Antibiotic Treatment to Patients With Low Back Pain

This study has been completed.
Sponsor:
Information provided by:
The Back Research Center, Denmark
ClinicalTrials.gov Identifier:
NCT00302796
First received: March 14, 2006
Last updated: May 26, 2010
Last verified: July 2009

March 14, 2006
May 26, 2010
March 2006
October 2009   (final data collection date for primary outcome measure)
Low Back Pain Roland Morris Questionaire [ Time Frame: One year follow-up ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00302796 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Back Pain
  • Drug: Bioclavid
    500 + 125 mg times 3 or 6
  • Drug: Placebo
  • Experimental: Group A, Antibiotic
    1 antibiotic tablet 45 patients Group
    Intervention: Drug: Bioclavid
  • Placebo Comparator: Group B: 1 placebo
    1 placebo tablet
    Intervention: Drug: Placebo
  • Experimental: Group C: Antibiotics
    2 antibiotic tablets 45 patients
    Intervention: Drug: Bioclavid
  • Placebo Comparator: Group D, Placebo
    2 placebo tablets 36 patients
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
October 2009
October 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00302796
2005-005500-17
Yes
Hanne Albert, The Back Research Center
The Back Research Center, Denmark
Not Provided
Principal Investigator: Hanne B Albert, Ph.D The Back Research Center, University of Southern Denmark
The Back Research Center, Denmark
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP