Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, Netherlands
Actively Recruiting
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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