Antibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial

Trials. 2017 Dec 15;18(1):596. doi: 10.1186/s13063-017-2306-8.


Background: A previous randomised controlled trial (RCT) of patients with chronic low back pain (LBP) and vertebral bone marrow (Modic) changes (MCs) on magnetic resonance imaging (MRI), reported that a 3-month, high-dose course of antibiotics had a better effect than placebo at 12 months' follow-up. The present study examines the effects of antibiotic treatment in chronic LBP patients with MCs at the level of a lumbar disc herniation, similar to the previous study. It also aims to assess the cost-effectiveness of the treatment, refine the MRI assessment of MCs, and further evaluate the impact of the treatment and the pathogenesis of MCs by studying genetic variability and the gene and protein expression of inflammatory biomarkers.

Methods/design: A double-blinded RCT is conducted at six hospitals in Norway, comparing orally administered amoxicillin 750 mg, or placebo three times a day, over a period of 100 days in patients with chronic LBP and type I or II MCs at the level of a MRI-confirmed lumbar disc herniation within the preceding 2 years. The inclusion will be stopped when at least 80 patients are included in each of the two MC type groups. In each MC type group, the study is designed to detect (β = 0.1, α = 0.05) a mean difference of 4 (standard deviation 5) in the Roland Morris Disability Questionnaire score between the two treatment groups (amoxicillin or placebo) at 1-year follow-up. The study includes cost-effectiveness measures. Blood samples are assessed for security measures and for possible inflammatory mediators and biomarkers at different time points. MCs are evaluated on MRI at baseline and after 12 months. A blinded intention-to-treat analysis of treatment effects will be performed in the total sample and in each MC type group.

Discussion: To ensure the appropriate use of antibiotic treatment, its effect in chronic LBP patients with MCs should be re-assessed. This study will investigate the effects and cost-effectiveness of amoxicillin in patients with chronic LBP and MCs at the level of a disc herniation. The study may also help to refine imaging and characterise the biomarkers of MCs.

Trial registration:, ID: NCT02323412 . Registered on 21 November 2014.

Keywords: Antibiotics; Chronic low back pain; Modic change; Randomised controlled trial.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Amoxicillin / administration & dosage*
  • Amoxicillin / adverse effects
  • Amoxicillin / economics
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / economics
  • Biomarkers / blood
  • Bone Marrow / diagnostic imaging
  • Bone Marrow / drug effects*
  • Chronic Pain / diagnostic imaging
  • Chronic Pain / drug therapy*
  • Chronic Pain / economics
  • Chronic Pain / physiopathology
  • Clinical Protocols
  • Cost-Benefit Analysis
  • Disability Evaluation
  • Double-Blind Method
  • Drug Costs
  • Female
  • Humans
  • Inflammation Mediators / blood
  • Intention to Treat Analysis
  • Intervertebral Disc Displacement / diagnostic imaging
  • Intervertebral Disc Displacement / drug therapy*
  • Intervertebral Disc Displacement / economics
  • Intervertebral Disc Displacement / physiopathology
  • Low Back Pain / diagnostic imaging
  • Low Back Pain / drug therapy*
  • Low Back Pain / economics
  • Low Back Pain / physiopathology
  • Lumbar Vertebrae / diagnostic imaging
  • Lumbar Vertebrae / drug effects*
  • Lumbar Vertebrae / physiopathology
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Norway
  • Pain Measurement
  • Research Design
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Young Adult


  • Anti-Bacterial Agents
  • Biomarkers
  • Inflammation Mediators
  • Amoxicillin

Associated data