Antibiotic Treatment to Patients With Low Back Pain

Phase 4

Completed

• Conditions: Back Pain
• Interventions: Drug: Bioclavid; Drug: Placebo

• Registration Number: NCT00302796
• Lead Sponsor: The Back Research Center, Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-14
• Study First Submitted QC: 2006-03-14
• Study First Posted: 2006-03-15
• Status Verified: 2009-07
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2010-05-26
• Last Update Posted: 2010-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A, Antibiotic	Bioclavid	1 antibiotic tablet 45 patients Group
Group B: 1 placebo	Placebo	1 placebo tablet
Group C: Antibiotics	Bioclavid	2 antibiotic tablets 45 patients
Group D, Placebo	Placebo	2 placebo tablets 36 patients

Primary Outcome Measures

Name	Time	Method
Low Back Pain Roland Morris Questionaire	One year follow-up

Trial Locations

Locations (1)

The Back Research Center; 🇩🇰 Ringe, Denmark