Abstract
BACKGROUND: Strong innervation of the vertebral endplates by the basivertebral nerve makes it an ideal target for ablation in the treatment of vertebrogenic low back pain with Modic changes. This data represents the clinical outcomes for 16 consecutively treated patients in a community practice setting. METHODS: Basivertebral nerve ablations were performed on 16 consecutive patients by a single surgeon (WS) utilizing the INTRACEPT® device (Relievant Medsystems, Inc.). Evaluations were performed at baseline, 1 month, 3 months, and 6 months. The Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and SF-36 were recorded in Medrio electronic data capture software. All patients (n = 16) completed the baseline, 1 month, 3 months, and 6 months follow-up. RESULTS: The ODI, VAS, and SF-36 Pain Component Summary showed statistically significant improvements above minimal clinically important differences at 1 month, 3 months, and 6 months (all p values <0.05). Change in ODI pain impact declined 13.1 points [95% CI: 0.01,27.2] at one month from baseline, 16.5 points [95% CI: 2.5,30.6] at three months from baseline, and 21.1 points [95% CI: 7.0,35.2] six-months from baseline. SF-36 Mental Component Summary also showed some improvements, but with significance only at 3 months (p = 0.0091). CONCLUSIONS: Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of chronic low back pain that can be successfully implemented in a community practice setting. To our knowledge, this is the first independently funded US study on basivertebral nerve ablation.