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Study on Melatonin for Patients with Chronic Low Back Pain: A Randomized Trial

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of chronic low back pain, a condition where pain persists in the lower back for an extended period, often affecting daily activities. The treatment being tested is Melatonin, a substance commonly known for its role in regulating sleep. In this study, participants will take a 10 mg dose of melatonin in tablet form once daily before bedtime for a period of six weeks.

The purpose of the study is to determine if melatonin is more effective than a placebo in reducing pain intensity in individuals with chronic low back pain. Participants will be randomly assigned to receive either melatonin or a placebo, and neither the participants nor the researchers will know who is receiving which treatment until the study is completed. This approach is known as a double-blind study, which helps ensure the results are unbiased.

Throughout the study, participants will be asked to report their pain levels, which will be measured on a scale from 0 to 10. The main goal is to see if there is a significant difference in pain reduction between those taking melatonin and those taking the placebo after six weeks of treatment. This trial aims to provide valuable insights into whether melatonin can be a beneficial treatment option for managing chronic low back pain.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age between 18 to 65 years, presence of chronic low back pain (LBP) for at least 3 months, and an average pain intensity of 4 or more on a 0-10 scale in the past week.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving melatonin and the other receiving a placebo. This process is double-blind, meaning neither the participants nor the researchers know which group each participant is in.

  3. Step 3

    Medication administration

    Participants in the melatonin group receive Melatonine Tiofarma 5 mg tablets. The dosage is 10 mg, taken orally once daily before bedtime. This regimen is followed for a duration of 6 weeks.

  4. Step 4

    Monitoring and reporting

    Throughout the 6-week period, participants are required to monitor and report their pain intensity. This is measured using a numerical rating scale (NRS) from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable.

  5. Step 5

    Final assessment

    At the end of the 6-week treatment period, a final assessment is conducted to evaluate changes in pain intensity. The primary focus is on the difference in pain levels from the start of the trial to the end.

Who can join the trial?

5 criteria

  • Must be between the ages of 18 and 65.
  • Must have had chronic low back pain for 3 months or longer. This means the pain has been present for at least 3 months.
  • The low back pain must have been present on most days within the past 3 months.
  • The low back pain must have limited your daily life or work activities within the past 3 months.
  • The average intensity of the low back pain must be at least 4 on a scale from 0 to 10 in the past 7 days. This scale is called the Numerical Rating Scale (NRS), where 0 means no pain and 10 means the worst possible pain.

Who cannot join the trial?

8 criteria

  • Patients who are not experiencing chronic low back pain cannot participate. Chronic low back pain is long-lasting pain in the lower back area.
  • Patients who are under 18 years old cannot participate.
  • Patients who are unable to take melatonin or have allergies to it cannot participate. Melatonin is a hormone that helps regulate sleep.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a history of substance abuse or addiction cannot participate.
  • Patients who have a mental health condition that the study doctors believe would interfere with their ability to participate cannot participate.
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Investigated drugs

Melatonin is a medication being tested in this trial for its potential to help reduce pain intensity in patients with chronic low back pain. It is taken once daily before bedtime for a period of 6 weeks. The trial aims to determine if melatonin is more effective than a placebo in improving pain levels in these patients.

What is already known about the treatment

Melatonin – Melatonin is administered orally in the form of tablets, typically taken once daily before bedtime. It is currently being studied in clinical trials for its potential benefits in managing chronic low back pain. The main therapeutic indication being explored is its ability to reduce pain intensity in patients suffering from this condition. At the molecular level, melatonin works by regulating the sleep-wake cycle and has antioxidant properties that may help reduce inflammation and pain. It is classified pharmacologically as a hormone and is commonly used as a sleep aid.

Investigated diseases

Chronic Low Back Pain – This condition is characterized by persistent pain in the lower back region that lasts for more than three months. It can result from various causes, including muscle strain, spinal disc issues, or arthritis. The pain may be constant or intermittent and can vary in intensity. It often affects daily activities and can lead to reduced mobility and flexibility. Over time, individuals may experience muscle weakness or stiffness in the back. The condition can also impact sleep and overall quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514769-20-00Estimated enrolment220 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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