done, ” said spine expert Jeffrey Fischgrund, M.D., chairman, orthopedics, Beaumont Hospital, Royal Oak and principal investigator of the 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.”
For the study, research teams in the United States and Germany recruited 225 participants. One hundred fifty received the minimally invasive, ablation treatment and 75 received the placebo. The treatment used radio frequency energy to disable the nerve responsible for low back pain. Under local anesthesia, through a small opening in the patient’s back, an access tube was inserted into a vertebral body of the spine. Radio frequency energy was transmitted through the device, creating heat, which disabled the nerve. The access tube was then removed. The minimally invasive, implant-free procedure takes less than one hour.
“This is a new way to treat back pain. This type of treatment has never been done before, ” said Fischgrund. “It’s revolutionary. Compared to more traditional therapies; the odds of success are much greater.”
Patients eligible for this new procedure typically have been candidates for more invasive back surgeries and 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.
Relievant Medsystems Inc., a California-based medical device company, developed the nerve ablation procedure and technology.
Originally published in RY Ortho
by Biloine W. Young