Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06771492

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

The goal of this clinical trial is to learn if antibiotics (amoxicillin) work to treat chronic low back pain in adults. In some patients, this type of back pain may be caused by bacteria in the vertebrae, resulting in a condition known as "Modic type I change."

The main questions the trial aims to answer are:

* What is the efficacy (primary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes? * What is the cost-effectiveness (secondary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes?

Researchers will compare amoxicillin to a placebo (a look-alike substance that contains no active drug) to see if amoxicillin works to treat chronic low back pain.

Participants in the trial will:

* Be invited for an MRI scan to determine if they have a Modic type I change; those who do will be included in the study. * Take either amoxicillin or a placebo daily for 100 days. * Take probiotics daily for 100 days to reduce the occurrence and impact of any side effects from the antibiotics. * Attend clinic visits at baseline (the start), 4 weeks, 3 months, and 12 months for checkups and tests. * Complete questionnaires at baseline, 3 months, 6 months, and 12 months.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

MSK Conditions Back Pain Chronic Low Back Pain (CLBP) Low Back Pain Modic Changes Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location status: Recruiting

Location contact

Bart Koes, Prof. Dr.

CONTACT

[email protected]

+31107043620

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amoxicillin

Drug

Antibiotic treatment (amoxicillin) with a dosage of 1000 mg (3 times a day) for a period of 100 days

Placebo

Other

Placebo with a dose of 1000 mg (3 times a day) for a period of 100 days

Primary outcomes

  1. Roland Morris Disability Questionnaire (RMDQ)

    Time frame: The measurements are scheduled at baseline and at 3, 6 and 12 months follow-up.

    The primary outcome is pain and disability measured with the Roland Morris Disability Questionnaire (RMDQ). The scale ranges from 0-24 in which a higher score indicates higher disability. The RMDQ was also the primary outcome in the previous trials, and it is a recommended core outcome measure for trials in LBP.

Secondary outcomes

  1. LBP-intensity (0-10 NRS-scale)

    Time frame: Measured at baseline, 3 months, 6 months and 12 months

    In the form of a questionnaire

  2. Leg pain intensity (0-10 NRS-scale)

    Time frame: Measured at baseline, 3 months, 6 months and 12 months

    In the form of a questionnaire

  3. Health-related quality of life (PROMIS-GH-10)

    Time frame: Measured at baseline, 3 months, 6 months and 12 months

    In the form of a questionnaire

  4. Health-related quality of life (EQ-5D-5L)

    Time frame: Measured at baseline, 3 months, 6 months and 12 months

    In the form of a questionnaire

  5. Self-reported number of days with sick leave

    Time frame: Measured at baseline, 3 months, 6 months and 12 months

    In the form of a questionnaire

  6. Co-interventions (pharmacological and non-pharmacological)

    Time frame: Measured at baseline, 3 months and 12 months

    In the form of a questionnaire

  7. Global perceived effect (7-point Likert scale)

    Time frame: Measured at 3 months, 6 months and 12 months

    In the form of a questionnaire

  8. Patients' satisfaction with treatment (7-point Likert scale)

    Time frame: Measured at baseline, 3 months and 12 months

    In the form of a questionnaire

  9. Success of blinding

    Time frame: Measured at 3 months and 12 months

    In the form of a questionnaire

  10. Compliance

    Time frame: Measured at 3 months

    A pill count will be conducted

  11. Pain self-efficacy (Pain Self-Efficacy Questionnaire)

    Time frame: Measured at baseline, 3 months, 6 months and 12 months

    In the form of a questionnaire

  12. Sleep questionnaire (Pittsburgh Sleep Quality Index)

    Time frame: Measured at baseline, 3 months, 6 months and 12 months

    In the form of a questionnaire

  13. Neuropathic pain (PainDETECT)

    Time frame: Measured at baseline, 3 months, 6 months and 12 months

    In the form of a questionnaire

  14. Cost questionnaires (Medical Consumption Questionnaire)

    Time frame: Measured at 3 months, 6 months and 12 months

    In the form of a questionnaire

  15. Cost questionnaires (Productivity Cost Questionnaire)

    Time frame: Measured at 3 months, 6 months and 12 months

    In the form of a questionnaire

  16. Gut microbiome composition

    Time frame: Measured at baseline, 3 months, and 12 months

    The possible collateral impact of antibiotics on the microbiome would be investigated by comparing the abundance and diversity of microbial and resistome composition between patients in amoxicillin and placebo groups. They would be characterized using whole shotgun and functional metagenomic sequencing data (Dhariwal et al. Gut Microbes, 2023).

    In short, stools of the patients will be collected at baseline, 3 months, and 12 months. From these samples, the microbial DNA will be extracted using a commercial kit. Libraries for shotgun metagenomic sequencing would be prepared using Ilumina sequencing platform. Low quality and adapter sequences from paired-end reads will be filtered, and human DNA contaminant sequences will be discarded. The high-quality reads will be subjected to taxonomic classification. CARD antimicrobial resistance database will be used to annotate metagenomic reads.

Study contacts

Contact information is provided by the study sponsor or research team.

Tamana Meihandoest, MSc

CONTACT

[email protected]

+31627571742

Sponsors and collaborators

Lead sponsor

Bart Koes

Other

Collaborators

  • Erasmus University Rotterdam

Registry information

Acronym: ABBA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.