Abstract

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

ClinicalTrials.gov, ID: NCT02323412. Registered on 21 November 2014.

Details

Title
Antibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial
Author
Storheim, Kjersti 1   VIAFID ORCID Logo  ; Espeland, Ansgar 2 ; Grøvle, Lars 3 ; Skouen, Jan Sture 4 ; Aßmus, Jörg 5 ; Anke, Audny 6 ; Froholdt, Anne 7 ; Pedersen, Linda M. 1 ; Haugen, Anne Julsrud 3 ; Fors, Terese 8 ; Schistad, Elina 9 ; Lutro, Olav 10 ; Marchand, Gunn Hege 11 ; Kadar, Thomas 12 ; Vetti, Nils 2 ; Randen, Sigrun 7 ; Nygaard, Øystein Petter 13 ; Brox, Jens Ivar 14 ; Grotle, Margreth 15 ; Zwart, John-Anker 16 

1  Oslo University Hospital Ullevål, Research and Communication Unit for Musculoskeletal Health (FORMI), Oslo, Norway (GRID:grid.55325.34) (ISNI:0000 0004 0389 8485) 
2  Haukeland University Hospital, Department of Radiology, Bergen, Norway (GRID:grid.412008.f) (ISNI:0000 0000 9753 1393); University of Bergen, Department of Clinical Medicine, Bergen, Norway (GRID:grid.7914.b) (ISNI:0000 0004 1936 7443) 
3  Østfold Hospital Trust, Department of Rheumatology, Grålum, Norway (GRID:grid.412938.5) 
4  Haukeland University Hospital, Department of Physical Medicine and Rehabilitation, Bergen, Norway (GRID:grid.412008.f) (ISNI:0000 0000 9753 1393); University of Bergen, Department of Global Public Health and Primary Care, Physiotherapy Research Group, Bergen, Norway (GRID:grid.7914.b) (ISNI:0000 0004 1936 7443) 
5  Competence Center for Clinical Research, Haukeland University Hospital, Bergen, Norway (GRID:grid.412008.f) (ISNI:0000 0000 9753 1393) 
6  University Hospital of North Norway, Department of Rehabilitation, Tromsø, Norway (GRID:grid.412244.5) (ISNI:0000 0004 4689 5540); UiT The Arctic University of Norway, Faculty of Health Sciences, Department of Clinical Medicine, Tromsø, Norway (GRID:grid.10919.30) (ISNI:0000000122595234) 
7  Drammen Hospital, Vestre Viken Hospital Trust, Department of Neurology, Rheumatology and Habilitation (NRH), Drammen, Norway (GRID:grid.470118.b) (ISNI:0000 0004 0627 3835) 
8  University Hospital of North Norway, Department of Rehabilitation, Tromsø, Norway (GRID:grid.412244.5) (ISNI:0000 0004 4689 5540) 
9  Oslo University Hospital, Ulleval, Department of Physical Medicine and Rehabilitation, Oslo, Norway (GRID:grid.55325.34) (ISNI:0000 0004 0389 8485) 
10  Haukeland University Hospital, Medical Department, Bergen, Norway (GRID:grid.412008.f) (ISNI:0000 0000 9753 1393); Stavanger University Hospital, Medical Department, Stavanger, Norway (GRID:grid.412835.9) (ISNI:0000 0004 0627 2891) 
11  St. Olavs Hospital, Department of Physical Medicine and Rehabilitation, Trondheim, Norway (GRID:grid.52522.32) (ISNI:0000 0004 0627 3560); Norwegian University of Science and Technology (NTNU), Department of Neuromedicine and Movement Science, Trondheim, Norway (GRID:grid.5947.f) (ISNI:0000 0001 1516 2393) 
12  Haukeland University Hospital, Department of Physical Medicine and Rehabilitation, Bergen, Norway (GRID:grid.412008.f) (ISNI:0000 0000 9753 1393) 
13  St. Olavs University Hospital, Department of Neurosurgery, Trondheim, Norway (GRID:grid.52522.32) (ISNI:0000 0004 0627 3560); National Advisory Unit on Spinal Surgery, Norwegian University of Science and Technology (NTNU), Trondheim, Norway (GRID:grid.5947.f) (ISNI:0000 0001 1516 2393); Norwegian University of Science and Technology (NTNU), Department of Neuroscience, Trondheim, Norway (GRID:grid.5947.f) (ISNI:0000 0001 1516 2393) 
14  Oslo University Hospital, Ulleval, Department of Physical Medicine and Rehabilitation, Oslo, Norway (GRID:grid.55325.34) (ISNI:0000 0004 0389 8485); Faculty of Medicine, University of Oslo, Oslo, Norway (GRID:grid.5510.1) (ISNI:0000 0004 1936 8921) 
15  Oslo University Hospital Ullevål, Research and Communication Unit for Musculoskeletal Health (FORMI), Oslo, Norway (GRID:grid.55325.34) (ISNI:0000 0004 0389 8485); Oslo and Akershus University College of Applied Sciences, Faculty of Health Sciences, Department of Physiotherapy, Oslo, Norway (GRID:grid.412414.6) (ISNI:0000 0000 9151 4445) 
16  Oslo University Hospital Ullevål, Research and Communication Unit for Musculoskeletal Health (FORMI), Oslo, Norway (GRID:grid.55325.34) (ISNI:0000 0004 0389 8485); Faculty of Medicine, University of Oslo, Oslo, Norway (GRID:grid.5510.1) (ISNI:0000 0004 1936 8921) 
Pages
596
Publication year
2017
Publication date
Dec 2017
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-017-2306-8
ProQuest document ID
2795252713
Copyright
© The Author(s). 2017. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.