Evidence map›Paper›PMID 32451777›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 Society2020

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.

Jeffrey S Fischgrund, Alfred Rhyne, Kevin Macadaeg, Gregory Moore, Evish Kamrava, Christopher Yeung, Eeric Truumees, Michael Schaufele, Philip Yuan, Michael DePalma and 4 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
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, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05660512 (A Prospective Single Arm Cohort Study of Intraosseous Basivertebral Nerve Ablation), which is not on this map. Cited by 62 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 3 pooled it
7.2field-weighted citation impact, top 2% 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.

NCT05660512 active not recruitingnot on this map

A Prospective Single Arm Cohort Study of Intraosseous Basivertebral Nerve Ablation

TypeobservationalSponsorUniversity of UtahRan2020 to 2026Enrolled150ConditionsLow Back PainArmsIntracept Procedure
3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 3 syntheses or guidelines pooled it, 92 citations in OpenAlex.

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2 more citing papers are in PubMed but not listed here.

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

14 authors at 12 institutions in 1 country.

Jeffrey S FischgrundWilliam Beaumont Hospital, Oakland University School of Medicine, 3601 W 13 Mile Road, Royal Oak, MI, 48073, USA. jsfischgrund37@gmail.com.ORCID http://orcid.org/0000-0003-4658-5991
Alfred RhyneOrthoCarolina Spine Center, 2001 Randolph Road, Charlotte, NC, 28207, USA.
Kevin MacadaegIndiana Spine Group, 13225 North Meridian Street, Carmel, IN, 46032, USA.
Gregory MoorePacific Sports and Spine, 74B Centennial Loop, Suite 300, Eugene, OR, 97401, USA.
Evish KamravaThe Spine Institute, 2811 Wilshire Boulevard, Suite 850, Santa Monica, CA, 90403, USA.
Christopher YeungDesert Institute for Spine Care, 1635 E Myrtle Avenue, Suite 400, Phoenix, AZ, 85020, USA.
Eeric TruumeesSeton Spine & Scoliosis Center, 1600 West 38th Street, Suite 200, Austin, TX, 78731, USA.
Michael SchaufeleDrug Studies America, 400 Tower Road NE, Suite 150, Marietta, GA, 30060, USA.
Philip YuanMemorial Orthopedic Surgical Group, Department of Surgery, Long Beach Memorial Medical Center, 2760 Atlantic Avenue, Long Beach, CA, 90806, USA.
Michael DePalmaVirginia iSpine Physicians, 9020 Stony Point Parkway, S-140, Richmond, VA, 23235, USA.
David Greg AndersonRothman Orthopedic Institute, 3300 Tillman Drive, 2nd Floor, Glenview Corporate Center, Bensalem, PA, 19020, USA.
Douglas BuxtonMaine Medical Partners Neurosurgery and Spine, 195 Fore River Parkway, Suite 490, Portland, ME, 04102, USA.
James ReynoldsSpine Care Medical Group, 455 Hickey Boulevard, Suite 310, Daly City, CA, 94015, USA.
Michael SikorskyMichigan Orthopedic Institute, 26025 Lahser Road, Suite 200B, Southfield, MI, 48033, USA.
Cardiovascular Medical Group · USDesert Institute For Spine Care · USDrug Studies America · USIndiana Spine Group · USMaine Medical Center · USMemorialCare Long Beach Medical Center · USOakland University · USOrthoCarolina · USOrthopedic Institute · USRothman Orthopaedics · USThe Spine Institute · USVirginia Spine Research Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDamaged or degenerated vertebral endplates are a significant cause of vertebrogenic chronic low back pain (CLBP). Modic changes are one objective MRI biomarker for these patients. Prior data from the treatment arm of a sham-controlled, RCT showed maintenance of clinical improvements at 2 years following ablation of the basivertebral nerve (BVN). This study reports 5-year clinical outcomes.

methodsIn total, 117 US patients were treated successfully with BVN ablation. Patient-reported outcomes of ODI, VAS, postablation treatments, and patient satisfaction were collected at a minimum of 5-years following BVN ablation. Primary outcome was mean change in ODI. Comparisons between the postablation and baseline values were made using an analysis of covariance with alpha 0.05.

resultsOf the 117 US treated patients 100 (85%) were available for review with a mean follow-up of 6.4 years (5.4-7.8 years). Mean ODI score improved from 42.81 to 16.86 at 5-year follow-up, a reduction of 25.95 points (p < 0.001). Mean reduction in VAS pain score was 4.38 points (baseline of 6.74, p < 0.001). In total, 66% of patients reported a > 50% reduction in pain, 47% reported a > 75% reduction in pain, and 34% of patients reported complete pain resolution. Composite responder rate using thresholds of ≥ 15-point ODI and ≥ 2-point VAS for function and pain at 5 years was 75%.

conclusionCLBP patients treated with BVN ablation exhibit sustained clinical improvements in function and pain with high responder rates at a mean of 6.4 years following treatment. BVN ablation is a durable, minimally invasive treatment for vertebrogenic CLBP.

Indexed as

Chronic PainLow Back PainDouble-Blind MethodHumansPatient Reported Outcome MeasuresProspective StudiesTreatment OutcomeBasivertebral nerveChronic low back painModicRadiofrequency ablationRandomized controlled trial

Identifiers

PMID32451777
OpenAlexW3032043376

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.