Evidence map›Paper›PMID 31115683›Full record

Trial reportEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2019

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

Registry-linked trialOpen access · hybridAbstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05207813 (A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain Long-term Follow Up), which is not on this map. Cited by 38 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 3 pooled it
4.3field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05207813 completednot on this mapstarted 2022, after this paper: background citation

A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain Long-term Follow Up

TypeobservationalSponsorBoston Scientific CorporationRan2022 to 2024Enrolled42ConditionsChronic Low Back PainArmsIntracept Procedure
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 3 syntheses or guidelines pooled it, 52 citations in OpenAlex.

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  4. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Eeric TruumeesSeton Spine and Scoliosis Center, University of Texas, Orthopaedic Surgery, 1600 West 38th Street, Suite 200, Austin, TX, 78731, USA. etruumees@ascension.org.ORCID http://orcid.org/0000-0002-3319-3270
Kevin MacadaegIndiana Spine Group, 13225 N. Meridian St, Carmel, IN, 46032, USA.
Enrique PenaSeton Spine and Scoliosis Center, University of Texas, Orthopaedic Surgery, 1600 West 38th Street, Suite 200, Austin, TX, 78731, USA.
John ArbuckleIndiana Spine Group, 13225 N. Meridian St, Carmel, IN, 46032, USA.
Jonathan GentileIndiana Spine Group, 13225 N. Meridian St, Carmel, IN, 46032, USA.
Robert FunkIndiana Spine Group, 13225 N. Meridian St, Carmel, IN, 46032, USA.
Devender SinghSeton Spine and Scoliosis Center, University of Texas, Orthopaedic Surgery, 1600 West 38th Street, Suite 200, Austin, TX, 78731, USA.
Sheetal VinayekIndiana Spine Group, 13225 N. Meridian St, Carmel, IN, 46032, USA.
Indiana Spine Group · USCentral Texas Spine Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeA 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.

methodsConsecutive 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.

resultsMedian 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.

conclusionsMinimally 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. These slides can be retrieved under Electronic Supplementary Material.

Indexed as

AdultCatheter AblationChronic PainFemaleFollow-Up StudiesHumansLow Back PainMaleMiddle AgedNeurosurgical ProceduresPatient Reported Outcome MeasuresProspective StudiesRecovery of FunctionTreatment OutcomeBasivertebral nerveChronic low back painEndplate degenerationModicRadiofrequency ablationVertebrogenic pain

Identifiers

PMID31115683
OpenAlexW2945891159

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.