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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A, Antibiotic | Experimental | 1 antibiotic tablet 45 patients Group |
|
| Group B: 1 placebo | Placebo Comparator | 1 placebo tablet |
|
| Group C: Antibiotics | Experimental | 2 antibiotic tablets 45 patients |
|
| Group D, Placebo | Placebo Comparator | 2 placebo tablets 36 patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioclavid | Drug | 500 + 125 mg times 3 or 6 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Low Back Pain Roland Morris Questionaire | One year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanne B Albert, Ph.D | The Back Research Center, University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Back Research Center | Ringe | 5230 | Denmark |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo |
| Drug |
|