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New treatment option for Chronic Low-back Pain (cLBP)
Official title Melatonin for Patients With Chronic Low Back Pain
ClinicalTrials.gov ID: NCT06859957
What this study is testing
What is Melatonin 10 mg?
Melatonin 10 mg is an investigational medicine, given as an once-daily, being studied as a potential treatment for chronic low-back pain (clbp).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Low back pain is one of the conditions causing more disability worldwide. The use of pain medications is substantial in patients with chronic LBP.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
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
See the full eligibility 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
- 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.
Where it's taking place
- Rotterdam, Netherlands
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 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rotterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.