Actively Recruiting
Melatonin for Patients With Chronic Low Back Pain - a Randomized Placebo-controlled Trial
Led by Bart Koes · Updated on 2025-08-22
240
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic low back pain (LBP) is a common cause of disability worldwide, with many patients experiencing ongoing pain and sleep difficulties. This trial is designed to evaluate the effect of melatonin compared to a placebo in adults with chronic LBP, aiming to better understand its potential for pain relief. The study is a randomized, triple-blind, placebo-controlled Phase 3 trial. Participants will receive either 10 mg of melatonin or a placebo daily for six weeks. The study compares these two groups to assess changes in pain intensity and other health outcomes. The treatment period is six weeks, after which participants will be followed up for up to six months to monitor longer-term effects. Throughout the study, participants will undergo assessments including pain intensity, disability related to back pain, global health, sleep quality, emotional functioning, and health-related quality of life. Researchers will also track sick leave days, healthcare usage, productivity losses, and any adverse events. These measurements will occur at baseline, after treatment, and during follow-ups at three and six months. The total involvement spans from the start of treatment through six months of follow-up.
CONDITIONS
Brief 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
- Ability 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 like malignancy, fracture, lumbar radiculopathy, or spinal stenosis
- Radiating pain into the leg that extends beyond the knee
- Inflammatory or autoimmune arthritis
- Severe physical or psychiatric conditions
- Contraindications to melatonin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants take 10 mg of melatonin or a placebo daily for 6 weeks to assess effects on chronic low back pain.
1 baseline visit and periodic visits during treatment
Duration - 6 months
Participants are followed for up to 6 months after treatment to assess long-term effects on pain, disability, quality of life, and other health measures.
Visits at 3 months and 6 months post-treatment
Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, Netherlands
Actively Recruiting
Research Team
P
Prof. dr. B.W. (Bart) Koes
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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