Antibiotic treatment of patients with low back pain and Modic changes after a lumbar disc herniation. A randomized clinical controlled trial.
- Conditions
- ow back pain wiht Modic changes identified on MRI
- Registration Number
- EUCTR2005-005500-17-DK
- Lead Sponsor
- The Back Research center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 162
Age between 18-65 years
Previous herniated disc confirmed by MRI
Time span since lumbar disc herniation more than 6 months and less than 2 years.
Lumbar pain in the area of L1 to L5 on the added Low Back Pain Rating scale >6
The investigatory MRI shows present Modic changes
Positive springing test (SPT) at the level of the Modic changes
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Allergy to antibiotic
The Beck Depression Inventory <7
Pregnancy
Breast feeding
Any kidney disease including Føllings disease
Pending workers compensation litigation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of this study is to evaluate the efficacy of antibiotic treatment to patients with Low Back Pain and Modic changes after a lumbar disc herniation, and to evaluate if there is a dose-response relationship in different doses of antibiotics.;Secondary Objective: ;Primary end point(s): Roland Morris Questionnaire (RMQ) <br>Modified Patient Specific Function Scale <br>Low Back Pain Rating Scale (RS) <br>
- Secondary Outcome Measures
Name Time Method