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A minimally invasive nerve-ablating procedure, recently cleared by the FDA, 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, MD, chairman of orthopedics and orthopedic surgeon at Beaumont Hospital, Royal Oak (MI) and principal investigator of the FDA-approved trial of Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART). “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.”
Fischgrund helped design the research study. Research teams in the United States and Germany recruited 225 participants, with 150 receiving the minimally invasive ablation treatment and 75 receiving the placebo.
The outpatient 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 vertebral body. Radio frequency energy is transmitted through the device, which creates heat that disables the nerve. The access tube is 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 are candidates for more invasive back surgery or take strong pain medications, such as opioids. Those research participants who had the radiofrequency 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, a Redwood City, CA-based medical device company.
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 in their lives. Chronic low back pain, lasting 12 weeks or longer, affects nearly one-third of the nation’s population.
Executive Editor Joy Dickinson, Nurse Planner Kay Ball, Physician Reviewer Steven A. Gunderson, DO, and Consulting Editor Mark Mayo report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Stephen W. Earnhart discloses that he is a stockholder and on the board for One Medical Passport.