Abstract
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.
Keywords
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Article info
Publication history
Published online: September 01, 2016
Accepted:
August 29,
2016
Received in revised form:
August 24,
2016
Received:
May 9,
2016
Footnotes
FDA device/drug status: Approved (Intracept Flexible Bi-Polar RF Probe and Easy Access Instrument Set).
Author disclosures: SB: Relievant Medsystems, Inc. (C), outside the submitted work. AH: Nothing to disclose. MHH: Royalties: Relievant Medsystems, Inc. (C), outside the submitted work; Consulting: Relievant Medsystems, Inc. (B), outside the submitted work.
Identification
Copyright
Published by Elsevier Inc.
