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

NCT06771492 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-08-06

No results posted yet for this study

Summary

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.

Conditions

  • MSK Conditions
  • Chronic Low Back Pain (CLBP)
  • Modic Changes

Interventions

DRUG

Amoxicillin

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Erasmus University Rotterdam

    collaborator OTHER

  • Bart Koes

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-02
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06771492 on ClinicalTrials.gov