Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT06859957

Melatonin for Patients With Chronic Low Back Pain

Led by Bart Koes · Updated on 2025-08-22

240

Participants Needed

1

Research Sites

85 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Melatonin for Patients With Chronic Low Back Pain

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Able to understand and write Dutch
  • Low back pain lasting 3 months or longer
  • Low back pain present on most days or every day in the past 3 months
  • Low back pain limits life or work activities on some days, most days, or every day in the past 3 months
  • Average low back pain intensity of 4 or higher on a 0-10 scale in the past 7 days
Not Eligible

You will not qualify if you...

  • Low back pain caused by specific conditions such as malignancy, fracture, lumbar radiculopathy, or spinal stenosis
  • Radiating pain in the leg extending below the knee
  • Inflammatory or autoimmune arthritis
  • Severe physical or psychiatric co-morbidities
  • Contraindications to melatonin

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Erasmus MC

Rotterdam, Netherlands

Actively Recruiting

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Research Team

P

Prof. dr. B.W. (Bart) Koes

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Melatonin for Patients With Chronic Low Back Pain | DecenTrialz