Antibiotic Treatment to Patients With Low Back Pain

A large proportion of patients with Low Back Pain (LBP) (80 %) are classified as "non-specific", due to the lack of a patho-anatomical diagnosis. This term is not satisfactory, since it implies uncertainty for both the patient and the clinician. Modic changes have recently been identified as a pain giving patho-anatomical diagnosis for a considerable percentage (20-30 %) of LBP patients. The causes of these Modic changes have not been determined conclusively but bacterial infection is among the plausible causes for those following a disc herniation.

Purpose The aim of this study is to assess the clinical effect of antibiotic treatment compared to placebo, in patients with LBP and Modic changes following a lumbar herniated disc.

Design A double blind prospective clinically controlled trial. Patients will be randomized by a blinded observer to either Group A: 1 antibiotic tablet 45 patients Group B: 1 placebo tablet 36 patients Group C: 2 antibiotic tablets 45 patients Group D: 2 placebo tablets 36 patients

The patients will take the drug three times a day for 100 days.

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Key information

Conditions

Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Back Research Center

Ringe, 5230, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age between 18-65 years
Previous lumbar herniated disc confirmed by MRI
Time since lumbar disc herniation more than 6 months less than 2 years
LBP in the area of L1 to L5, with an added Low Back Pain Rating Scale of 6 or more
The present MRI shows Modic changes
Positive Springing test (SPT) at the level of Modic changes

Exclusion criteria

Allergy against antibiotics
The Beck Depression Inventory >7,
Pregnancy
Breast feeding
All Kidney diseases
Pending workers litigation or pension
Danish as second language
Fertile women who do not user safe anti conseption
Reduced liver functions
Reduced liver function due to previous treatment wiht amoxicillin/clavulanasid.

Treatment and study plan

Bioclavid

Drug

500 + 125 mg times 3 or 6

Placebo

Drug

Primary outcomes

Low Back Pain Roland Morris Questionaire

Time frame: One year follow-up

Sponsors and collaborators

Lead sponsor

The Back Research Center, Denmark

Other

Registry information

Official study title

Antibiotic Treatment to Patients With Low Back Pain Associated With Modic Changes Following Disc Herniation. A Randomized Clinical Controlled Trial

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Mar 15, 2006
Registry last updated: May 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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