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RECRUITING
NCT06859957
PHASE3

Melatonin for Patients With Chronic Low Back Pain

Sponsor: Bart Koes

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2025-04-11

Completion Date

2026-12

Last Updated

2025-08-22

Healthy Volunteers

No

Interventions

DRUG

Melatonin 10 mg

10 mg melatonin daily for a period of 6 weeks

DRUG

Placebo

Daily placebo for a period of 6 weeks

Locations (1)

Erasmus MC

Rotterdam, Netherlands