Intracept Intraosseous Nerve Ablation System Reduces Pain and Disability in Chronic Axial Low Back Pain

Michael H. Heggeness, MD, and Andrew I. Gitkind, MD, Comment

When axial chronic low back pain does not respond to conservative care, ablation of the intraosseous basivertebral nerve (BVN) that courses within the vertebral body may be an effective treatment for select patients, according to findings from a prospective, single-arm, multicenter study published in the February issue of The Spine Journal.

The findings demonstrate that there is “an effective way to treat many patients with disabling back pain, as in our small study, if patients meet the criteria stated in the report and have type 1 or type 2 Modic changes within the bone (indicating edema or inflammation),” explained senior author Michael H. Heggeness, MD, Program Director and Chair of Orthopaedics at the University of Kansas School of Medicine-Wichita. Stephan Becker, MD, and Alexander Hadjipavlou, MD, coauthored the study.

muscular man's back shows spine-related pain“Discogenic axial chronic low back pain is one of the most common causes of pain and disability in our country today” “Discogenic axial chronic low back pain is one of the most common causes of pain and disability in our country today, and one for which we have little to no evidence-based treatments for,” commented Andrew I. Gitkind, MD, Co-Director, Montefiore Spine Center, and Associate Director, Multidisciplinary Pain Program at Montefiore, Bronx, NY.

“As a result, this condition is not only one of the most common causes of doctor visits, it also is one of the most common causes of time lost from work,” Dr. Gitkind told SpineUniverse. “Should the preliminary findings described in this article prove true, and this procedure can successfully control back pain secondary to degenerative disc disease, this would be a huge step forward in the treatment of this wide-spread epidemic.”

Building on Previous Research
Previous research by Dr. Heggeness and colleagues demonstrated the presence of intraosseous BVNs and that these nerves contain pain-associated neurotransmitters. The investigators also found that “the bone deforms almost as much as the disc when the spine is loaded,” as a result of disc degeneration, Dr. Heggeness said.  

In the present study, 16 patients (mean age, 48 years) with isolated axial low back pain (L3-S1) lasting at least 6 months underwent ablation of intraosseous BVN within vertebrae adjacent to degenerated discs. Ablation was performed using radiofrequency energy delivered by the FDA-approved Intracept Intraosseous Nerve Ablation System. All patients were nonresponsive to at least 3 months of conservative care and had evidence of type 1 or 2 Modic changes.

Patients with prior spinal surgery, spondylolisthesis, scoliosis, history of spinal infection, radicular symptoms, or prior spinal malignancy were not eligible for the trial.

The Intracept System is FDA-approved for treatment of chronic low back pain, and is being prepared for launch in the United States. The study was funded by the device’s manufacturer, Relievant Medsystems.

Disability Scores Decreased Significantly Following BVN Ablation
Statistically significant improvement in the Oswestry Disability Index (ODI) was found at 6 weeks and was sustained throughout the 1-year followup study (P<0.001 at all time points). The mean ODI decreased from 52 to 23 points from baseline to 3-month follow-up. At 1 year, mean scores were improved by more than 28 points from baseline.

In addition, pain levels decreased significantly from a mean visual analog scale (VAS) score of 61 at baseline to 38 and 45 at 6 weeks and 3 months, respectively (P<0.05). The mean Short Form-36 physical component summary score increased from 34.5 to 41.7 between baseline and 3-month follow-up (P=0.03).

The learning curve for using BVN ablation is “not steep at all with the new probes,” according to Dr. Heggeness.

“In my opinion, if proven to be successful, this treatment would be most appropriate for use in patients diagnosed with chronic axial back pain related to degenerative spine disease who have been refractory to previous conservative treatment,” commented Dr. Gitkind. “Given the findings of this small preliminary study, further research on this treatment modality should be conducted and examined within the spine care community.  Studies, including larger sample sizes, a control group, and including longer term follow-up would be helpful in determining the long-term viability of this treatment,” Dr. Gitkind said.

Randomized Control Data Presented at NASS 2016
A prospective randomized clinical trial confirming the efficacy BVN ablation using the Intracept System was recently presented by Fishgrund et al at the 2016 Annual Meeting of the North American Spine Society. The study, which involved 225 patients with axial chronic low back pain, showed significantly greater improvement in ODI score in the ablation arm (n=147) compared to the sham arm (n=78; P=0.019).

In addition, 75.6% of patients treated with the Intracept System had a ≥10-point improvement in pain and associated disability at 3-month followup.

“It is important to remember that a reliably successful treatment for discogenic axial low back pain has yet to have been identified,” Dr. Gitkind noted. “While there have been many new treatments proposed over the past 20 or so years, which have shown great success in early trials, most of these have not been proven to be successful in the long run. While new treatment approaches are exciting and always continue to provide optimism that we will find the ‘gold standard’ treatment, we must approach them with caution and due diligence,” Dr. Gitkind concluded.

Disclosures
Michael H. Heggeness, MD is a stockholder of Relievant Medsystems.
Andrew I. Gitkind, MD has no relevant disclosures.

Updated on: 02/08/18
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