Michael Schaufele, a doctor with Marietta Pain Solutions Treatment Center at 400 Tower Road, between Church Street and Kennesaw Avenue, is enrolling local residents in a national clinical trial to test the ramifications of a new treatment option.
“Chronic low back pain can be debilitating for sufferers, significantly affecting their ability to participate in normal, everyday activities and impacting their overall quality of life,” said Schaufele, who is also an associate professor at the Emory Spine Center in Atlanta.
Treatments are limited to narcotic pain medicine that comes with risks of addiction or invasive surgical procedures that can result in permanent loss of flexibility, according to a report by Relievant Medsystems, a private medical device company that is spearheading the Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain Trial.
“A little-known nerve located within the bones of the vertebrae may be the underlying cause of their pain,” stated the Relievant Medsystems’ study.
Schaufele said the new medical concept around the SMART Trial is the Intracept Basivertebral Nerve Ablation Procedure that attacks a specific area’s nerve supply.
Surgeons make a small incision in the lower back to navigate to the basivertebral nerve. A specialized probe then emits heat via radio frequency to disable the nerve from transmitting pain signals.
Schaufele said the outpatient procedure takes one hour to complete, and a patient should have a full recovery within a few days to a few weeks.
“Within a month patients should see if they benefit from the procedure,” Schaufele said.
He said the idea is to only require one treatment for the rest of a person’s life.
The intracept procedure was developed based on research conducted in 2007 by Michael Heggeness, a doctor formerly with the Baylor College of Medicine.
The small initial pilot study reported immediate relief to patients, so the next step is to evaluate the safety and rate of effectiveness of the technique, Schaufele said.
The nationwide clinical trial will include 200 patients from 15 different medical centers. Schaufele said he started vetting patients this spring and has enrolled 10 people, with ten spots left.
Out of 1,000 people that apply, only ten to 20 may qualify for the clinical trial, but if the treatment is approved, 5 to 10 percent of back pain sufferers could benefit, Schaufele said.
It will take a year to analyze the data and publish results, but Schaufele said he expects a decision from the Food and Drug Administration within two to three years.
Because the SMART Trial is a randomized blind study, some subjects will be given a placebo treatment. All participants will visit a doctor five times over a 12 month period to answer questions about symptoms and overall health, as well as complete several tests to monitor their condition.
The health care related to the trial will be free, and anyone that was given the placebo will have the option to get the real procedure at the end of the study.
Schaufele said because of the recent bad economy, investors in the health field have not been willing to front money to seek out new medical discoveries, but with the market improving, there is more willingness to invest in finding pain solutions.
“I hope this is just one of the innovations we will see in the future that will accomplish the goal of treatment,” Schaufele said.
To qualify for the Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART) Trial, a patient must be 25 to 70 years old, have at least six months of chronic axial lumbar pain that has not responded to other treatments, with no previous surgeries on the lumbar spine.
To find out more, visit www.smartclinicalstudy.com or call 1 (888) 978-8396.