Melatonin for chronic low back pain
Official title: Melatonin for Patients With Chronic Low Back Pain - a Randomized Placebo-controlled Trial
Run by Erasmus Medical Center · NCT06859957 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This trial will test whether taking 10 mg of melatonin helps adults aged 18–65 with chronic low back pain lower their pain compared with a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT06859957 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 who read and write Dutch, have non-specific low back pain most days for at least three months, and report average pain of 4/10 or higher are the intended participants.
✕Probably not a fit
Patients whose back pain has a specific cause (such as cancer, fracture, lumbar radiculopathy past the knee, or inflammatory arthritis), those with severe medical or psychiatric conditions, or anyone with contraindications to melatonin are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 interventional trial compares 10 mg melatonin with a matching placebo in adults who have had chronic low back pain for at least three months. Eligible participants are Dutch-speaking adults aged 18–65 who report pain most days and an average pain intensity of 4 or higher on a 0–10 numeric scale. People with specific causes of back pain (for example malignancy, fracture, radiculopathy that extends below the knee, or inflammatory arthritis), severe comorbidities, or contraindications to melatonin are excluded. The main aim is to determine whether melatonin reduces pain (and may improve sleep) compared with placebo.
Why it matters
Potential benefit: If effective, melatonin could offer a low-cost, well-tolerated option to reduce pain and improve sleep for people with chronic low back pain.
How similar studies have gone: Preliminary small studies have suggested melatonin may help with pain and sleep, but large randomized Phase 3 evidence is still limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Erasmus MC
Rotterdam, Netherlands Recruiting
Study contacts
- Study coordinator: Prof. dr. B.W. (Bart) Koes
- Email: b.koes@erasmusmc.nl
- Phone: 010-7035882
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.