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Efficacy of antibiotic treatment for patients with chronic low back pain
EU CTIS ID: 2024-515824-35-01
What this study is testing
To assess the efficacy of three months antibiotic treatment with amoxicillin compared to placebo for patients with chronic LBP and Modic type I changes on MRI.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged 18-65 years.
- Chronic low back pain (i.e. duration >6 months) after a previous (MRI confirmed) disc herniation within the past 6 months to 2 years.
- At least 2 of the following questions should be answered with “Yes”: Does training and/or exercise increase your pain? Is your sleep during the night disturbed due to your back pain? Is it painful to turn over in bed at night? Do you suffer from morning pain?
- The mean pain intensity should be at least 5 points on a 0-10 NRS-scale, calculated as the mean pain intensity of 3 indices: current pain, worst pain within the preceding two weeks, and the usual mean pain within the preceding two weeks.
- Modic Type I changes visible on the MRI-scan in the vertebrae adjacent to the previous herniated disc.
You likely can't join if
- Received antibiotic treatment in the past month.
- Hepatic or renal (eGFR≤30) impairment.
- Current pregnancy, lactation or pregnancy-wish.
- Severe physical or psychiatric co-morbidities.
- LBP resulting from a specific cause such as a tumor or fracture.
- Surgery or epidural injection in the past 6 months.
See the full eligibility criteria
- Aged 18-65 years.
- Chronic low back pain (i.e. duration >6 months) after a previous (MRI confirmed) disc herniation within the past 6 months to 2 years.
- At least 2 of the following questions should be answered with “Yes”: Does training and/or exercise increase your pain? Is your sleep during the night disturbed due to your back pain? Is it painful to turn over in bed at night? Do you suffer from morning pain?
- The mean pain intensity should be at least 5 points on a 0-10 NRS-scale, calculated as the mean pain intensity of 3 indices: current pain, worst pain within the preceding two weeks, and the usual mean pain within the preceding two weeks.
- Modic Type I changes visible on the MRI-scan in the vertebrae adjacent to the previous herniated disc.
- Received antibiotic treatment in the past month.
- Hepatic or renal (eGFR≤30) impairment.
- Current pregnancy, lactation or pregnancy-wish.
- Severe physical or psychiatric co-morbidities.
- LBP resulting from a specific cause such as a tumor or fracture.
- Surgery or epidural injection in the past 6 months.
- Previous antibiotic course of 100 days.
- Contra-indication for amoxicillin use: allergy to penicillins/amoxicillin, cephalosporin or carbapenem; mononucleosis; leukemia; phenylketonuria (PKU).
- Contra-indication for MRI.
- Current use of any of the following medications: allopurinol, methotrexate, phenylbutazone or probenecid.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.