Testing antibiotics for chronic low back pain linked to Modic changes

Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial

This study is testing if the antibiotic amoxicillin can help adults with chronic low back pain caused by Modic changes feel better compared to a placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 204 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Erasmus Medical Center (other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Rotterdam, South Holland)
• Trial ID: NCT06771492 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with chronic low back pain lasting more than six months and confirmed Modic type I changes on MRI.

Not a fit: Patients who have received antibiotics in the past month or have severe co-morbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from chronic low back pain linked to bacterial infection.

How similar studies have performed: While the use of antibiotics for chronic low back pain is a novel approach, previous studies have shown mixed results, indicating the need for further investigation.

Eligibility criteria

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 this trial is running

Rotterdam, South Holland

• Erasmus Medical Center — Rotterdam, South Holland, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Tamana Meihandoest, MSc

Conditions: MSK Conditions, Chronic Low Back Pain, Modic Changes, Antibiotics, Amoxicillin, Low back pain, Modic changes, Randomized controlled trial