Laura Donlon. Image courtesy of Beaumont Health.
According to the National Institutes of Health, 80 percent of adults will experience low back pain some time in their lives. In fact, chronic low back pain, lasting 12 weeks or longer, affects nearly one-third of the nation’s population. And it’s a common complaint for those with lower-limb amputations.
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 physical therapy and pain medications to major surgery, such as spinal fusion. Now a minimally invasive nerve ablating procedure, recently cleared by the Food and Drug Administration (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, 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.”
For the study, research teams recruited 225 participants, with 150 receiving the minimally invasive ablation treatment and 75 receiving the placebo.
Donlon enrolled in the study. In December 2014, she had what researchers later confirmed at the completion of the blind trial to be the nerve ablation procedure.
“After the procedure, I went home and within 24 hours I could touch my toes,” said Donlon, a running enthusiast and marathon competitor. “Within 48 hours, I was back to work.”
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.
“It’s revolutionary, compared to more traditional therapies,” Fischgrund said. “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 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.
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.”
This article was adapted from information provided by Beaumont Health.