Ablation of the basivertebral nerve for treatment of back pain: a clinical study

BACKGROUND CONTENT: Lumbar axial back pain arising from degenerative disc disease continues to be a challenging clinical problem whether treated with nonsurgical management, local injection, or motion segment stabilization and fusion. PURPOSE: The purpose of this study was to determine the efficacy of intraosseous basivertebral nerve (BVN) ablation for the treatment of chronic lumbar back pain in a clinical setting. STUDY DESIGN: Patients meeting predefined inclusion or exclusion criteria were enrolled in a study using radiofrequency energy to ablate the BVN within the vertebral bodies adjacent to the diagnosed level. Patients were evaluated at 6 weeks, and 3, 6, and 12 months postoperatively. PATIENT SAMPLE: Seventeen patients with chronic, greater than 6 months, low back pain unresponsive to at least 3 months of conservative care were enrolled. Sixteen patients were treated successfully following screening using magnetic resonance imaging finding of Modic type I or II changes and positive confirmatory discography to determine the affected levels. The treated population consisted of eight male and eight female patients; the mean age was 48 years (34-66 years). OUTCOME MEASURES: Self-reported outcome measures were collected prospectively at each follow-up interval. Measures included the Oswestry Disability Index (ODI), visual analogue scale score, and Medical Outcomes Trust 36-Item Short-Form Health Survey (SF-36). MATERIALS AND METHODS: This is an industry-sponsored study to evaluate the effectiveness of intraosseous nerves in the treatment of chronic back pain. Consented and enrolled patients underwent ablation of the BVN using radiofrequency energy (INTRACEPT System, Relievant Medsystems, Inc, Redwood City, CA, USA) guided in a transpedicular or extrapedicular approach. Preoperative planning determined targeted ablation zone and safety zones. RESULTS: Mean baseline ODI of the treated cohort was 52 +/- 13, decreasing to a mean of 23 +/- 21 at 3 months follow-up (p<.001). The statistically significant improvement in ODI observed at 3 months was maintained through the 12-month follow-up. The mean baseline visual analogue scale score decreased from 61 +/- 22 to 45 +/- 35 at 3 months follow-up (p<.05), and the mean baseline physical component summary increased from 34.5 +/- 6.5 to 41.7 +/- 12.4 at 3 months follow-up (p=.03). CONCLUSION: Ablation of the BVN for the treatment of chronic lumbar back pain significantly improves patients' self-reported outcome early in the follow-up period; the improvement persisted throughout the 1-year study period. Published by Elsevier Inc.