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

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

Author information

1
Research and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital Ullevål, Pb 4950, Nydalen, 0424, Oslo, Norway. kjersti.storheim@medisin.uio.no.
2
Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.
3
Department of Clinical Medicine, University of Bergen, Pb 7804, 5020, Bergen, Norway.
4
Department of Rheumatology, Østfold Hospital Trust, Pb 300, 1714, Grålum, Norway.
5
Department of Physical Medicine and Rehabilitation, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.
6
Department of Global Public Health and Primary Care, Physiotherapy Research Group, University of Bergen, Bergen, Norway.
7
Competence Center for Clinical Research, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.
8
Department of Rehabilitation, University Hospital of North Norway, Tromsø, Norway.
9
Faculty of Health Sciences, Department of Clinical Medicine, UiT The Arctic University of Norway, Tromsø, Norway.
10
Department of Neurology, Rheumatology and Habilitation (NRH), Drammen Hospital, Vestre Viken Hospital Trust, Pb 800, 3004, Drammen, Norway.
11
Research and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital Ullevål, Pb 4950, Nydalen, 0424, Oslo, Norway.
12
Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Ulleval, Pb 4950, Nydalen, 0424, Oslo, Norway.
13
Medical Department, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway.
14
Medical Department, Stavanger University Hospital, Pb 8100, 4068, Stavanger, Norway.
15
Department of Physical Medicine and Rehabilitation, St. Olavs Hospital, Trondheim, Norway.
16
Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.
17
Department of Neurosurgery, St. Olavs University Hospital, Trondheim, Norway.
18
National Advisory Unit on Spinal Surgery, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.
19
Department of Neuroscience, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.
20
Faculty of Medicine, University of Oslo, Oslo, Norway.
21
Oslo and Akershus University College of Applied Sciences, Faculty of Health Sciences, Department of Physiotherapy, Oslo, Norway.

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.

KEYWORDS:

Antibiotics; Chronic low back pain; Modic change; Randomised controlled trial

PMID:
29246188
PMCID:
PMC5732434
DOI:
10.1186/s13063-017-2306-8
[Indexed for MEDLINE]
Free PMC Article

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