Antibiotics In Modic Changes

• Status: Completed
• Trial end date: 2018-11-06
• Target enrollment: 0
• Participant gender: All

Summary

Low-back pain (LBP) is the single leading cause for disability worldwide, affects all age groups and has increased from 58 million years lived with disability (YLDs) in 1990 to 83 million YLDs in 2010. The burden is accordingly substantially higher than previously assessed, causing activity limitation and work absence with subsequently enormous economic burden. Norwegian expenses reach at least NOK 24 billions annually whereof a substantial part is hospital costs. The research project responds to this challenge and aim to conduct a multicenter randomized placebo-controlled trial, complemented by a study of epigenetic and molecular biomarkers, to re-examine the finding of a recent randomized controlled trial that antibiotic treatment can cure patients with chronic low back pain (LBP), a former disc herniation and present Modic Changes (MCs). The hypothesis is that MCs is caused by low virulent anaerobic organisms in the disc. Investigators also want to add important new knowledge to the research field beyond the only former RCT by broadening the inclusion criteria to include both patients with type I and type II MCs, improving the MRI assessment of MCs, further clarifying the pathogenesis of MCs by studying genetic variability, gene and protein expression of inflammatory biomarkers, and conducting health economic analysis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborators: Drammen sykehus; Haukeland University Hospital; St. Olavs Hospital; Sykehuset Ostfold; University Hospital of North Norway
• Treatments: Amoxicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular

Criteria

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