Antibiotic Treatment to Patients With Low Back Pain

NCT00302796 | Completed Phase 4 DMC

• 1 other identifier: 2005-005500-17
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Back Pain

Keywords

Low Back Pain,

Outcome Measures

Primary Outcomes (1)

• Low Back Pain Roland Morris Questionaire

  One year follow-up

Study Arms (4)

Group A, Antibiotic

EXPERIMENTAL

1 antibiotic tablet 45 patients Group

Drug: Bioclavid

Group B: 1 placebo

PLACEBO COMPARATOR

1 placebo tablet

Drug: Placebo

Group C: Antibiotics

EXPERIMENTAL

2 antibiotic tablets 45 patients

Drug: Bioclavid

Group D, Placebo

PLACEBO COMPARATOR

2 placebo tablets 36 patients

Drug: Placebo

Interventions

Bioclavid DRUG

500 + 125 mg times 3 or 6

Group A, Antibiotic; Group C: Antibiotics

Placebo DRUG

Group B: 1 placebo; Group D, Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Back Research Center, Denmark: lead

Study Sites (1)

The Back Research Center

Ringe, 5230, Denmark

Location

MeSH Terms

Conditions

Back Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hanne B Albert, Ph.D

  The Back Research Center, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 14, 2006
• First Posted: March 15, 2006
• Study Start: March 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 27, 2010

Record last verified: 2009-07

Locations

DK (1)