Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
240 participants
INTERVENTIONAL
2025-04-11
2026-12-31
Brief Summary
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The objective of this study is to investigate the efficacy of melatonin, relative to placebo, in patients with chronic LBP.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo
Daily placebo for a period of 6 weeks
Melatonin
10mg of melatonin daily for a period of 6 weeks
Melatonin 10 mg
10 mg melatonin daily for a period of 6 weeks
Interventions
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Melatonin 10 mg
10 mg melatonin daily for a period of 6 weeks
Placebo
Daily placebo for a period of 6 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* Radiating pain into the leg that goes further (down) than the knee
* Inflammatory/autoimmune arthritis
* Severe physical or psychiatric co-morbidities
* Contraindications to melatonin
18 Years
65 Years
ALL
No
Sponsors
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Bart Koes
OTHER
Responsible Party
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Bart Koes
Prof. dr.
Locations
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Erasmus MC
Rotterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-514769-20-00
Identifier Type: CTIS
Identifier Source: secondary_id
PaNaMa 11825
Identifier Type: -
Identifier Source: org_study_id
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