Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Melatonin for Chronic back pain (The MOCHA trial)

The MOCHA trial is a research study investigating if melatonin, a naturally occurring hormone, could be a helpful treatment for people suffering from chronic (long-lasting) back pain. Participants will be given either a melatonin tablet or a 'dummy' tablet (placebo) that looks identical, so neither they nor their doctors will know which they are taking. Over six weeks, researchers will measure changes in back pain intensity, using a simple 0-10 pain scale, to compare how well melatonin works against the dummy pill. The study also looks at how back pain affects daily life, overall health, and sleep, to get a full picture of any potential benefits.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Odense University Hospital

Enrolment target

220

Start

14 Mar 2024

Chronic back pain

What is this study about?

Imagine living with back pain every day – that's what we call chronic back pain. It can make even simple tasks tough. Researchers are always looking for new ways to help people manage this kind of pain. One interesting area they're exploring is melatonin. You might know melatonin as something that helps with sleep, but it might have other effects too.

This study, called 'The MOCHA trial', is designed to see if melatonin can really make a difference for people with ongoing back pain. They want to compare it directly with a 'dummy' pill, called a placebo. The idea is to find out if taking melatonin actually reduces pain more than just believing you're taking something that might help. This is a common and very important way to test new treatments.

To do this, the study will involve giving some people melatonin tablets and others identical-looking dummy tablets. Neither the participants nor their doctors will know who is getting what, which helps make the results fair and unbiased. Over six weeks, people in the study will be asked to regularly rate their pain, and researchers will carefully look at these scores to see if there's a real and noticeable improvement with melatonin compared to the dummy pill. They'll also check how participants' daily lives, general health, and sleep are affected.

Key takeaways

This study investigates if melatonin can reduce chronic back pain.
It compares melatonin to a 'dummy' pill (placebo) to see if it makes a real difference.
Participants will report their pain levels and how it affects their daily life over six weeks.
Both men and women aged 18 and over with chronic back pain can potentially join.
The study aims to understand if melatonin could be a safe and effective new option for back pain.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning people of all adult ages can join in.

This study is open to both men and women. The main requirement is that you are experiencing chronic back pain, which means back pain that has been ongoing for a while.

Important note: Because this study is testing melatonin, you won't be able to join if you are already taking certain medications or have specific health conditions that might interfere with the study or make melatonin unsafe for you. The study team will check all of this carefully to make sure it's safe for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have ongoing (chronic) back pain?
Are you able to take tablets as prescribed?
Are you willing to answer questions about your pain and health regularly?
Are you not currently taking medications that might interfere with melatonin or the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a check-up to make sure you are suitable. If you are, you'll be given either the melatonin tablets or a dummy tablet to take for six weeks. You won't know which one you're taking. Throughout these six weeks, you'll be asked to regularly report your pain levels, usually by using a simple numbering scale (like from 0 to 10) to describe your pain over the last week. You'll also complete some short questionnaires about how your back pain affects your daily activities, your overall well-being, and your sleep. There will likely be a few visits to the study clinic – one at the start, and then follow-up visits or contact at different points during the six weeks to check on your progress and collect information. The total amount of time you'd be involved in the actual treatment and assessment part of the study would be six weeks.

Potential risks and benefits

Participating in any study has potential benefits and potential risks. You might benefit if the melatonin helps your back pain, your daily activities, or your sleep. However, there's also a chance you could be taking the dummy pill and your pain might not improve. Potential risks could include side effects from the melatonin, although it is generally considered safe. The study team will explain all known risks to you before you agree to take part. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is chronic back pain?

Chronic back pain is back pain that has lasted for a long time, usually three months or more. It can affect daily life and make it hard to do normal activities.

What is a placebo?

A placebo is a 'dummy' tablet or treatment that looks exactly like the real medication but contains no active ingredients. It helps researchers see if any improvements are truly due to the medicine being tested or other factors.

Will I know if I'm taking melatonin or the dummy pill?

No, neither you nor your doctor will know whether you are taking melatonin or the dummy pill. This is called a 'blinded' study and helps ensure the results are fair.

How long will I be in the study?

The main part of the study, where you take the tablets and report your pain, will last for six weeks.

What kind of questions will I be asked?

You'll be asked to rate your pain on a simple scale, and answer questions about how your back pain affects your daily life, your general health, and your sleep.