AuthorisedTherapeutic use (Phase IV)Interventional

Erector Spinae Plane Block for acute low back pain: a prospective double-blind randomized multicenter study. ESP-BACK

This study is investigating a new treatment for sudden, severe lower back pain, often called acute low back pain. It's called an Erector Spinae Plane Block, which is an injection. The main aim is to find out if this injection can significantly reduce your pain when you move, within just 30 minutes of having it. Researchers will also check if it helps you stand up and walk more easily during that time. They are comparing this new injection against standard care to see which is more effective. This is an important step to see if this treatment could offer quick relief for people struggling with acute lower back pain.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Universitaire De Montpellier

Enrolment target

300

Start

26 Nov 2025

Acute low back pain

What is this study about?

Imagine you've suddenly got a really bad pain in your lower back. This kind of pain can make it hard to move and do everyday things. Doctors and researchers are always looking for better ways to help people feel better quickly when this happens. This study, called ESP-BACK, is looking into a new approach involving a special injection.

The injection is called an 'Erector Spinae Plane Block.' It's given in the back, near the spine, to help numb the nerves that are causing the pain. The main goal of this study is to see if this injection can cut your pain by half when you try to move, and help you get up and walk around more easily within 30 minutes of having it. They're comparing this injection to the usual treatments you might receive, to understand which helps people more effectively and quickly.

This kind of study is like the final step before a treatment might become widely available. They're collecting lots of information, not just about pain, but also how it affects your sleep, your general health, how much pain medication you need, and even how long it takes for you to get back to work. This helps them understand the full picture of how the treatment might help people in real-life situations.

Key takeaways

This study is for people with sudden, severe lower back pain.
It's testing a new injection (Erector Spinae Plane Block) against standard treatments.
The main goal is to see if the injection reduces pain and helps movement quickly.
Participants will be followed for up to 6 months to track pain, mobility, and well-being.
It's a 'Phase IV' study, meaning the treatment approach is already in use for some conditions, and this study looks at its use for acute low back pain.

Who may be eligible?

This study is open to both men and women who are at least 18 years old. There's no upper age limit for joining.

To be considered, you need to have sudden (acute) lower back pain. The doctors involved will carefully check your medical history and current health to make sure this study is right for you and that taking part would be safe.

It's important that you discuss your interest with your doctor, as they will confirm if your specific situation matches what the researchers are looking for in participants.

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 at least 18 years old?
Do you have sudden (acute) lower back pain?
Are you able to attend follow-up appointments for up to 6 months?
Are you willing to complete questionnaires about your pain and daily activities?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the new Erector Spinae Plane Block injection or standard treatment. Right after the procedure, researchers will check how much your pain has reduced when you move, and how easily you can stand and walk.

Over the next six months, you would complete questionnaires about your pain levels, sleep quality, and general well-being. You might also be asked about how many pain medications you've used, how many steps you've taken (possibly using a device), how many times you've seen a doctor or physiotherapist for your back pain, and when you returned to work. Some follow-up will involve questionnaires at specific times, such as 14 days, 3 months, and 6 months after the initial procedure. The total duration of your involvement in the study would be up to 6 months.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from receiving a treatment that could help your acute lower back pain. However, there's no guarantee the treatment will work for everyone, and it might not work for you. As with any medical procedure or medication, there could be side effects, like discomfort from the injection or side effects from any pain relief you take. You will be closely monitored for any adverse effects. You are free 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
France

Common questions

What is 'acute low back pain'?

It means you have sudden and severe pain in your lower back, which is relatively new and hasn't been there for a long time.

What is an Erector Spinae Plane Block?

It's a specific type of injection given in your back, designed to help numb the nerves causing your lower back pain.

How long will I be in the study?

Your involvement in the study will last for up to 6 months after the initial procedure.

Will I definitely get the new injection?

Because this is a comparison study, you might receive the new injection or the usual standard care for your back pain. You won't know which one you get.

Can I stop participating if I want to?

Yes, you can leave the study at any time, for any reason, without it affecting your regular medical care.