AMOXICILLIN for Chronic low back pain | Non-specific low back pain

Inclusion criteria

• {"criterion_text":"- Aged 18-65 years.\n- Chronic low back pain (i.e. duration >6 months) after a previous (MRI confirmed) disc herniation within the past 6 months to 2 years.\n- 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?\n- 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.\n- Modic Type I changes visible on the MRI-scan in the vertebrae adjacent to the previous herniated disc."}

Exclusion criteria

• {"criterion_text":"- Received antibiotic treatment in the past month.\n- Hepatic or renal (eGFR≤30) impairment.\n- Current pregnancy, lactation or pregnancy-wish.\n- Severe physical or psychiatric co-morbidities.\n- LBP resulting from a specific cause such as a tumor or fracture.\n- Surgery or epidural injection in the past 6 months.\n- Previous antibiotic course of 100 days.\n- Contra-indication for amoxicillin use: allergy to penicillins/amoxicillin, cephalosporin or carbapenem; mononucleosis; leukemia; phenylketonuria (PKU).\n- Contra-indication for MRI.\n- Current use of any of the following medications: allopurinol, methotrexate, phenylbutazone or probenecid."}

Primary endpoints

• {"endpoint_text":"- Pain and disability measured with the Roland Morris Disability Questionnaire (RMDQ)","definition_or_measurement_approach":"Measured with the Roland Morris Disability Questionnaire (RMDQ)."}

Secondary endpoints

• {"endpoint_text":"- LBP-intensity (0-10 NRS-scale)","definition_or_measurement_approach":"Measured using 0-10 Numerical Rating Scale for low back pain intensity."}
• {"endpoint_text":"- Leg pain intensity (0-10 NRS-scale)","definition_or_measurement_approach":"Measured using 0-10 Numerical Rating Scale for leg pain intensity."}
• {"endpoint_text":"- Global perceived effect (7-point Likert scale)","definition_or_measurement_approach":"Measured using a 7-point Likert global perceived effect scale."}
• {"endpoint_text":"- Health-related quality of life (PROMIS-GH-10 and EQ-5D-5L)","definition_or_measurement_approach":"Measured using PROMIS-GH-10 and EQ-5D-5L instruments."}
• {"endpoint_text":"- Self-reported number of days with sick leave","definition_or_measurement_approach":"Self-reported days of sick leave via questionnaire."}
• {"endpoint_text":"- Co-interventions (pharmacological and non-pharmacological)","definition_or_measurement_approach":"Recorded co-interventions (pharmacological and non-pharmacological) as reported."}
• {"endpoint_text":"- Patients’ satisfaction with treatment (7-point Likert scale)","definition_or_measurement_approach":"Measured using a 7-point Likert scale for patient satisfaction."}
• {"endpoint_text":"- Success of blinding (patient and physician)","definition_or_measurement_approach":"Assessment of blinding success for patient and physician (method not further specified)."}
• {"endpoint_text":"- Compliance (pill count)","definition_or_measurement_approach":"Measured by pill count."}
• {"endpoint_text":"- Pain self-efficacy (Pain Self-Efficacy Questionnaire)","definition_or_measurement_approach":"Measured using the Pain Self-Efficacy Questionnaire."}
• {"endpoint_text":"- Sleep (Pittsburgh Sleep Quality Index)","definition_or_measurement_approach":"Measured using the Pittsburgh Sleep Quality Index."}
• {"endpoint_text":"- Neuropathic pain (PainDETECT)","definition_or_measurement_approach":"Measured using the PainDETECT questionnaire."}
• {"endpoint_text":"- MRI-imaging at 12 months follow-up (to investigate the outcome of the antibiotic treatment on the Modic changes)","definition_or_measurement_approach":"MRI imaging performed at 12 months follow-up to evaluate Modic changes."}
• {"endpoint_text":"- LBP-related health care costs measured with cost questionnaires (iMCQ and iPCQ)","definition_or_measurement_approach":"Health care costs measured with iMCQ and iPCQ cost questionnaires."}

Netherlands

Earliest CTIS Part Ii Submission Date

30-09-2024

Latest Decision Or Authorization Date

31-07-2025

Processing Time Days

304

Number Of Sites

3

Number Of Participants

204

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands