Antibiotic Treatment to Patients With Low Back Pain

This study has been completed.

Sponsor:

Information provided by:

The Back Research Center, Denmark

ClinicalTrials.gov Identifier:

NCT00302796

First received: March 14, 2006

Last updated: May 26, 2010

Last verified: July 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 14, 2006

Last Updated Date

May 26, 2010

Start Date ^ICMJE

March 2006

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Low Back Pain Roland Morris Questionaire [ Time Frame: One year follow-up ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00302796 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Antibiotic Treatment to Patients With Low Back Pain

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Back Pain

Intervention ^ICMJE

Drug: Bioclavid
500 + 125 mg times 3 or 6
Drug: Placebo

Study Arm (s)

Experimental: Group A, Antibiotic
1 antibiotic tablet 45 patients Group

Intervention: Drug: Bioclavid
Placebo Comparator: Group B: 1 placebo
1 placebo tablet

Intervention: Drug: Placebo
Experimental: Group C: Antibiotics
2 antibiotic tablets 45 patients

Intervention: Drug: Bioclavid
Placebo Comparator: Group D, Placebo
2 placebo tablets 36 patients

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

162

Completion Date

October 2009

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00302796

Other Study ID Numbers ^ICMJE

2005-005500-17

Has Data Monitoring Committee

Yes

Responsible Party

Hanne Albert, The Back Research Center

Study Sponsor ^ICMJE

The Back Research Center, Denmark

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Hanne B Albert, Ph.D

The Back Research Center, University of Southern Denmark

Information Provided By

The Back Research Center, Denmark

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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