Evidence map›Paper›PMID 31619437›Full record

Trial reportBMJ (Clinical research ed.)2019

Efficacy of antibiotic treatment in patients with chronic low back pain and Modic changes (the AIM study): double blind, randomised, placebo controlled, multicentre trial.

Lars Christian Haugli Bråten, Mads Peder Rolfsen, Ansgar Espeland, Monica Wigemyr, Jörg Aßmus, Anne Froholdt, Anne Julsrud Haugen, Gunn Hege Marchand, Per Martin Kristoffersen, Olav Lutro and 19 more

Erratum issued 3 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2019. 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 3 registered trials, which are not on this map. Cited by 66 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 2 pooled it
10.3field-weighted citation impact, top 1% 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.

NCT02323412 phase3completednot on this map

Antibiotic Treatment in Patients With Chronic Low Back Pain and Modic Changes: a Randomized Double-blind Placebo Controlled Trial

TypeinterventionalSponsorOslo University HospitalRan2015 to 2018Enrolled180ConditionsLow Back Pain, Modic Changes Type I or II Seen on MRIArmsAmoxicillin (Amoksicillintrihydrat), Placebo
NCT06169488 narecruitingnot on this mapstarted 2024, after this paper: background citation

The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial

TypeinterventionalSponsorOslo University HospitalRan2024 to 2030Enrolled202ConditionsChronic Low-back PainArmsLumbar Interbody Fusion, Multidisciplinary rehabilitation
NCT06771492 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial

TypeinterventionalSponsorBart KoesRan2025 to 2027Enrolled204ConditionsMSK Conditions, Chronic Low Back Pain (CLBP), Modic ChangesArmsAmoxicillin, Placebo
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 2 syntheses or guidelines pooled it, 114 citations in OpenAlex.

  1. Pooled it
  2. Evidence for infection in intervertebral disc degeneration: a systematic review.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 · 2022
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. IntradiscalJOR spine · 2026
    Article
  11. Article
  12. Review
  13. Article
  14. Flow Cytometry Study of Immune Cell Subpopulations from the Mouse Vertebral Bone Marrow and Intervertebral Disc Following Endplate Microfracture.Biocell : official journal of the Sociedades Latinoamericanas de Microscopia Electronica ... et. al · 2026
    Article
  15. Review
  16. Review
  17. 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
  18. Article
  19. 14. Discogenic Low Back Pain.Pain practice : the official journal of World Institute of Pain · 2025
    Review
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 8 institutions in 1 country.

Lars Christian Haugli BråtenResearch and Communication Unit for Musculoskeletal Health(FORMI), Oslo University Hospital HF, Oslo, Norway l.c.h.braten@studmed.uio.no.ORCID 0000-0002-2560-2556
Mads Peder RolfsenFaculty of Medicine, University of Oslo, Oslo, Norway.
Ansgar EspelandDepartment of Radiology, Haukeland University Hospital, Bergen, Norway.
Monica WigemyrResearch and Communication Unit for Musculoskeletal Health(FORMI), Oslo University Hospital HF, Oslo, Norway.
Jörg AßmusCentre for Clinical Research, Haukeland University Hospital, Bergen, Norway.
Anne FroholdtDepartment of Physical Medicine and Rehabilitation, Drammen Hospital, Drammen, Norway.
Anne Julsrud HaugenDepartment of Rheumatology, Østfold Hospital Trust, Grålum, Norway.
Gunn Hege MarchandDepartment of Physical Medicine and Rehabilitation, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
Per Martin KristoffersenDepartment of Radiology, Haukeland University Hospital, Bergen, Norway.
Olav LutroStavanger University Hospital, Stavanger, Norway.
Sigrun RandenDepartment of Physical Medicine and Rehabilitation, Drammen Hospital, Drammen, Norway.
Maja WilhelmsenDepartment of Rehabilitation, University Hospital of North Norway, Tromsø, Norway.
Bendik Slagsvold WinsvoldDepartment of Research, Innovation and Education, Division of Clinical Neuroscience, Oslo University Hospital, Oslo, Norway.
Thomas Istvan KadarDepartment of Physical Medicine and Rehabilitation, Haukeland University Hospital, Bergen, Norway.
Thor Einar HolmgardNorwegian Back Pain Association, Drammen, Norway.
Maria Dehli VigelandResearch and Communication Unit for Musculoskeletal Health(FORMI), Oslo University Hospital HF, Oslo, Norway.
Nils VettiDepartment of Radiology, Haukeland University Hospital, Bergen, Norway.
Øystein Petter NygaardDepartment of Neurosurgery, St Olavs University Hospital, Trondheim, Norway.
Benedicte Alexandra LieDepartment of Medical Genetics, University of Oslo and Oslo University Hospital, Oslo, Norway.
Christian HellumDepartment of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.
Audny AnkeDepartment of Rehabilitation, University Hospital of North Norway, Tromsø, Norway.
Margreth GrotleResearch and Communication Unit for Musculoskeletal Health(FORMI), Oslo University Hospital HF, Oslo, Norway.
Elina Iordanova SchistadDepartment of Physical Medicine and Rehabilitation, Oslo University Hospital HF, Oslo, Norway.
Jan Sture SkouenDepartment of Physical Medicine and Rehabilitation, Haukeland University Hospital, Bergen, Norway.
Lars GrøvleDepartment of Rheumatology, Østfold Hospital Trust, Grålum, Norway.
Jens Ivar BroxFaculty of Medicine, University of Oslo, Oslo, Norway.
John-Anker ZwartResearch and Communication Unit for Musculoskeletal Health(FORMI), Oslo University Hospital HF, Oslo, Norway.
Kjersti StorheimResearch and Communication Unit for Musculoskeletal Health(FORMI), Oslo University Hospital HF, Oslo, Norway.
AIM study group
Oslo University Hospital · NOHaukeland University Hospital · NODrammen Hospital · NONorwegian University of Science and Technology · NOØstfold Hospital Trust · NOUniversity Hospital of North Norway · NONorwegian Medical Association · NOStavanger University Hospital · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the efficacy of three months of antibiotic treatment compared with placebo in patients with chronic low back pain, previous disc herniation, and vertebral endplate changes (Modic changes).

designDouble blind, parallel group, placebo controlled, multicentre trial.

settingHospital outpatient clinics at six hospitals in Norway.

participants180 patients with chronic low back pain, previous disc herniation, and type 1 (n=118) or type 2 (n=62) Modic changes enrolled from June 2015 to September 2017.

interventionsPatients were randomised to three months of oral treatment with either 750 mg amoxicillin or placebo three times daily. The allocation sequence was concealed by using a computer generated number on the prescription.

main outcome measuresThe primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (range 0-24) at one year follow-up in the intention to treat population. The minimal clinically important between group difference in mean RMDQ score was predefined as 4.

resultsIn the primary analysis of the total cohort at one year, the difference in the mean RMDQ score between the amoxicillin group and the placebo group was -1.6 (95% confidence interval -3.1 to 0.0, P=0.04). In the secondary analysis, the difference in the mean RMDQ score between the groups was -2.3 (-4.2 to-0.4, P=0.02) for patients with type 1 Modic changes and -0.1 (-2.7 to 2.6, P=0.95) for patients with type 2 Modic changes. Fifty patients (56%) in the amoxicillin group experienced at least one drug related adverse event compared with 31 (34%) in the placebo group.

conclusionsIn this study on patients with chronic low back pain and Modic changes at the level of a previous disc herniation, three months of treatment with amoxicillin did not provide a clinically important benefit compared with placebo. Secondary analyses and sensitivity analyses supported this finding. Therefore, our results do not support the use of antibiotic treatment for chronic low back pain and Modic changes.

trial registrationClinicalTrials.gov NCT02323412.

Indexed as

AmoxicillinLow Back PainLumbar VertebraeAdultAnti-Bacterial AgentsChronic PainDisability EvaluationDouble-Blind MethodFemaleHumansIntervertebral Disc DegenerationIntervertebral Disc DisplacementMaleMiddle AgedNorwayPain MeasurementAmoxicillinAnti-Bacterial Agents

Identifiers

PMID31619437
PMCPMC6812614
OpenAlexW2980892253

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.