Trial reportEuropean radiology2021
Oedema on STIR modified the effect of amoxicillin as treatment for chronic low back pain with Modic changes-subgroup analysis of a randomized trial.
Trial report in European radiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
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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.
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.
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Who cites it
12 citing papers in PubMed, 23 citations in OpenAlex.
- Cytokine Patterns as Predictors of Antibiotic Treatment Effect in Chronic Low Back Pain with Modic Changes: Subgroup Analyses of a Randomized Trial (AIM Study).Journal of pain research · 2023Trial
- Modic changes and their role in vertebrogenic back pain: a literature review.Skeletal radiology · 2026Review
- Preclinical development and characterisation of PP353, a formulation of linezolid for intradiscal administration.JOR spine · 2024Article
- Bacterial growth in patients with low back pain and Modic changes: protocol of a multicentre, case-control biopsy study.BMJ open · 2024Article
- The Clinical Significance of the Modic Changes Grading Score.Global spine journal · 2024Article
- Efficacy of stepped care treatment for chronic discogenic low back pain patients with Modic I and II changes.Interventional pain medicine · 2023Article
- Modic changes as seen on MRI are associated with nonspecific chronic lower back pain and disability.Journal of orthopaedic surgery and research · 2023Review
- Intradiscal pharmacokinetics of oral antibiotics to treat Chronic Lower Back Pain.npj antimicrobials and resistance · 2023Review
- Vertebrogenic Pain: A Paradigm Shift in Diagnosis and Treatment of Axial Low Back Pain.Pain medicine (Malden, Mass.) · 2022Article
- Correlation between gene expression and MRI STIR signals in patients with chronic low back pain and Modic changes indicates immune involvement.Scientific reports · 2022Article
- Chronic low back pain, Modic changes and low-grade virulent infection: efficacy of antibiotic treatment.Future science OA · 2021Review
- Antibiotics should not be used for back/leg pain.Acta orthopaedica · 2021Article
Corrections and comments
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Authors and funding
9 authors at 3 institutions in 2 countries.
Funding
Abstract
objectiveTo evaluate potential MRI-defined effect modifiers of amoxicillin treatment in patients with chronic low back pain and type 1 or 2 Modic changes (MCs) at the level of a previous lumbar disc herniation (index level).
methodsIn a prospective trial (AIM), 180 patients (25-64 years; mean age 45; 105 women) were randomised to receive amoxicillin or placebo for 3 months. Primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (0-24 scale) at 1 year. Mean RMDQ score difference between the groups at 1 year defined the treatment effect; 4 RMDQ points defined the minimal clinically important effect. Predefined baseline MRI features of MCs at the index level(s) were investigated as potential effect modifiers. The predefined primary hypothesis was a better effect of amoxicillin when short tau inversion recovery (STIR) shows more MC-related high signal. To evaluate this hypothesis, we pre-constructed a composite variable with three categories (STIR1/2/3). STIR3 implied MC-related STIR signal increases with volume ≥ 25% and height > 50% of vertebral body and maximum intensity increase ≥ 25% and presence on both sides of the disc. As pre-planned, interaction with treatment was analysed using ANCOVA in the per protocol population (n = 155).
resultsThe STIR3 composite group (n = 41) and STIR signal volume ≥ 25% alone (n = 45) modified the treatment effect of amoxicillin. As hypothesised, STIR3 patients reported the largest effect (- 5.1 RMDQ points; 95% CI - 8.2 to - 1.9; p for interaction = 0.008).
conclusionsPredefined subgroups with abundant MC-related index-level oedema on STIR modified the effect of amoxicillin. This finding needs replication and further support. KEY POINTS: • In the primary analysis of the AIM trial, the effect of amoxicillin in patients with chronic low back pain and type 1 or 2 MCs did not reach the predefined cut-off for clinical importance. • In the present MRI subgroup analysis of AIM, predefined subgroups with abundant MC-related oedema on STIR reported an effect of amoxicillin. • This finding requires replication and further support.
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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.