Melatonin for Patients With Chronic Low Back Pain
Active, not recruitingPhase 3NCT06859957
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Low back pain is one of the conditions causing more disability worldwide. The use of pain medications is substantial in patients with chronic LBP. But the efficacy of commonly used analgesics is modest. More than half of patients with chronic LBP also has sleep problems. In recent years, some preliminary studies have shown a promising effect of melatonin for the treatment of pain. The objective of this study is to investigate the efficacy of melatonin, relative to placebo, in patients with chronic LBP.
Study details
- Official title
- Melatonin for Patients With Chronic Low Back Pain - a Randomized Placebo-controlled Trial
- Conditions
- Interventions
- Drug: Melatonin 10 mg
- Drug: Placebo
- Sponsor
- Bart Koes
- Organization
- Erasmus Medical Center
- Start date
- 2025-04-11
- Primary completion
- 2026-12
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Netherlands
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06859957