Participate in Clinical Trial for Patients With Lower Back Pain

SpineCare Medical Group announced it is participating in a pivotal clinical study aimed at establishing, for the first time, if the Intracept® Basivertebral Nerve Ablation Procedure, a minimally invasive radio frequency ablation therapy can offer hope and relief for patients suffering from chronic axial low back pain. According to the Institute of Medicine, low back pain is the most prevalent and expensive non-lethal medical condition in the United States affecting about 100 million American adults—more than the total affected by heart disease, cancer and diabetes combined. 

Every year, approximately 12 million new patients seek treatment for back pain. Unfortunately, nearly 2 million of these patients fail to respond to conservative therapies; these patients have few options and often face escalating use of pain medications, invasive surgery or continued suffering. What many people suffering from chronic back pain may not know is that the little-known basivertebral nerve, located within the bones of the vertebrae, may be the underlying cause of their pain. Now, researchers have begun to look at this nerve as a possible leading contributor to back-related pain and explore how disabling it may offer patients a new pain-reducing treatment option.  

The Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART) Trial, study is taking a closer look at the basivertebral nerve and the potential benefits of treating pain that may be caused by this nerve. The Intracept procedure, based on the research of Michael Heggeness, MD, PhD, while at the Baylor College of Medicine, is a simple, minimally invasive therapy that uses radiofrequency energy delivered through a small access tube into the vertebral body to ablate (destroy with heat) the basiverterbal nerve. Once ablated, this nerve is no longer able to transmit pain signals. The Intracept procedure, which requires no implant and is typically completed in about one hour, may be a viable treatment alternative for the millions of patients for whom treatment options are often limited.  
        
“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. For the millions of patients who don’t respond to conventional treatment, remaining options are limited,” said David M. Jackson, M.D., at SpineCare Medical Group. “The discovery of the basiverterbal nerve’s role in chronic axial low back pain and the ability for radio frequency ablation therapy to render the nerve ineffective may represent a significant advancement in the evolution of minimally invasive treatment. The SpineCare Medical Group was selected to participate in the SMART study because of our extensive experience treating patients who suffer from chronic low back pain and we look forward to contributing to this important research.”

The SMART study, sponsored by Relievant Medsystems, is a landmark 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. Enrolling 200 patients at 15 leading medical centers across the U.S., the study’s primary endpoint is the evaluation of patient improvement in Oswestry Disability Index (ODI) at three months compared to baseline between treatment and sham populations. In addition, change in multiple patient-reported outcomes from baseline will be assessed at three, six, and twelve months, as well as safety evaluations at all time points. Importantly, patients and clinicians who perform the follow-up evaluations are blinded to the randomization of the sham vs. experimental procedure.

To qualify, patients must meet several eligibility criteria, including: 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. 

Individuals interested in additional information on the SMART study are encouraged to visitwww.smartclinicalstudy.com, or call 1-888-978-8396.