Antibiotic treatment in patients with chronic low back pain and bone edema on MRI adjacent to a previously herniated disc or adjacent to a degenerated disc: a double-blind study where patients at random are offered antibiotics or placebo tablets without knowing which tablets they are given.
- Conditions
- A recent Danish study published during spring 2013 advances a remarkable cause and treatment with Amoxicillin for a selected sub-group of low back pain patients.The study was based upon a hypothesis that chronic low back pain may arise from a low-grade infection of the intervertebral disc by the anaerobic Proprione acne bacteria, resulting in pain and bone edema (Modic changes). The main scope of this RCT is to re-examine the effect of amoxicillin in this patient group.Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2013-004505-14-NO
- Lead Sponsor
- Oslo University Hospital HF, Ullevål Hospital, FORMI-Formidlingsenheten for muskel- og skjelettlidelser
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 280
Inclusion criteria will be as follows:
•Age between 18 and 65 years
•LBP of > 6 months duration in the area from L1 to L5 with a Numerical Rating Scale (NRS) score of ? 5 (mean of three NRS scales; current LBP, the worst LBP within the last 2 weeks, and usual/mean LBP within the last 2 weeks).
•MRI-confirmed disc herniation within the preceding 2 years or degenerated disc (Pfirrmann grade ? 348) at level L3/L4, L4/L5 or L5/S1.
•MC type I or type II adjacent to a previously herniated disc or adjacent to a degenerated disc (Pfirrmann grade ? 348), based on T1- and T2 weighted MRI.
•Both conservative and surgically treated patients will be included.
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 280
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Allergy to antibiotics or gradolinium contrast
•Current pregnancy or lactation
•Any kidney disease or pending litigation
•Any specific LBP diagnosis that may explain patients symptoms.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method