New low back pain procedure gets FDA approval

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New low back pain procedure gets FDA approval

There is a hope on the very horizon for people suffering from low back pain. A relatively new procedure known as minimally invasive nerve-ablating procedure seems to be effective in treating some forms of back pain and may offer a new treatment option.

According to 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), "In 25 years of practicing orthopedics, this is the most important clinical study I’ve ever done." He added, “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.”

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 FDA, may give some people with chronic low back pain a new treatment option. 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.

A minimally invasive procedure is usually performed with local anesthetic and mild sedation. The procedure involves using radio frequency energy to target the nerve causing the low back pain. Surgeons insert an access tube through a small cut in a patient's back, toward a vertebral body. Then, they transmit radiofrequency energy via the device, creating heat, which disables the nerve. The access tube is then removed. Surgeons perform the procedure in less than one hour. The researchers found those patients receiving the nerve ablating procedure reported significant improvement in their back pain within two weeks of surgery.

The nerve ablation procedure and technology was developed by Relievant Medsystems, California-based medical device company. It's the most common reason people go to their doctors – back pain. It is the top cause of disability worldwide. According to the National Institutes of Health, 80% of adults will experience low back pain some time in their lives. In fact, chronic low back pain, lasts more than 12 weeks and may persist for years, affects nearly one-third of the population.

Exploratory, FDA, Low back pain, Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART)
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