Testing antibiotics for chronic low back pain linked to Modic changes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of amoxicillin in treating chronic low back pain associated with Modic type I changes in adults. Participants will undergo MRI scans to confirm the presence of Modic changes and will be randomly assigned to receive either amoxicillin or a placebo for 100 days. The study will also assess the cost-effectiveness of the antibiotic treatment. By comparing outcomes between the two groups, researchers hope to determine if antibiotics can provide relief for this specific type of back pain.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* Received antibiotic treatment in the past month.
* 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.
* Hepatic or renal (eGFR≤30) impairment.
* Inability to swallow capsules.

Where it's running

• Erasmus Medical Center
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Tamana Meihandoest, MSc
• Email: t.meihandoest@erasmusmc.nl
• Phone: +31627571742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.