None listed
Conditions
Brief summary
Low back pain is a major public health problem in Australia, ranking 2nd only to cancer as the leading cause of disability. While its prevalence is high, with 80% of Australians experiencing low back pain during their lifetime, effective treatments are limited. In 2013 a study was published which showed that antibiotics were effective in treating a specific type of low back pain involving injury to the disc and oedema of the bone. The trial was based on the hypothesis that following a disc injury (experienced as acute back pain) a secondary infection develops in the disc which leads to a chronic, disabling condition. There has been both immense interest and controversy regarding this trial. While leading, international surgeons suggest that it should be nominated for a Nobel prize, others have called for further research. To date the results of the trial have not been translated into clinical practice, as there are unanswered questions regarding the approach. The specific group of patients who need to be targeted is unclear, the effectiveness of this treatment in conjunction with standard care is unknown, and the costs and associated resistance to the antibiotic therapy has not been investigated. We aim to perform a clinical trial to investigate the effectiveness of antibiotic treatment in a broader group of individuals with chronic low back pain and a disc injury, to determine whether specific Magnetic Resonance Imaging (MRI) changes predict response to this approach, and to examine the cost-effectiveness and antibiotic resistance of this therapy. If antibiotics are found to be a cost-effective and safe treatment for some patients with chronic low back pain, this will provide a novel approach for the prevention of long term pain and disability in these individuals.
Interventions
Antibiotic: Amoxycillin clavulanic acid (500/125mg), 1 tablet twice a day for 90 days.
Adherence: Return of unused medication or empty bottles
MRI scans: Two lumbar spine MRI scans will be performed. The first is a screening MRI to determine the presence of lumbar disc herniation and the second is a followup MRI at 12 months. Both MRIs will allow the presence of modic changes to be examined. The MRI scans will performed at Melbourne-based imaging clinics by experienced radiographers/MRI specia
Antibiotic: Amoxycillin clavulanic acid (500/125mg), 1 tablet twice a day for 90 days. Adherence: Return of unused medication or empty bottles MRI scans: Two lumbar spine MRI scans will be performed. The first is a screening MRI to determine the presence of lumbar disc herniation and the second is a followup MRI at 12 months. Both MRIs will allow the presence of modic changes to be examined. The MRI scans will performed at Melbourne-based imaging clinics by experienced radiographers/MRI specialists. Participants will be positioned in supine on a plinth which will retract into a cylindrical MRI scanner. The scans will take approximately 40 mins each.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1 Chronic low back pain (Chronic > 3 months in duration; pain in the region bordered above by the 12th ribs and below by the gluteal folds) 2. Aged 18-60 years 3. Presence of a lumbar disc herniation on MRI
Exclusion criteria
Specific pathological entities, such as metastasis and osteoporosis; any contra-indication or allergy to antibiotics; antibiotic therapy in the past 3 months; immuno-compromised; osteomyelitis; current pregnancy or lactation; any liver or kidney disease; candidate for spinal surgery; major co-existing illness which may confound assessment of function; inability to provide consent.
Outcome results
None listed