Skip to main content

Main menu

  • Home
  • Content
    • Current
    • Latest
    • Archive
  • About Us
    • About ISASS
    • About the Journal
    • Author Instructions
    • Editorial Board
    • Reviewer Guidelines & Publication Criteria
  • More
    • Alerts
    • Feedback
  • Join Us
  • Reprints & Permissions
  • Other Publications
    • ijss

User menu

  • My alerts

Search

  • Advanced search
International Journal of Spine Surgery
  • My alerts
International Journal of Spine Surgery

Advanced Search

  • Home
  • Content
    • Current
    • Latest
    • Archive
  • About Us
    • About ISASS
    • About the Journal
    • Author Instructions
    • Editorial Board
    • Reviewer Guidelines & Publication Criteria
  • More
    • Alerts
    • Feedback
  • Join Us
  • Reprints & Permissions
  • Follow ijss on Twitter
  • Visit ijss on Facebook
Research ArticleLumbar Spine

Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study

Jeffrey S. Fischgrund, Alfred Rhyne, Jörg Franke, Rick Sasso, Scott Kitchel, Hyun Bae, Christopher Yeung, Eeric Truumees, Michael Schaufele, Philip Yuan, Peter Vajkoczy, Michael Depalma, David G. Anderson, Lee Thibodeau and Bernhard Meyer
International Journal of Spine Surgery April 2019, 6015; DOI: https://doi.org/10.14444/6015
Jeffrey S. Fischgrund
Department of Orthopedic Surgery, Oakland University, William Beaumont School of Medicine, Royal Oak, Michigan
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Alfred Rhyne
OrthoCarolina Spine Center, Charlotte, North Carolina
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Jörg Franke
Department of Orthopedics-Spine and Pediatric Orthopedics, Klinikum Magdeburg gGmbH, Magdeburg, Germany
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Rick Sasso
Department of Orthopedic Surgery, Indiana University School of Medicine, Indianapolis, Indiana
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Scott Kitchel
NeuroSpine Institute, Eugene, Oregon
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Hyun Bae
Department of Surgery, Cedars Sinai Medical Center, Los Angeles, California
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Christopher Yeung
Desert Institute for Spine Care, Phoenix, Arizona
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Eeric Truumees
Seton Brain & Spine Institute, Department of Surgery, Dell Medical School, Seton Spine & Scoliosis Center, Austin, Texas
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Michael Schaufele
Pain Solutions Treatment Centers, Marietta, Georgia
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Philip Yuan
Department of Surgery, Long Beach Memorial Medical Center, Long Beach, California
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Peter Vajkoczy
Department of Neurosugery, Charité Universitätsmedizin, Berlin Campus, Virchow Medical Center, Berlin, Germany
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Michael Depalma
Virginia iSpine Physicians, Richmond, Virginia
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
David G. Anderson
Department of Orthopaedic and Neurological Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Lee Thibodeau
Maine Spine Surgery, Portland, Maine
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Bernhard Meyer
Direktor der Neurochirurgische Klinik und Poliklinik, Technischen Universität München, Klinikum rechts der Isar, Munich, Germany
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Info & Metrics
  • PDF
Loading

ABSTRACT

Background The purpose of the present study is to report the 2-year clinical outcomes for chronic low back pain (CLBP) patients treated with radiofrequency (RF) ablation of the basivertebral nerve (BVN) in a randomized controlled trial that previously reported 1-year follow up.

Methods A total of 147 patients were treated with RF ablation of the BVN in a randomized controlled trial designed to demonstrate safety and efficacy as part of a Food and Drug Administration-Investigational Device Exemption trial. Evaluations, including patient self-assessments, physical and neurological examinations, and safety assessments, were performed at 2 and 6 weeks, and 3, 6, 12, 18, and 24 months postoperatively. Participants randomized to the sham control arm were allowed to cross to RF ablation at 12 months. Due to a high rate of crossover, RF ablation treated participants acted as their own control in a comparison to baseline for the 24-month outcomes.

Results Clinical improvements in the Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and the Medical Outcomes Trust Short-Form Health Survey Physical Component Summary were statistically significant compared to baseline at all follow-up time points through 2 years. The mean percent improvements in ODI and VAS compared to baseline at 2 years were 53.7 and 52.9%, respectively. Responder rates for ODI and VAS were also maintained through 2 years with patients showing clinically meaningful improvements in both: ODI ≥ 10-point improvement in 76.4% of patients and ODI ≥ 20-point improvement in 57.5%; VAS ≥ 1.5 cm improvement in 70.2% of patients.

Conclusions Patients treated with RF ablation of the BVN for CLBP exhibited sustained clinical benefits in ODI and VAS and maintained high responder rates at 2 years following treatment. Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of CLBP.

  • chronic low back pain
  • basivertebral nerve
  • radiofrequency ablation

Footnotes

  • Disclosures and COI: Rick Sasso, Scott Kitchel, Hyun Bae, Christopher Yeung, Eeric Truummees, Philip Yuan, Peter Vajkoczy, Michael DePalma, and Lee Thibodeau have no disclosures to report. Jeffrey S. Fischgrund reports consultancy for Relievant. Alfred Rhyne reports consultancy for Relievant. Jörg Franke reports consultancy and an honoraria from Relievant. Michael Schaufele reports consultancy for Relievant. David G. Anderson reports consultancy for DePuy Synthes Spine, K2M Spine, and Integrity Spine. Bernhard Meyer reports honoraria, travel support, consultancies, and funded research by Medtronic, DePuy, Umrich, Icotech, Spineart, and Relievant. Research Oversight and Ethics: This research was conducted under the oversight of the Western Institutional Review Board and the investigational site's local institutional review board. Informed consent was obtained for participants in this study. This research was conducted in accordance with the Helsinki Declaration.

  • ©International Society for the Advancement of Spine Surgery
Back to top

In this issue

International Journal of Spine Surgery: 13 (5)
International Journal of Spine Surgery
Vol. 13, Issue 5
1 Oct 2019
  • Table of Contents
  • Index by author
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word on International Journal of Spine Surgery.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study
(Your Name) has sent you a message from International Journal of Spine Surgery
(Your Name) thought you would like to see the International Journal of Spine Surgery web site.
Citation Tools
Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study
Jeffrey S. Fischgrund, Alfred Rhyne, Jörg Franke, Rick Sasso, Scott Kitchel, Hyun Bae, Christopher Yeung, Eeric Truumees, Michael Schaufele, Philip Yuan, Peter Vajkoczy, Michael Depalma, David G. Anderson, Lee Thibodeau, Bernhard Meyer
International Journal of Spine Surgery Apr 2019, 6015; DOI: 10.14444/6015

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study
Jeffrey S. Fischgrund, Alfred Rhyne, Jörg Franke, Rick Sasso, Scott Kitchel, Hyun Bae, Christopher Yeung, Eeric Truumees, Michael Schaufele, Philip Yuan, Peter Vajkoczy, Michael Depalma, David G. Anderson, Lee Thibodeau, Bernhard Meyer
International Journal of Spine Surgery Apr 2019, 6015; DOI: 10.14444/6015
del.icio.us logo Digg logo Reddit logo Twitter logo CiteULike logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • Scopus
  • Google Scholar

Cited By...

  • No citing articles found.
  • Scopus (2)
  • Google Scholar

More in this TOC Section

  • Use of a Reverse Bohlman Technique for Low-Grade Spondylolisthesis
  • Effects of Operating Room Size on Surgical Site Infection Following Lumbar Fusion Surgery
  • Comparative Efficacy of Commonly Available Human Bone Graft Substitutes as Tested for Posterolateral Fusion in an Athymic Rat Model
Show more Lumbar Spine

Similar Articles

Keywords

  • chronic low back pain
  • basivertebral nerve
  • radiofrequency ablation

Content

  • Current Issue
  • Latest Content
  • Archive

More Information

  • About IJSS
  • About ISASS

More

  • Alerts
  • Feedback

Other Services

  • Author Instructions
  • Join ISASS
  • Reprints & Permissions

© 2019 International Journal of Spine Surgery

International Journal of Spine Surgery Online ISSN: 2211-4599

Powered by HighWire