Melatonin for Patients With Chronic Low Back Pain

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Chronic Low-back Pain (cLBP)

In brief

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.

Key facts

Study ID

NCT06859957

Run by

Bart Koes

People needed

240

Starts

2025-04-11

Expected to finish

2026-12-01

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify 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
• average LBP intensity of ≥4 on a 0-10 NRS in the past 7 days

You may not qualify 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

Where it is running

• Erasmus MC — Rotterdam, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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