Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT06859957
Eligibility Criteria:
Inclusion Criteria:
* age 18-65
* understand and write Dutch
* LBP for 3 months or longer
* LBP must be present on 'most days' or 'every day' within the past 3 months
* LBP must limit life or work activities on 'some days', 'most days', or 'every day' within the past 3 months
* average LBP intensity of ≥4 on a 0-10 NRS in the past 7 days
Exclusion Criteria:
* LBP resulting from a specific cause such as malignancy, fracture, lumbar radiculopathy and spinal stenosis
* Radiating pain into the leg that goes further (down) than the knee
* Inflammatory/autoimmune arthritis
* Severe physical or psychiatric co-morbidities
* Contraindications to melatonin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06859957
Study Brief:
Protocol Section:
NCT06859957