Antibiotics In Modic Changes

Summary

Low-back pain (LBP) is the single leading cause for disability worldwide, affects all age groups and has increased from 58 million years lived with disability (YLDs) in 1990 to 83 million YLDs in 2010. The burden is accordingly substantially higher than previously assessed, causing activity limitation and work absence with subsequently enormous economic burden. Norwegian expenses reach at least NOK 24 billions annually whereof a substantial part is hospital costs. The research project responds to this challenge and aim to conduct a multicenter randomized placebo-controlled trial, complemented by a study of epigenetic and molecular biomarkers, to re-examine the finding of a recent randomized controlled trial that antibiotic treatment can cure patients with chronic low back pain (LBP), a former disc herniation and present Modic Changes (MCs). The hypothesis is that MCs is caused by low virulent anaerobic organisms in the disc. Investigators also want to add important new knowledge to the research field beyond the only former RCT by broadening the inclusion criteria to include both patients with type I and type II MCs, improving the MRI assessment of MCs, further clarifying the pathogenesis of MCs by studying genetic variability, gene and protein expression of inflammatory biomarkers, and conducting health economic analysis.

Conditions

• Low Back Pain
• Modic Changes Type I or II Seen on MRI

Interventions

DRUG

Amoxicillin (Amoksicillintrihydrat)

Amoxicillin tablets 750 mg 1x3 for 100 days (oral intake).

DRUG

Placebo

Placebo tablets 1x3 for 100 days (oral intake).

Sponsors & Collaborators

• Haukeland University Hospital

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• University Hospital of North Norway

  collaborator OTHER

• Drammen sykehus

  collaborator OTHER

• Sykehuset Ostfold

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Kjersti Storheim, PhD · Oslo University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2018-09-21

Completion

2018-11-06

Countries

• Norway

Study Locations