INDIANAPOLIS — In an effort to provide relief to patients suffering from chronic back pain, officials with the Indiana Spine Group recently announced that they’ve been participating in the Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART) Trial.
According to a press release from the Indiana Spine Group, the Institute of Medicine tabbed low back pain as the most prevalent and expensive non-lethal medical condition in the United States, which affects about 100 million adults. Those affected by back pain is more than the total affected by heart disease, cancer, and diabetes combined.
Per the same press release, about 12 million new patients look for treatment for back pain and nearly 2 million of those patients fail to respond to conservative therapies.
According to Dr. Kevin Macadaeg, vice president and founder of the Indiana Spine Group, the SMART trial may provide relief and remove the need for escalating use of pain medications, invasive surgery, or continued suffering.
“The holy grail of treating back pain, or treating disk related pain, is to come up with a way to get rid of the pain that is minimally invasive if a person has failed all the efforts of conservative measures,” Macadaeg said. “It doesn’t matter whether a person has been to physical therapy, or exercise, or medications, a chiropractor, acupuncture, or even epidural steroid injections. All those things are meant to make the back feel better, but none of those things actually touch the disk. The only other traditional method of trying to get rid of the pain is to take the disk out and fuse the spine. This is the holy grail of trying to treat a disk, which is a directed treatment to the disk, yet not changing the structure to the spine.”
Macadaeg likened the trial to a root canal.
“To say it in a nutshell, it’s almost as if we’re doing a root canal to a disk,” he said. “We’re taking away the nerve supply to a disk that is painful to basically numb the disk up so that it hopefully resolves a person’s back pain just through a needle.”
Macadaeg said by using an MRI, doctors can find what disk is causing the pain.
“We’re able to look at an MRI and correlate a disk that is suspicious looking as a source of the pain and just match it up where the person hurts,” he said. “If the history and physical (aspect) seem to match up, we’re able to place a needle into the spine where the nerve supply goes to the disk. We just cauterize the nerve supply away from the disk. By far the most common reason why a person does have back pain is due to a disk that hurts.”
According to the Indiana Spine Group, to qualify, one must be a male or female between the age of 25 and 70, have at least six months of chronic axial lumbar pain, have failed to respond to at least six months of non-operative conservative management, and have no previous surgery performed on the lumbar spine.
Macadaeg said the trial has been going on for about a year and a half around the country and world, but the Indiana Spine Group has treated the most patients.
“We’re the No. 1 site,” he said. “There are multiple sites around the country and outside of the country, and we’re the No. 1 site as far as the number of patients that have been treated.”
Macadaeg said one of the best aspects of the trial is that if it doesn’t work on a patient it doesn’t leave them worse off.
“What’s great about it is, it’s one of those things that if it works, it works, if it doesn’t work the person, we believe, would be no worse off,” he said. “In other words, we’re not changing the structure to the spine, and that’s a big deal. Disk pain is by far the most common reason why a person has back pain and yet we don’t have a great answer for it. If we can get something like this to work, it would be a huge deal.”
According to the Indiana Spine Group, the SMART study, sponsored by Relievant Medsystems, is a prospective, randomized, double-blind, sham-controlled clinical trial evaluating the safety and effectiveness of the Intracept procedure in reducing pain in patients with chronic axial low back pain.
For more information on the SMART study, visit the website at www.smartclinicalstudy.com or call 1-888-978-8396.