NCT06859957

Melatonin for Patients With Chronic Low Back Pain

Melatonin for Patients With Chronic Low Back Pain - a Randomized Placebo-controlled Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Bart Koes · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Low-back Pain (cLBP)

Interventions

Type	Name	Description
DRUG	Melatonin 10 mg	10 mg melatonin daily for a period of 6 weeks
DRUG	Placebo	Daily placebo for a period of 6 weeks

Timeline

• Start date: 2025-04-11
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-03-05
• Last updated: 2025-08-22

Locations

1 site across 1 country: Netherlands