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Tests treatment safety and results for MSK Conditions
Official title Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial
ClinicalTrials.gov ID: NCT06771492
What this study is testing
What is Amoxicillin?
Amoxicillin is an investigational medicine, given as an once-daily, being studied as a potential treatment for msk conditions.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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?
You likely can't join if
- 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.
See the full eligibility 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...
- Modic Type I changes visible on the MRI-scan in the vertebrae adjacent to the previous herniated disc.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rotterdam, South Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rotterdam, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.