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Can a sleep hormone ease chronic back pain?

NCT ID NCT06859957

Symptom relief Sponsor: Bart Koes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing whether melatonin, a hormone the body makes to regulate sleep, can reduce pain in adults with chronic low back pain. The trial enrolls 222 people aged 18 to 65 who have had low back pain for at least three months and rate their pain at 4 or higher on a 0 to 10 scale. Participants take either 10 mg of melatonin or a placebo daily for six weeks. The main goal is to see if melatonin lowers average pain intensity compared with placebo, with additional checks on disability and how participants feel overall.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
melatonin
What this could lead to
If melatonin helps, it could offer a low-cost, widely available option for people with chronic low back pain, especially those who also struggle with sleep.
What could go wrong
Melatonin may not relieve pain better than a placebo, and the trial only follows participants for six weeks, so any benefit beyond that is unknown. Melatonin can cause drowsiness and is not risk-free for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

222 people

The number who actually took part.

Started

Apr 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * age 18-65 * understand and write Dutch * LBP for 3 months or longer * LBP must be present on 'most days' or 'every day' within the past 3 months * LBP must limit life or work activities on 'some days', 'most days', or 'every day' within the past 3 months * average LBP intensity of ≥4 on a 0-10 NRS in the past 7 days Exclusion Criteria: * LBP resulting from a specific cause such as malignancy, fracture, lumbar radiculopathy and spinal stenosis * Radiating pain into the leg that goes further (down) than the knee * Inflammatory/autoimmune arthritis * Severe physical or psychiatric co-morbidities * Contraindications to melatonin

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic low back pain (CLBP)

Contacts and locations

Locations

  • Erasmus MC

    Rotterdam, Netherlands

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