A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain

Eeric Truumees, Kevin Macadaeg, Enrique Pena, John Arbuckle, Jonathan Gentile, Robert Funk, Devender Singh, Sheetal Vinayek

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Purpose: A prospective, single-arm, open-label study to evaluate the effectiveness of intraosseous radio frequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of vertebrogenic-related chronic low back pain (CLBP) in typical spine practice settings using permissive criteria for study inclusion. Methods: Consecutive patients with CLBP of at least 6 months duration and with Modic Type 1 or 2 vertebral endplate changes between L3 and S1 were treated with RF ablation of the BVN in up to four vertebral bodies. The primary endpoint was patient-reported change in Oswestry Disability Index (ODI) from baseline to 3 months post-procedure. Secondary outcome measures included change in visual analog scale (VAS), SF-36, EQ-5D-5L, and responder rates. Results: Median age was 45 years; baseline ODI was 48.5; VAS was 6.36. Seventy-five percent (75%) of the study patients reported LBP symptoms for ≥ 5 years; 25% were actively using opioids; and 61% were previously treated with injections. Mean change in ODI at 3 months posttreatment was − 30.07 +14.52 points (p < 0.0001); mean change in VAS was − 3.50 + 2.33 (p < 0.0001). Ninety-three percent (93%) of patients achieved a ≥ 10-point improvement in ODI, and 75% reported ≥ 20-point improvement. Conclusions: Minimally invasive RF ablation of the BVN demonstrated a significant improvement in pain and function in this population of real-world patients with chronic vertebrogenic-related LBP. Graphical abstract: These slides can be retrieved under Electronic Supplementary Material.[Figure not available: see fulltext.]

Original languageEnglish (US)
Pages (from-to)1594-1602
Number of pages9
JournalEuropean Spine Journal
Volume28
Issue number7
DOIs
StatePublished - Jul 1 2019

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Low Back Pain
Visual Analog Scale
Radio
Therapeutics
Opioid Analgesics
Spine
Outcome Assessment (Health Care)
Pain
Injections
Population

Keywords

  • Basivertebral nerve
  • Chronic low back pain
  • Endplate degeneration
  • Modic
  • Radiofrequency ablation
  • Vertebrogenic pain

ASJC Scopus subject areas

  • Surgery
  • Orthopedics and Sports Medicine

Cite this

A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. / Truumees, Eeric; Macadaeg, Kevin; Pena, Enrique; Arbuckle, John; Gentile, Jonathan; Funk, Robert; Singh, Devender; Vinayek, Sheetal.

In: European Spine Journal, Vol. 28, No. 7, 01.07.2019, p. 1594-1602.

Research output: Contribution to journalArticle

Truumees, Eeric ; Macadaeg, Kevin ; Pena, Enrique ; Arbuckle, John ; Gentile, Jonathan ; Funk, Robert ; Singh, Devender ; Vinayek, Sheetal. / A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. In: European Spine Journal. 2019 ; Vol. 28, No. 7. pp. 1594-1602.
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abstract = "Purpose: A prospective, single-arm, open-label study to evaluate the effectiveness of intraosseous radio frequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of vertebrogenic-related chronic low back pain (CLBP) in typical spine practice settings using permissive criteria for study inclusion. Methods: Consecutive patients with CLBP of at least 6 months duration and with Modic Type 1 or 2 vertebral endplate changes between L3 and S1 were treated with RF ablation of the BVN in up to four vertebral bodies. The primary endpoint was patient-reported change in Oswestry Disability Index (ODI) from baseline to 3 months post-procedure. Secondary outcome measures included change in visual analog scale (VAS), SF-36, EQ-5D-5L, and responder rates. Results: Median age was 45 years; baseline ODI was 48.5; VAS was 6.36. Seventy-five percent (75{\%}) of the study patients reported LBP symptoms for ≥ 5 years; 25{\%} were actively using opioids; and 61{\%} were previously treated with injections. Mean change in ODI at 3 months posttreatment was − 30.07 +14.52 points (p < 0.0001); mean change in VAS was − 3.50 + 2.33 (p < 0.0001). Ninety-three percent (93{\%}) of patients achieved a ≥ 10-point improvement in ODI, and 75{\%} reported ≥ 20-point improvement. Conclusions: Minimally invasive RF ablation of the BVN demonstrated a significant improvement in pain and function in this population of real-world patients with chronic vertebrogenic-related LBP. Graphical abstract: These slides can be retrieved under Electronic Supplementary Material.[Figure not available: see fulltext.]",
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AU - Truumees, Eeric

AU - Macadaeg, Kevin

AU - Pena, Enrique

AU - Arbuckle, John

AU - Gentile, Jonathan

AU - Funk, Robert

AU - Singh, Devender

AU - Vinayek, Sheetal

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N2 - Purpose: A prospective, single-arm, open-label study to evaluate the effectiveness of intraosseous radio frequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of vertebrogenic-related chronic low back pain (CLBP) in typical spine practice settings using permissive criteria for study inclusion. Methods: Consecutive patients with CLBP of at least 6 months duration and with Modic Type 1 or 2 vertebral endplate changes between L3 and S1 were treated with RF ablation of the BVN in up to four vertebral bodies. The primary endpoint was patient-reported change in Oswestry Disability Index (ODI) from baseline to 3 months post-procedure. Secondary outcome measures included change in visual analog scale (VAS), SF-36, EQ-5D-5L, and responder rates. Results: Median age was 45 years; baseline ODI was 48.5; VAS was 6.36. Seventy-five percent (75%) of the study patients reported LBP symptoms for ≥ 5 years; 25% were actively using opioids; and 61% were previously treated with injections. Mean change in ODI at 3 months posttreatment was − 30.07 +14.52 points (p < 0.0001); mean change in VAS was − 3.50 + 2.33 (p < 0.0001). Ninety-three percent (93%) of patients achieved a ≥ 10-point improvement in ODI, and 75% reported ≥ 20-point improvement. Conclusions: Minimally invasive RF ablation of the BVN demonstrated a significant improvement in pain and function in this population of real-world patients with chronic vertebrogenic-related LBP. Graphical abstract: These slides can be retrieved under Electronic Supplementary Material.[Figure not available: see fulltext.]

AB - Purpose: A prospective, single-arm, open-label study to evaluate the effectiveness of intraosseous radio frequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of vertebrogenic-related chronic low back pain (CLBP) in typical spine practice settings using permissive criteria for study inclusion. Methods: Consecutive patients with CLBP of at least 6 months duration and with Modic Type 1 or 2 vertebral endplate changes between L3 and S1 were treated with RF ablation of the BVN in up to four vertebral bodies. The primary endpoint was patient-reported change in Oswestry Disability Index (ODI) from baseline to 3 months post-procedure. Secondary outcome measures included change in visual analog scale (VAS), SF-36, EQ-5D-5L, and responder rates. Results: Median age was 45 years; baseline ODI was 48.5; VAS was 6.36. Seventy-five percent (75%) of the study patients reported LBP symptoms for ≥ 5 years; 25% were actively using opioids; and 61% were previously treated with injections. Mean change in ODI at 3 months posttreatment was − 30.07 +14.52 points (p < 0.0001); mean change in VAS was − 3.50 + 2.33 (p < 0.0001). Ninety-three percent (93%) of patients achieved a ≥ 10-point improvement in ODI, and 75% reported ≥ 20-point improvement. Conclusions: Minimally invasive RF ablation of the BVN demonstrated a significant improvement in pain and function in this population of real-world patients with chronic vertebrogenic-related LBP. Graphical abstract: These slides can be retrieved under Electronic Supplementary Material.[Figure not available: see fulltext.]

KW - Basivertebral nerve

KW - Chronic low back pain

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KW - Modic

KW - Radiofrequency ablation

KW - Vertebrogenic pain

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