Back pain is a real problem. 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 affects nearly one-third of Americans and is the most common reason people go to the doctor’s office.
Laura Donlon, 48, of Monroe, Michigan 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.
Treatments for low back pain range from noninvasive to invasive: physical therapy, pain medications to major surgery, such as spinal fusion. But Laura wanted something non-invasive, but effective. She turned to a recently approved nerve ablating procedure with this hopes it might her relief.
“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 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.”
Dr. Fischgrund helped design the research study, which included teams from the U.S. and Germany. The study included 225 participants, with 150 receiving the ablation treatment and 75 receiving the placebo.
Donlon enrolled in the study and had the outpatient spine procedure, but did not know if she received the minimally invasive trial procedure or a placebo. So, she had to guess based upon 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.
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 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.”
The nerve ablation procedure and technology was developed by Relievant Medsystems Inc., a California-based medical device company.
Nineteen months after Donlon’s 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.”