Overview

Antibiotic Treatment to Patients With Low Back Pain

Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Back Research Center, Denmark
Treatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Criteria
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.