Actively Recruiting
Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial
Led by Bart Koes · Updated on 2025-08-06
204
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
B
Bart Koes
Lead Sponsor
E
Erasmus University Rotterdam
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-65 years.
- Chronic low back pain lasting more than 6 months after a confirmed disc herniation within the past 6 months to 2 years.
- At least two of the following: training or exercise increases pain, sleep disturbed due to back pain, pain when turning over in bed at night, or morning pain.
- Mean pain intensity of at least 5 on a 0-10 scale, based on current pain, worst pain in past two weeks, and usual mean pain in past two weeks.
- Modic Type I changes visible on MRI near the previous herniated disc.
You will not qualify if you...
- Received antibiotic treatment in the past month.
- Current pregnancy, lactation, or desire to become pregnant.
- Severe physical or psychiatric conditions.
- Low back pain caused by specific issues like tumor or fracture.
- Surgery or epidural injection in the past 6 months.
- Previous antibiotic course lasting 100 days.
- Allergies or contraindications to amoxicillin or related drugs.
- Contraindication for MRI.
- Current use of allopurinol, methotrexate, phenylbutazone, or probenecid.
- Liver or kidney impairment (eGFR ≤30).
- Difficulty swallowing capsules.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
Research Team
T
Tamana Meihandoest, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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