Antibiotic Treatment to Patients With Low Back Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Back Pain

Intervention / Treatment
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* Drug: Bioclavid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A, Antibiotic<br>1 antibiotic tablet 45 patients Group | Drug: Bioclavid<br>* 500 + 125 mg times 3 or 6<br>|
| Placebo Comparator: Group B: 1 placebo<br>1 placebo tablet | Drug: Placebo<br> <br> |
| Experimental: Group C: Antibiotics<br>2 antibiotic tablets 45 patients | Drug: Bioclavid<br>* 500 + 125 mg times 3 or 6<br>|
| Placebo Comparator: Group D, Placebo<br>2 placebo tablets 36 patients | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Back Pain Roland Morris Questionaire |  | One year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Back Pain,