Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial
Recruiting
Phase 3
Interventional Study
MSK Conditions
Chronic Low Back Pain (CLBP)
Modic Changes
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 204 (estimated)
- Sponsor
- Bart Koes · Other
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About This 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 ch…
Trial Locations
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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 pa…
Contacts