Evidence map›Paper›PMID 35141598›Full record

ArticleNorth American Spine Society journal2020

A prospective, single arm study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results.

K Macadaeg, E Truumees, B Boody, E Pena, J Arbuckle, J Gentile, R Funk, D Singh, S Vinayek

Erratum issued Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in North American Spine Society journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. 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 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 9% 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

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

K MacadaegIndiana Spine Group, 13225N Meridian St, Carmel, IN 46032, United States.
E TruumeesProfessor of Orthopedics and Neurosurgery, University of Texas, Dell Medical School, Ascension Texas Spine and Scoliosis Center, Austin, TX, United States.
B BoodyIndiana Spine Group, 13225N Meridian St, Carmel, IN 46032, United States.
E PenaAscension Texas Spine and Scoliosis Center, Austin, TX, United States.
J ArbuckleIndiana Spine Group, 13225N Meridian St, Carmel, IN 46032, United States.
J GentileIndiana Spine Group, 13225N Meridian St, Carmel, IN 46032, United States.
R FunkIndiana Spine Group, 13225N Meridian St, Carmel, IN 46032, United States.
D SinghAscension Texas Spine and Scoliosis Center, Austin, TX, United States.
S VinayekIndiana Spine Group, 13225N Meridian St, Carmel, IN 46032, United States.
Indiana Spine Group · USAscension Via Christi · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The basivertebral nerve (BVN) has been a recently discovered target as a potential source for vertebrogenic chronic low back pain (CLBP). Prior randomized controlled trials have demonstrated safety and efficacy of BVN ablation for vertebrogenic CLBP, but minimal data exists regarding BVN ablation's clinical effectiveness with broader application outside of strict trial inclusion criteria. Methods: Prospective, single arm, open label effectiveness trial of 48 patients from community spine and pain practices treated with BVN ablation. Inclusion criteria required more than 6 months of CLBP and type 1 or 2 Modic changes on MRI to be enrolled. Patients were followed post procedure for 12 months using ODI, VAS, EQ-5D-5L and SF-36 patient reported outcome metrics.Results: 47 patients successfully received BVN ablation and 45 patients completed 12 months of follow up. Mean reduction in ODI at 12 months was 32.31 +/- 14.07 (p<0.001) with 88.89% (40/45) patients reporting a ≥15 point ODI decrease at 12 months. Mean VAS pain score decrease was 4.31+/-2.51 at 12 months (p<0.001) and more than 69% reported a 50% reduction in VAS pain scale. Similarly, SF-36 and EQ-5D-5L scores improved 26.27+/-17.19 and 0.22+/-0.15 (each p<0.001). Conclusions: This data supports the clinical effectiveness of BVN ablation in the community practice setting, with similar 12 month improvements in patient reported outcomes as seen in previously published randomized control trials.

Identifiers

PMID35141598
PMCPMC8819913
OpenAlexW3090944202

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.