Link to Leaflet HERE
THE MODIC TRIAL is open for recruitment for participants with moderate to severe Chronic Low Back Pain with Modic 1 or Modic 1 and 2.
A First in Human study evaluating an intradiscal antibiotic formulation in the treatment of Chronic Low Back Pain with Modic 1 or Modic 1 and 2, THE MODIC TRIAL was set up following pioneering work by Dr Hanne Albert which demonstrated the efficacy of 100 days of oral antibiotics. The clinical evidence and associated side effects of oral antibiotic treatment was recently reviewed in The Spine Journal
THE MODIC TRIAL is a multi-centre, randomised, double-blind, placebo-controlled trial taking place in the UK, Europe and New Zealand where Regulatory and Ethics approval have been obtained.
All subjects will have Gd-enhanced MRI scans at baseline, 6 months and 12 months to assess the inflammation/Modic changes in the targeted disc. Efficacy will be assessed over 12 months using patient reported pain and disability scales.
The key inclusion criteria are:
• Aged 18-70 years
• CLBP in the area L1 to S1 associated with vertebral body endplate bone oedema (Modic 1) or vertebral body endplate bone oedema and fat (Modic 1 and 2), at a single lumbar level
• CLBP has lasted > 6 months
• Moderate-severe pain, back pain greater than leg pain
• Moderate-severe disability
• There is no clear alternative cause for back pain
• Failure of standard of care therapies
• The target lumbar disc must not have lost more than half its anticipated height at its centre
If you have any patients who are suitable and would like to take part in a clinical trial, referrals can be made to research sites in the UK:
Mr Robert Sneath
Dr Matthew Scarborough
Dr Shiva Tripathi
+44 1772 524185
THE MODIC TRIAL is sponsored by Persica Pharmaceuticals Ltd.
Further information can be found at themodictrial.com, clinicaltrials.gov and at persicapharmaceuticals.com
British Association of Spine Surgeons (BASS), RCSEng, 38-43 Lincoln's Inn Fields, Holborn, London, WC2A 3PE
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