Trial | NCT00302796  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    162
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.
Study Started
Mar 31
2006
Primary Completion
Oct 31
2009
Study Completion
Oct 31
2009
Last Update
May 27
2010
Estimate

Drug Bioclavid

500 + 125 mg times 3 or 6

Drug Placebo

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

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.
No Results Posted