Becker's Spine Review

59 Executive Briefing Sponsored by: F or years, many patients with chronic low back pain (CLBP) have been diagnosed with discogenic pain – pain originating from the discs located between the spinal vertebrae. But research over the past 30 years has shown that for many of these patients, their pain actually comes from their vertebral endplates – located on each side of the disc – and transmits through a nerve called the basivertebral nerve. This type of pain is now known as vertebrogenic pain. After more than a decade of clinical validation and procedural development, the Intracept® Procedure, developed by Relievant Medsystems, enables physicians to provide many patients with vertebrogenic pain with long-lasting relief. Becker's Spine Review recently spoke with two physicians who have significant experience with the Intracept Procedure: • Gregory A. Moore, MD, with Eugene, Ore.-based Pacific Sports and Spine; Dr. Moore is board certified in sports medicine, pain medicine and physical medicine and rehabilitation. • Ramana Naidu, MD, with California Orthopedics and Spine in Larkspur, CA; Dr. Naidu is a double board- certified anesthesiologist and pain physician who also serves as medical director of pain management at Greenbrae, Calif.-based MarinHealth Medical Center and medical director of Marin Specialty Surgery Center in San Rafael. These two physicians discussed their experience with the Intracept Procedure, how patients have responded, how they have positioned this procedure in their CLBP treatment pathway and how they see their Intracept program evolving in the future. A paradigm shift in the treatment of vertebrogenic pain Historically, patients suffering from CLBP have experienced gaps in care, explained Dr. Naidu. He noted a lack of condition-specific evidence for treatments, including medications, types of physical therapy or even epidural steroid injections. But an even more significant gap has been the lack of treatment options for patients experiencing vertebrogenic pain. For years, CLBP patients have journeyed from physician to physician seeking a durable pain solution, with little success, explained Dr. Naidu. Physicians often focused on a patient's disc when making treatment decisions, meaning that those with vertebrogenic pain, whose pain originates at the vertebral endplates, experienced sub- optimal outcomes. "Vertebrogenic pain was something that was not broadly recognized or understood until recently," said Dr. Moore, "It was also something that was considered untreatable." The Intracept Procedure has changed that. Having participated in Intracept's SMART trial starting in 2011, Dr. Moore is an early adopter. Based on his extensive experience, he terms the Intracept Procedure "a real paradigm shift." Dr. Naidu has been performing the Intracept Procedure since it became commercially available, finding the extensive evidence from the SMART trial (the first of two Level 1 Randomized Controlled Trials supporting the procedure) to be compelling. In thinking about the Intracept Procedure's role in CLBP patient care, Dr. Naidu draws a comparison to other pain management approaches in which treatment evolved from general injections to a focus on the nerve itself – which if blocked, can stop the transmission of pain signals altogether. To this end, as a result of the Intracept Procedure, Dr. Naidu said, "There's been a shift in how we think about treating this type of CLBP, and what outcomes we can expect for these patients – in both magnitude of relief, and durability of relief." Both doctors have similar approaches in identifying Intracept patients. They routinely review the patient's MRI – looking for Type 1 or Type 2 Modic changes – a biomarker that shows inflammation near the endplates, and which indicates the pain may be vertebrogenic. Both doctors also conduct a thorough physical examination to further gauge the patient's axial low back pain, and evaluate other potential pain generators, such as facets or sacroiliac joints. Historically, Dr. Moore would then proceed with a number of conservative therapies to try and relieve pain, including physical therapy, epidural injections, facet injections or radiofrequency ablation. The idea was to exhaust those possible conservative approaches first. Today, however, based on his Intracept-treated patient outcomes, Dr. Moore said, "I am quicker now to offer Intracept, as many of the patients I see with Modic changes already have not responded to at least 6 months of conservative care treatments, and the evidence indicates they can benefit long-term." Dr. Naidu's approach is similar. He stated, "Once I have a fairly good idea the patient has vertebrogenic pain, that they haven't responded to conservative care treatments after six months, and that Modic changes are present, I will offer the Intracept Procedure." Dr. Naidu continued, "Now that we have an effective therapy to treat vertebrogenic pain, I've been offering Intracept quite early on. For most of the patients I've seen for this procedure, I have offered it after the first time that I examine them." A new paradigm for treating chronic vertebrogenic low back pain

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