Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBart Koes
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 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
This trial does not accept healthy volunteersQualifiers
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.
Does training and/or exercise increase your pain?
Is your sleep during the night disturbed due to your back pain?
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Amoxicillin
DrugAntibiotic treatment (amoxicillin) with a dosage of 1000 mg (3 times a day) for a period of 100 days
Placebo
Other interventionPlacebo with a dose of 1000 mg (3 times a day) for a period of 100 days
Treatment groups
204 Participants
are divided into 2 treatment groupsGroup A: Antibiotic treatment (amoxicillin)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Roland Morris Disability Questionnaire (RMDQ)
The primary outcome is pain and disability measured with the Roland Morris Disability Questionnaire (RMDQ). The scale ranges from 0-24 in which a higher score indicates higher disability. The RMDQ was also the primary outcome in the previous trials, and it is a recommended core outcome measure for trials in LBP.
Time frame
The measurements are scheduled at baseline and at 3, 6 and 12 months follow-up.Secondary outcomes
1
LBP-intensity (0-10 NRS-scale)
In the form of a questionnaire
Time frame
Measured at baseline, 3 months, 6 months and 12 months2
Leg pain intensity (0-10 NRS-scale)
In the form of a questionnaire
Time frame
Measured at baseline, 3 months, 6 months and 12 months3
Health-related quality of life (PROMIS-GH-10)
In the form of a questionnaire
Time frame
Measured at baseline, 3 months, 6 months and 12 months4
Health-related quality of life (EQ-5D-5L)
In the form of a questionnaire
Time frame
Measured at baseline, 3 months, 6 months and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bart Koes
Lead sponsor
Erasmus Medical Center
Sponsor institution
Erasmus University Rotterdam
Collaborator
Source ClinicalTrials.gov