Evidence map›Paper›PMID 39624017›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2025

Efficacy of a Tumor Necrosis Factor Inhibitor in Chronic Low-Back Pain With Modic Type 1 Changes: A Randomized Controlled Trial.

Elisabeth Gjefsen, Lars C Bråten, Erica Ponzi, Magnhild H Dagestad, Gunn H Marchand, Thomas Kadar, Gunnstein Bakland, Anne J Haugen, Fredrik Granviken, Tonje W Flørenes and 12 more

Abstract readRandomized Controlled TrialMulticenter StudyEquivalence Trial
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Association between MRI findings and inflammatory symptoms in non-specific chronic low back pain.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 · 2025
    Article
  4. Review
  5. Modic Changes and Tumor Necrosis Factor Inhibition: Is the Door Shut?Arthritis & rheumatology (Hoboken, N.J.) · 2025
    Article
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

22 authors.

Elisabeth GjefsenOslo University Hospital and University of Oslo, Oslo, Norway.ORCID 0000-0003-0470-7225
Lars C BråtenOslo University Hospital, Oslo, Norway.
Erica PonziOslo University Hospital, Oslo, Norway.
Magnhild H DagestadHaukeland University Hospital and University of Bergen, Bergen, Norway.
Gunn H MarchandSt Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.
Thomas KadarHaukeland University Hospital, Bergen, Norway.
Gunnstein BaklandUniversity Hospital of North Norway, Tromsø, Norway.
Anne J HaugenØstfold Hospital Trust, Grålum, Norway.
Fredrik GranvikenSt Olav's Hospital, Trondheim University Hospital and Norwegian University of Science and Technology, Trondheim, Norway.
Tonje W FlørenesHaukeland University Hospital and University of Bergen, Bergen, Norway.
Nils VettiHaukeland University Hospital and University of Bergen, Bergen, Norway.
Lars GrøvleØstfold Hospital Trust, Grålum, Norway.
Aksel T NilsenUniversity Hospital of North Norway, Tromsø, Norway.ORCID 0000-0001-9821-8785
Astrid LunestadNorwegian Association for Female Pelvic Joint Health, Grønland, Oslo, Norway.
Thor E HolmgardNorwegian Back Pain Association, Drammen, Norway.
Morten ValbergOslo University Hospital and University of Oslo, Oslo, Norway.
Nils BolstadOslo University Hospital, Oslo, Norway.
Ansgar EspelandHaukeland University Hospital and University of Bergen, Bergen, Norway.
Jens I BroxOslo University Hospital and University of Oslo, Oslo, Norway.
Guro L GollDiakonhjemmet Hospital and University of Oslo, Oslo, Norway.ORCID 0000-0002-8506-725X
Kjersti StorheimOslo University Hospital and Oslo Metropolitan University, Oslo, Norway.
John-Anker ZwartOslo University Hospital and University of Oslo, Oslo, Norway.

Funding

Klinbeforsk no 2017201
6 · The paper itself

Abstract

objectiveThe efficacy of tumor necrosis factor inhibitors for treating chronic low-back pain with Modic changes is uncertain. This study investigated the superiority of infliximab over placebo in patients with Modic type 1 changes.

methodsIn this multicenter, randomized, triple-blind, placebo-controlled trial, patients aged 18 to 65 years with moderate to severe chronic low-back pain and Modic type 1 changes were enrolled from five Norwegian public hospitals between January 2019 and October 2022. Participants were randomly assigned to four intravenous infusions of 5 mg/kg infliximab or placebo. The primary outcome was difference in change in the Oswestry Disability Index (ODI) score from baseline to five months. Secondary outcomes included changes in low-back pain intensity, disability, and health-related quality of life. A linear mixed model was used for efficacy analyses.

resultsA total of 128 patients (mean age 43 years, 65.6% women) participated (64 in each group). All patients who received at least one dose of the allocated infusion were included in the primary analyses. The average ODI score (±SD) change was -7.0 (±9.7) in the group who received infliximab and -6.4 (±10.4) in the group who received placebo. The difference in the ODI score change between the two groups was 1.3 ODI points (95% confidence interval -2.1 to 4.6, P = 0.45). Analyses showed no effect of infliximab compared to placebo on secondary outcomes. Adverse event rates were similar between groups.

conclusionInfliximab did not demonstrate superiority over placebo in reducing pain-related disability in patients with moderate to severe chronic low-back pain with Modic type 1 changes at five months.

Indexed as

Chronic PainInfliximabLow Back PainTumor Necrosis Factor InhibitorsAdolescentAdultAgedDisability EvaluationDouble-Blind MethodFemaleHumansMaleMiddle AgedQuality of LifeTreatment OutcomeYoung AdultInfliximabTumor Necrosis Factor Inhibitors

Identifiers

PMID39624017
PMCPMC12039465

What OpenQuestion holds

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Registered trials

None linked

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.