FDA Approves New Minimally Invasive Procedure for Back Pain

Back pain is the most common reason for many to visit the doctor. Nearly 80 percent of the adults experience low back pain at some point in their lives. Chronic low back pain lasts for 12 weeks or longer, according to the National Institutes of Health. Laura Donlon, 48, of Monroe had been dealing with low back pain for five years before she found out about a back pain study at Beaumont Hospital in Royal Oak, Michigan. The flight attendant says her pain was unbearable at times, especially when sitting. Seeking relief from her pain, caused by a degenerative disc, she contacted the orthopedic research team at Beaumont for details.

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, 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."

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.

Donlon was told she met the trial criteria and enrolled in the study. In December 2014, she had an outpatient spine procedure by Beaumont physicians. Because she did not know if she received the minimally invasive trial procedure or a placebo, she had to guess based on results.

"After the procedure, I went home and within 24 hours I could touch my toes," said Donlon, a running enthusiast and marathon competitor. "That's when I figured I had the study procedure. Within 48 hours, I was back to work." One year later, the research team confirmed what she suspected; she had undergone the nerve ablation treatment.

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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.

"This is a new way to treat back pain. This type of treatment has never been done before," said Dr. Fischgrund. "It''s revolutionary, compared to more traditional therapies; the odds of success are much greater."

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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.

Nineteen months after Donlon's minimally invasive nerve ablation treatment, she said, "Today, I have no back issues. I'm pain free. In fact, since my procedure, the pain has not recurred. I'm extremely grateful for the care and treatment I've received through my participation in the lower back pain study."



Source-Newswise