RecruitingOBSERVATIONAL

Radiofrequency Denervation and Brain Imaging

This research wants to understand how a treatment for long-lasting lower back pain, called radiofrequency denervation, affects the brain. Many people suffer from lower back pain, and this treatment can help some. The study will use special brain scans, called MRIs, to see if there are any changes in the brain's activity or structure after patients have this treatment. Researchers are hoping to find out how much the brain changes and what these changes mean. By doing this, they aim to figure out who is most likely to benefit from radiofrequency denervation in the future and improve how we understand and treat lower back pain.

At a glance

Status

Recruiting

Sponsor

University of Aberdeen

Enrolment target

Start

03 Apr 2023

Estimated completion

30 Sep 2026

Low Back Pain, Mechanical

What is this study about?

Imagine you've had lower back pain for a long time, and your doctors think a treatment called radiofrequency denervation might help. This treatment uses heat to calm down certain nerves that are causing your pain. This study wants to peek inside your brain to see how it responds to this treatment. It's like taking a picture of your brain before the treatment, after a special injection to see if the treatment will work, and then a few months after the full treatment.

Lower back pain is really common and can make everyday life difficult. We know that long-term pain can affect how the brain works. This study thinks that by looking at brain scans, we might be able to understand why some people get a lot of relief from radiofrequency denervation and others don't. The researchers want to see if the brain patterns change in a specific way after this treatment.

The information gathered from these brain scans will be really helpful. It could lead to better ways of choosing who gets this treatment, make the treatment even better in the future, and help us develop new, more effective ways to measure pain and treatment success in other studies. It's all about making sure patients get the right treatment for their pain.

Key takeaways

This study uses brain scans to understand how radiofrequency denervation helps lower back pain.
It aims to identify specific brain changes after this treatment.
Participation involves three MRI scans and filling out questionnaires over several months.
The findings could help doctors better select patients for this treatment in the future.
You won't receive new treatments specifically for the study, just the standard care and observations.
Your involvement could help improve future understanding and treatment of long-term back pain.

Who may be eligible?

To be considered for this study, you need to be 18 years old or older and have long-term lower back pain that's at least moderate in severity. Your doctor must also think that radiofrequency denervation is a suitable treatment option for your pain. The study is looking for back pain that's clearly coming from a specific area, rather than widespread body pain, and you should be able to speak English and understand what you're agreeing to.

Before the main treatment, you'll have a test injection. If this injection significantly reduces your pain (by 80% or more for a few hours), it suggests you might be a good candidate for the denervation treatment and this study. It's also important that any pain medicines you're currently taking are working well and you're not planning to change them.

However, some things would mean you can't join. For example, if you have something in your body, like a pacemaker, that means you can't have an MRI scan. Also, if you're pregnant, have very serious anxiety or depression, or have certain other long-term pain conditions like fibromyalgia, you wouldn't be able to take part. They also can't include you if you've already had radiofrequency denervation or are taking several strong pain medications.

Quick self-check

Are you 18 or older?
Do you have chronic, moderate to severe lower back pain that your doctor thinks could benefit from radiofrequency denervation?
Have you had a test injection that reduced your pain significantly (by 80% or more for about 3 hours)?
Are you able to lie still for an MRI scan and do not have any metal implants like a pacemaker?
Do you feel generally well, without severe anxiety or depression, or other types of widespread chronic pain conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will have three special brain scans called MRI scans. The first scan will be done before any treatment. The second scan will be after you've had a test injection to see if the radiofrequency treatment is likely to work for you. The final scan will be about three months after you've had the radiofrequency denervation treatment itself.

Besides the MRI scans, you'll also be asked to complete some questionnaires. These questions will ask about your pain levels, how your pain affects your daily activities, and your general health and wellbeing. There won't be any new medications given as part of this study; it's looking at the effects of a treatment you're already receiving. The exact total duration will depend on the timing of your treatments, but it generally involves scans and questionnaires spread over a few months.

Potential risks and benefits

Taking part in this study won't directly improve your pain more than the treatment itself would. However, by joining, you'll be contributing to important research that could help us understand lower back pain better and improve future treatments for many people. The main risk involves the MRI scans; they are generally safe, but you'll need to lie still in a scanner which some people find uncomfortable. There are also very rare risks associated with the radiofrequency denervation treatment, which your doctor will explain fully. You are completely free to withdraw from the study at any time without giving a reason, and this won't affect your medical care.

Locations (1)

Aberdeen Royal Infirmary
Aberdeen, United Kingdom· Recruiting

Common questions

What is radiofrequency denervation?

It's a treatment for long-term back pain that uses heat to calm down specific nerves causing the pain.

What is an MRI scan?

An MRI is a special type of scan that uses magnets and radio waves to create detailed pictures of the inside of your body, including your brain.

Will I get extra treatment by joining this study?

No, this study observes the effects of the treatment you would already be having. You won't receive extra medication or procedures specifically for the study.

How long does the study last?

You'll have scans and questionnaires over several months, depending on the timing of your treatments.

Do I have to take part?

No, taking part is completely voluntary. Your decision won't affect your medical care in any way.

How to find out more

Saravanakumar NA Kanakarajan, Dr

Saravanakumar.kanakarajan@nhs.scot 01224 553237 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.