Active not recruitingPHASE4INTERVENTIONAL

Multifidus PET Scan Study

This research is investigating a treatment for people with ongoing low back pain. The treatment involves a small device that stimulates a specific back muscle called the multifidus. Doctors want to understand exactly how this stimulation works. They will use special scans (PET scans) to see if the treatment changes activity in the brain areas linked to pain, and also in the multifidus muscle itself. The study hopes to connect these physical changes to how much a person's pain improves, how well they can do daily activities, and their overall quality of life. This is a Phase 4 study, meaning the treatment is already available, and researchers are gathering more information about its effects.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Barts & The London NHS Trust

Enrolment target

Start

19 Aug 2021

Estimated completion

17 Mar 2027

Low Back Pain

What is this study about?

This study is about understanding a treatment for persistent low back pain. Many people suffer from back pain that doesn't go away, and finding effective ways to help them is very important. This particular treatment uses a small, implanted device that gently stimulates a muscle in the lower back called the multifidus. This muscle is key for supporting your spine.

We know this treatment can help some people with their pain, but we want to understand *how* it works at a deeper level. The main goal is to see if stimulating the multifidus muscle causes changes in the brain's pain centres and within the muscle itself. To do this, we'll use a special type of scan called a PET scan, which can show us how active different parts of your brain and muscles are. By looking at these changes, we hope to learn more about why some people feel less pain, can move better, and have a better quality of life after receiving this treatment.

This research is important because it could help doctors understand who might benefit most from this treatment and how it helps the body recover. It builds on previous successful studies, and by gathering more detailed information, we can continue to improve care for people living with chronic back pain.

Key takeaways

This study explores how a back muscle stimulator helps people with ongoing low back pain.
It uses special PET scans to look at changes in your brain and back muscles.
The goal is to understand how the treatment improves pain, movement, and quality of life.
You need to have specific levels of chronic back pain and have tried other treatments.
Participation involves surgery for the device and several follow-up appointments and scans.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To be part of this study, you generally need to be between 22 and 75 years old and have ongoing low back pain. Your pain needs to be at a moderate to severe level (rated between 6 and 9 out of 10), and it should have lasted for more than 90 days. You would also need to have some difficulty with daily activities due to your back pain.

It's important that you've tried other treatments for your back pain for at least 90 days, including physical therapy, and if you take pain medication, your dose should have been stable for the month before joining. You'd also need to be suitable for the surgery to implant the stimulation device, as decided by the surgeon.

Some things might prevent you from joining, such as having a very high Body Mass Index (BMI over 35), certain types of scoliosis (a curved spine), or a narrow spinal canal. If you have any neurological problems that might be linked to your back pain, you might also not be able to take part.

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 between 22 and 75 years old?
Do you have low back pain that has lasted for more than 3 months and is moderate to severe?
Have you tried physical therapy and other standard treatments for your back pain for at least 90 days?
Are you willing and able to have a small device implanted for stimulation?
Do you have a Body Mass Index (BMI) of 35 or less?
Do you *not* have significant scoliosis or spinal canal narrowing?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will have a device implanted to stimulate your multifidus muscle. This is a surgical procedure. Before and after the surgery, you will have several assessments. These will include filling out questionnaires about your pain, daily activities, and quality of life. The main part of the study involves having special PET scans, which look at your brain and muscle activity. You'll have these scans at different times to see how things change after the stimulation device is activated.

There will be follow-up appointments to check on your progress and make sure the device is working well. The exact number of visits and the total duration of your participation would be explained in full detail by the study team, but generally, studies like this involve several appointments over a period of months to track long-term effects. You would also be asked to continue taking any prescribed medications at a stable dose unless advised otherwise by the study doctor.

Potential risks and benefits

Taking part in any study involves considering potential benefits and risks. A possible benefit of this study is that the multifidus stimulator might help reduce your back pain and improve your ability to do daily activities, as it has done for many others. However, as with any surgery, there are risks involved with implanting the device, such as infection, bleeding, or problems with the device itself. The PET scans also involve a very small amount of radiation, similar to what you might receive from natural sources or other medical scans. You will be given full details of these risks before you agree to take part. Remember, joining this study is entirely your choice, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Barts Health NHS Trust
Verified postcode
London, United Kingdom

Common questions

What is the multifidus muscle?

It's a small but important muscle deep in your lower back that helps support and stabilise your spine.

What is a PET scan?

A PET scan is a special type of medical imaging that shows how active different parts of your body, like your brain or muscles, are. It uses a safe, temporary dye.

Is the stimulation device painful?

The stimulation is usually described as a gentle sensation, not painful. It's set to a comfortable level for you.

How long will I need to be in the study?

The total length of time you'd be involved will be fully explained by the study team, but typically involves several visits over many months.

Can I leave the study at any time?

Yes, you have the right to stop participating in the study at any point, and it won't affect your ongoing medical care.