A new paradigm for treating chronic vertebrogenic low back pain

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For 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."

Patients are responding well to the Intracept Procedure
Overall, Dr. Moore’s patients have responded very well to Intracept. He has had several patients who were "home runs," experiencing 90 percent to 99 percent relief within one to three weeks post-treatment. His patients, many who are in their 40s and 50s, have remarkable stories of returning to physical activities like golfing or biking that they hadn’t enjoyed in years following the procedure. "A majority of my patients experience a 50-75 percent improvement in their pain and function within a few months," he said, "and it’s these compelling anecdotes from patients, returning to their desired activities, that continue to push us to offer this therapy."

Dr. Naidu’s outcomes have mirrored those from the SMART RCT. He estimates that the average pain reduction experienced by his patients has been in the 60 to 70 percent range, and he, too, has been pleased to see several high responders reporting 90 to 100 percent relief of their pain.

Particularly interesting to Dr. Naidu has been the patient improvement over time. "Unlike many other procedures we perform, where you get a great result early on in the first few weeks and then you see them six or 12 months later and the pain starts to return, you actually see the opposite with this procedure. You may see gradual results early on, like at the two- or four-week mark, but then you see the patient at the six-month and 12-month mark and they’re better than they were at those earlier time points."

"It is interesting," Dr. Naidu continued, "that when the five- year data came out from the SMART Trial, it showed the same sort of result — that five-year outcomes were even better than what we saw with the three month and two-year outcomes. As a matter of fact, the incremental improvements were statistically significant from 12 and 24 months to 5 years."

The Intracept Procedure as a driver of growth
"As physicians, we are focused on helping patients in any way possible. I see the Intracept Procedure being a significant part of our practice’s CLBP care continuum," Dr. Naidu said. To help identify and treat patients, Dr. Naidu has spent time educating the spine surgeons in his practice about the benefits of the Intracept Procedure and about which patients are the most appropriate candidates.

Dr. Moore sees continued Intracept adoption as physicians become more familiar with the procedure. He is working to get the other physicians in his practice trained on this procedure and is beginning to integrate it in his
treatment plan as a first-line therapy for some patients with vertebrogenic CLBP. He is also committed to educating other providers in his community about this innovative procedure. He explained, "I’m trying to get the word out so that we can increase community awareness, and continue to expand our Intracept program, providing this patient population with few options an effective treatment they historically haven’t had."

Offering this innovative procedure is helping separate Dr. Moore’s practice from others in the community, he notes. Dr. Naidu concurred and noted, "This procedure has actually opened up the doors to more interventions in my practices, which has helped me provide more treatment options for patients." 

Conclusion
Patients with chronic low back pain have historically cycled through treatments, searching for both sufficient and long-lasting relief. Supported by two Level I RCTs and recent 5-year data, the Intracept Procedure from Relievant Medsystems has significantly improved the lives of many patients with CLBP who have failed conservative treatments. The procedure has filled a gap in the CLBP care pathway, allowing patients with vertebrogenic pain to return to the physical activities they enjoyed years ago.

Both Dr. Moore and Dr. Naidu have incorporated Intracept into their care pathway – actively screening patients for Modic changes and endplate damage, and talking with appropriate patients about how Intracept may benefit them. They believe it is important for physicians providing care for CLBP patients to be familiar with the Intracept Procedure, to understand which patients may be appropriate candidates for the therapy, and to incorporate the procedure into their CLBP practice. As both physicians confirmed, Intracept is a paradigm shift in the treatment of vertebrogenic CLBP, bringing long-lasting pain relief to a historically challenging segment of the chronic pain population.

This article was sponsored by Relievant Medsystems.

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