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Melatonin for patients with chronic low back pain - a randomized placebo-controlled trial
EU CTIS ID: 2024-514769-20-00
What this study is testing
The aim of this randomized double-blind placebo-controlled clinical superiority trial is to investigate if daily treatment with melatonin 10mg once daily before bedtime for 6 weeks is superior compared with placebo in improving pain intensity assessed at 6 weeks after treatment initiation in patients with chronic LBP.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18 to 65
- LBP for 3 months or longer
- LBP must be present on most days within the past 3 months
- LBP must limit life or work activities within the past 3 months
- Average LBP intensity of ≥4 on a 0-10 NRS in the past 7 days
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.