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This study evaluated the antibiotic Amoxicillin compared with placebo in patients with long-lasting low back pain who have Modic changes in the lumbar vertebrae. It included patients aged 18 to 65 with a history of MRI-confirmed disc herniation and back pain lasting more than six months. It was conducted in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Patients from all health regions in Norway referred to the participating hospitals will be screened for eligibility. Both conservatively and surgically treated patients (i.e. operated on for disc herniation \> 12 months prior to inclusion) will be included. In addition, patients registered in the Norwegian Registry for Spine Surgery operated on for disc herniation and reporting severe LBP pain at one-year follow-up in the registry, will be invited. Inclusion Criteria * Age between 18 and 65 years * LBP of \> 6 months duration in the area below the 12th rib and above the gluteal folds with a Numerical Rating Scale (NRS) pain intensity score of ³ 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 lumbar disc herniation within the preceding 2 years. * MC type I and/or type II in the vertebral body marrow at the same level as the previously herniated disc. For patients with former surgery for disc herniation, the MC has to be located at an operated level. * Written informed consent Exclusion Criteria: * Allergy to penicillin or cefalosporins * Allergy/hypersensitivity to any of the excipients of the study drug * Current pregnancy or lactation * Elevated kidney (creatinine) or hepatic (ALAT/ASAT) values outside normal range * Phenylketonuria (Følling disease) * Mononucleosis or leukaemia * Any specific diagnosis that may explain patient's low back symptoms (e.g. tumor, fracture, spondyloarthritis, infection, spinal stenosis). * Former low back surgery (L1 - S1) for other reasons than disc herniation (e.g fusion, decompression, disc prosthesis). * Former surgery for disc herniation, but \< 12 months have elapsed since surgery. * Former surgery for disc herniation, but MC located at non-operated level(s) only. * Reservation against intake of gelatine (the capsules contains gelatine, which among other things is produced by ingredients from pigs) * Regular use of glucocorticoids * Regular use of opioids with the exception of codeine and tramadol * Not understanding Norwegian language * Unlikely to adhere to treatment and/ or complete follow-up (e.g ongoing serious psychiatric disease, drug abuse, plans to move) * Antibiotic treatment within the preceding one month before treatment start * Contraindications to MRI (e.g. cardiac pacemaker electrodes, metal implant in eye or brain, claustrophobia). * Unwilling to participate