NCT06771492 Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial
| NCT ID | NCT06771492 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Bart Koes |
| Condition | MSK Conditions |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2025-04-02 |
| Primary Completion | 2027-08 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
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 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