FDA approves minimally invasive procedure for low back pain
In fact, chronic low back pain, lasting 12 weeks or longer, affects nearly one-third of the nation's population.
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, 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.
A spine expert and orthopedic surgeon, Dr. 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 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.
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, a California-based medical device company. ■