Evidence map›Paper›PMID 33087100›Full record

ArticleBMC musculoskeletal disorders2020

The effect of infliximab in patients with chronic low back pain and Modic changes (the BackToBasic study): study protocol of a randomized, double blind, placebo-controlled, multicenter trial.

Elisabeth Gjefsen, Lars Christian Haugli Bråten, Guro Løvik Goll, Monica Wigemyr, Nils Bolstad, Morten Valberg, Elina Iordanova Schistad, Gunn Hege Marchand, Fredrik Granviken, Kaja Kristine Selmer and 17 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC musculoskeletal disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03704363 (The Effect of Infliximab in Patients With Chronic Low Back Pain and Modic Changes. A Randomized, Double Blind, Placebo-controlled, Multicenter Trial), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.4field-weighted citation impact, top 19% 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.

NCT03704363 phase3completednot on this map

The Effect of Infliximab in Patients With Chronic Low Back Pain and Modic Changes. A Randomized, Double Blind, Placebo-controlled, Multicenter Trial

TypeinterventionalSponsorOslo University HospitalRan2018 to 2023Enrolled128ConditionsLow Back PainArmsBiosimilar Infliximab, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Mechanism-based nonopioid analgesic targets.The Journal of clinical investigation · 2025
    Review
  3. Review
  4. Modic Changes and Tumor Necrosis Factor Inhibition: Is the Door Shut?Arthritis & rheumatology (Hoboken, N.J.) · 2025
    Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Review
  10. Monoclonal Antibodies for Chronic Pain Treatment: Present and Future.International journal of molecular sciences · 2021
    Review
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

27 authors at 8 institutions in 1 country.

Elisabeth GjefsenResearch and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital HF, Ulleval, Bygg 37b, P.O. Box 4956 Nydalen, 0424, Oslo, Norway. e.gjefsen@gmail.com.ORCID http://orcid.org/0000-0003-0470-7225
Lars Christian Haugli BråtenResearch and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital HF, Ulleval, Bygg 37b, P.O. Box 4956 Nydalen, 0424, Oslo, Norway.
Guro Løvik GollDepartment of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, 0319, Oslo, Norway.
Monica WigemyrDepartment of Research and Innovation, Division of Clinical Neuroscience, Oslo University Hospital, P.O. Box 4956 Nydalen, 0424, Oslo, Norway.
Nils BolstadDepartment of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Box 4953 Nydalen, 0424, Oslo, Norway.
Morten ValbergOslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Sogn Arena 3.etg, P.O.Box 4950 Nydalen, Oslo, Norway.
Elina Iordanova SchistadDepartment of Physical Medicine and Rehabilitation, Oslo University Hospital HF, P.O. Box 4956 Nydalen, 0424, Oslo, Norway.
Gunn Hege MarchandDepartment of Physical Medicine and Rehabilitation, St. Olavs Hospital, Trondheim University Hospital, P.O. Box 3250 Torgarden, NO-7006, Trondheim, Norway.
Fredrik GranvikenDepartment of Physical Medicine and Rehabilitation, St. Olavs Hospital, Trondheim University Hospital, P.O. Box 3250 Torgarden, NO-7006, Trondheim, Norway.
Kaja Kristine SelmerDepartment of Research and Innovation, Division of Clinical Neuroscience, Oslo University Hospital, P.O. Box 4956 Nydalen, 0424, Oslo, Norway.
Anne FroholdtDepartment of Physical Medicine and Rehabilitation, Drammen Hospital, Vestre Viken Hospital Trust Drammen, P.O. Box 800, 3004, Drammen, Norway.
Anne Julsrud HaugenDepartment of Rheumatology, Østfold Hospital Trust, P.O. Box 300, 1714 Grålum, Moss, Norway.
Magnhild Hammersland DagestadDepartment of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.
Nils VettiDepartment of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.
Gunnstein BaklandDepartment of Rheumatology, University Hospital of North Norway, P.O. Box 100, 9038, Tromsø, Norway.
Benedicte Alexandra LieDepartment of Medical Genetics, University of Oslo and Oslo University Hospital, P.O. Box 4956 Nydalen, 0424, Oslo, Norway.
Espen A HaavardsholmDepartment of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, 0319, Oslo, Norway.
Aksel Thuv NilsenDepartment of Rheumatology, University Hospital of North Norway, P.O. Box 100, 9038, Tromsø, Norway.
Thor Einar HolmgardNorwegian Back Pain Association, P.O.Box 9612 Fjellhagen, 3065, Drammen, Norway.
Thomas Istvan KadarDepartment of Physical Medicine and Rehabilitation, Haukeland University Hospital, Helse Bergen HF, Box 1, 5021, Bergen, Norway.
Tore KvienFaculty of Medicine, University of Oslo, P.O. Box 1072 Blindern, 0316, Oslo, Norway.
Jan Sture SkouenDepartment of Physical Medicine and Rehabilitation, Haukeland University Hospital, Helse Bergen HF, Box 1, 5021, Bergen, Norway.
Lars GrøvleDepartment of Rheumatology, Østfold Hospital Trust, P.O. Box 300, 1714 Grålum, Moss, Norway.
Jens Ivar BroxFaculty of Medicine, University of Oslo, P.O. Box 1072 Blindern, 0316, Oslo, Norway.
Ansgar EspelandDepartment of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.
Kjersti StorheimResearch and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital HF, Ulleval, Bygg 37b, P.O. Box 4956 Nydalen, 0424, Oslo, Norway.
John Anker ZwartFaculty of Medicine, University of Oslo, P.O. Box 1072 Blindern, 0316, Oslo, Norway.
Oslo University Hospital · NOHaukeland University Hospital · NODiakonhjemmet Hospital · NONorwegian University of Science and Technology · NOØstfold Hospital Trust · NOUniversity Hospital of North Norway · NODrammen Hospital · NOUniversity of Oslo · NO

Funding

Klinbeforsk 18/00015-2
6 · The paper itself

Abstract

backgroundLow back pain is common and a significant number of patients experience chronic low back pain. Current treatment options offer small to moderate effects. Patients with vertebral bone marrow lesions visualized as Modic changes on magnetic resonance imaging may represent a subgroup within the low back pain population. There is evidence for inflammatory mediators being involved in development of Modic changes; hence, suppression of inflammation could be a treatment strategy for these patients. This study examines the effect of anti-inflammatory treatment with the TNF-α inhibitor infliximab in patients with chronic low back pain and Modic changes. METHODS/

designThe BackToBasic trial is a multicenter, double blind, randomized controlled trial conducted at six hospitals in Norway, comparing intravenous infusions with infliximab with placebo. One hundred twenty-six patients aged 18-65 with chronic low back pain and type 1 Modic changes will be recruited from secondary care outpatients' clinics. The primary outcome is back pain-specific disability at day 154 (5 months). The study is designed to detect a difference in change of 10 (SD 18) in the Oswestry Disability Index at day 154/ 5 months. The study also aims to refine MRI-assessment, investigate safety and cost-effectiveness and explore the underlying biological mechanisms of Modic changes. DISCUSSION: Finding treatments that target underlying mechanisms could pose new treatment options for patients with low back pain. Suppression of inflammation could be a treatment strategy for patients with low back pain and Modic changes. This paper presents the design of the BackToBasic study, where we will assess the effect of an anti-inflammatory treatment versus placebo in patients with chronic low back pain and type 1 Modic changes. The study is registered at ClinicalTrials.gov under the identifier NCT03704363 . The EudraCT Number: 2017-004861-29.

Indexed as

Chronic PainLow Back PainAdolescentAdultAgedHumansInfliximabLumbar VertebraeMiddle AgedMulticenter Studies as TopicNorwayPain MeasurementRandomized Controlled Trials as TopicTreatment OutcomeYoung AdultInfliximabClinical trialInflammationInfliximabLow back painModic changesRandomized controlled trialTNF- α inhibitor

Identifiers

PMID33087100
PMCPMC7580023
OpenAlexW3094289903

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.