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
  Purpose

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.


Condition Intervention Phase
Back Pain
Drug: Bioclavid
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antibiotic Treatment to Patients With Low Back Pain Associated With Modic Changes Following Disc Herniation. A Randomized Clinical Controlled Trial

Resource links provided by NLM:


Further study details as provided by The Back Research Center, Denmark:

Primary Outcome Measures:
  • Low Back Pain Roland Morris Questionaire [ Time Frame: One year follow-up ] [ Designated as safety issue: No ]

Enrollment: 162
Study Start Date: March 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A, Antibiotic
1 antibiotic tablet 45 patients Group
Drug: Bioclavid
500 + 125 mg times 3 or 6
Placebo Comparator: Group B: 1 placebo
1 placebo tablet
Drug: Placebo
Experimental: Group C: Antibiotics
2 antibiotic tablets 45 patients
Drug: Bioclavid
500 + 125 mg times 3 or 6
Placebo Comparator: Group D, Placebo
2 placebo tablets 36 patients
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302796

Locations
Denmark
The Back Research Center
Ringe, Denmark, 5230
Sponsors and Collaborators
The Back Research Center, Denmark
Investigators
Principal Investigator: Hanne B Albert, Ph.D The Back Research Center, University of Southern Denmark
  More Information

No publications provided

Responsible Party: Hanne Albert, The Back Research Center
ClinicalTrials.gov Identifier: NCT00302796     History of Changes
Other Study ID Numbers: 2005-005500-17
Study First Received: March 14, 2006
Last Updated: May 26, 2010
Health Authority: Denmark: Ethics Committee

Keywords provided by The Back Research Center, Denmark:
Low Back Pain,

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on April 16, 2014