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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014