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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00302796

Enrollment

162

Registered

2006-03-15

Start date

2006-03-31

Completion date

2009-10-31

Last updated

2010-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain

Keywords

Low Back Pain,

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.

Interventions

DRUGBioclavid

500 + 125 mg times 3 or 6

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Low Back Pain Roland Morris Questionaire	One year follow-up

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026