Evidence map›Paper›PMID 32660517›Full record

Trial reportBMC musculoskeletal disorders2020

Clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes - secondary analyses of a randomised, placebo-controlled trial (the AIM study).

Lars Christian Haugli Bråten, Lars Grøvle, Ansgar Espeland, Are Hugo Pripp, Margreth Grotle, Christian Helllum, Anne Julsrud Haugen, Anne Froholdt, Mads Peder Rolfsen, Øystein Petter Nygaard and 9 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report 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 NCT02323412 (Antibiotic Treatment in Patients With Chronic Low Back Pain and Modic Changes), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.4field-weighted citation impact, top 20% 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
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Article
  3. Integrative analysis of metabolomic, genomic, and imaging-based phenotypes identify very-low-density lipoprotein as a potential risk factor for lumbar Modic changes.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
    Article
  4. Immuno-Modulatory Effects of Intervertebral Disc Cells.Frontiers in cell and developmental biology · 2022
    Review
  5. Pharmacological and non-pharmacological treatment approaches to chronic lumbar back pain.Turkish journal of physical medicine and rehabilitation · 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

19 authors at 7 institutions in 1 country.

Lars Christian Haugli BråtenFORMI, Oslo University Hospital HF, Ulleval, Bygg 37b, Postbox 4956, Nydalen, 0424, Oslo, Norway. l.c.h.braten@studmed.uio.no.ORCID http://orcid.org/0000-0002-2560-2556
Lars GrøvleDepartment of Rheumatology, Østfold Hospital Trust, PB 300, 1714, Grålum, Norway.
Ansgar EspelandDepartment of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.
Are Hugo PrippOslo Centre of Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Postbox 4950 Nydalen, 0424, Oslo, Norway.
Margreth GrotleFORMI, Oslo University Hospital HF, Ulleval, Bygg 37b, Postbox 4956, Nydalen, 0424, Oslo, Norway.
Christian HelllumDepartment of Orthopaedic surgery, Oslo University Hospital, Postbox 4956, Nydalen, 0424, Oslo, Norway.
Anne Julsrud HaugenDepartment of Rheumatology, Østfold Hospital Trust, PB 300, 1714, Grålum, Norway.
Anne FroholdtDepartment of Physical Medicine and Rehabilitation, Drammen Hospital, Vestre Viken Hospital Trust Drammen, Postboks 800, 3004, Drammen, Norway.
Mads Peder RolfsenFaculty of Medicine, University of Oslo, PO BOX 1078 Blindern, 0316, Oslo, Norway.
Øystein Petter NygaardDepartment of Neurosurgery, St. Olavs University Hospital, Postbox 3250 Torgarden, NO-7006, Trondheim, Norway.
Olav LutroStavanger University Hospital, Helse Stavanger HF, Postboks 8100, 4068, Stavanger, Norway.
Per Martin KristoffersenDepartment of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.
Audny AnkeDepartment of Rehabilitation, University Hospital of North Norway, Postboks 100, 9038, Tromsø, Norway.
Elina Iordanova SchistadDepartment of Physical Medicine and Rehabilitation, Oslo University Hospital HF, Ulleval, Postbox 4956, Nydalen, 0424, Oslo, Norway.
Jan Sture SkouenDepartment of Physical Medicine and Rehabilitation, Haukeland University Hospital, Helse Bergen HF, Box 1, Bergen, Norway.
Jens Ivar BroxFaculty of Medicine, University of Oslo, PO BOX 1078 Blindern, 0316, Oslo, Norway.
John-Anker ZwartFORMI, Oslo University Hospital HF, Ulleval, Bygg 37b, Postbox 4956, Nydalen, 0424, Oslo, Norway.
Kjersti StorheimFORMI, Oslo University Hospital HF, Ulleval, Bygg 37b, Postbox 4956, Nydalen, 0424, Oslo, Norway.
AIM-study group
Oslo University Hospital · NOHaukeland University Hospital · NOØstfold Hospital Trust · NODrammen Hospital · NONorwegian University of Science and Technology · NOStavanger University Hospital · NOUniversity Hospital of North Norway · NO

Funding

Helse Sør-Øst RHF No 2015090Helse Vest No 911891Helse Vest No 911938
6 · The paper itself

Abstract

backgroundRandomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation.

methodsWe performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0-24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms.

resultsNone of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was - 4.0 (95%CI, - 6.9 to - 1.2), compared to - 0.5 (95%CI, - 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis).

conclusionsWe did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies.

trial registrationClinicalTrials.gov NCT02323412 , First registered 23 December 2014.

Indexed as

Low Back PainAdministration, OralAnti-Bacterial AgentsHumansIntentionLumbar VertebraeMaleTreatment OutcomeAnti-Bacterial AgentsAntibioticChronic low back painEffect modifierInfectionModic changesRandomisedSubgroup

Identifiers

PMID32660517
PMCPMC7359501
OpenAlexW3041902493

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.