Antibiotic Treatment to Patients With Low Back Pain Associated With Modic Changes Following Disc Herniation. A Randomized Clinical Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Bioclavid
- Conditions
- Back Pain
- Sponsor
- The Back Research Center, Denmark
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- Low Back Pain Roland Morris Questionaire
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
Group A, Antibiotic
1 antibiotic tablet 45 patients Group
Intervention: Bioclavid
Group B: 1 placebo
1 placebo tablet
Intervention: Placebo
Group C: Antibiotics
2 antibiotic tablets 45 patients
Intervention: Bioclavid
Group D, Placebo
2 placebo tablets 36 patients
Intervention: Placebo
Outcomes
Primary Outcomes
Low Back Pain Roland Morris Questionaire
Time Frame: One year follow-up