Study Results
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Basic Information
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COMPLETED
PHASE4
162 participants
INTERVENTIONAL
2006-03-31
2009-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Group A, Antibiotic
1 antibiotic tablet 45 patients Group
Bioclavid
500 + 125 mg times 3 or 6
Group B: 1 placebo
1 placebo tablet
Placebo
Group C: Antibiotics
2 antibiotic tablets 45 patients
Bioclavid
500 + 125 mg times 3 or 6
Group D, Placebo
2 placebo tablets 36 patients
Placebo
Interventions
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Bioclavid
500 + 125 mg times 3 or 6
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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The Back Research Center, Denmark
OTHER
Responsible Party
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The Back Research Center
Principal Investigators
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Hanne B Albert, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The Back Research Center, University of Southern Denmark
Locations
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The Back Research Center
Ringe, , Denmark
Countries
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Other Identifiers
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2005-005500-17
Identifier Type: -
Identifier Source: org_study_id
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