Antibiotic Treatment to Patients With Low Back Pain

Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302796
• Other study ID #: 2005-005500-17
• Status: Completed
• Phase: Phase 4
• First received: March 14, 2006
• Last updated: May 26, 2010
• Start date: March 2006
• Est. completion date: October 2009

Study information

• Verified date: July 2009
• Source: The Back Research Center, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Bioclavid
500 + 125 mg times 3 or 6
• Placebo

Locations

Country	Name	City	State
Denmark	The Back Research Center	Ringe

Sponsors (1)

Lead Sponsor	Collaborator
The Back Research Center, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low Back Pain Roland Morris Questionaire		One year follow-up	No