RecruitingInterventional

FORENSIC-UK: Fusion versus Best Conservative Care

Finding relief from severe, ongoing lower back pain can be really difficult for some people. This study, called FORENSIC-UK, wants to find out if a type of surgery called spinal fusion is a better treatment option than other non-surgical treatments, like physiotherapy and painkillers. It's for adults aged 18 to 65 who have had severe back pain for over six months, and where other treatments haven't worked well enough. The study will also look at whether the surgery is a good use of NHS resources. People in the study will either have the surgery or receive a personal plan of non-surgical care.

At a glance

Status

Recruiting

Sponsor

University of Oxford

Enrolment target

270

Start

30 Jun 2025

Estimated completion

30 Sep 2026

Low back pain

What is this study about?

Many of us get back pain at some point, and usually, it gets better on its own or with simple treatments. But for some people, back pain just doesn't go away and becomes a long-term problem. Often, treatments like painkillers, exercises, and physiotherapy (which doctors call 'non-surgical' treatments) can help a lot. However, when these don't work, and the pain is still severe and impacts daily life, doctors sometimes consider an operation called spinal fusion.

This study, called FORENSIC-UK, aims to compare these two approaches for people with this kind of persistent, severe back pain. The main goal is to see if having spinal fusion surgery actually works better in the long run than continuing with the best available non-surgical care. This involves things like tailored exercise plans, pain management, and reviewing medications.

The study also has another important aim: to find out if spinal fusion surgery is a good investment for the NHS. This means looking at whether the benefits of the surgery are worth the cost compared to non-surgical treatments. By doing this research, we hope to understand the best ways to help people in the UK who are suffering from long-lasting, severe lower back pain.

Key takeaways

This study compares surgery to non-surgical treatment for ongoing severe lower back pain.
It's for adults aged 18-65 whose pain hasn't improved with other treatments.
You'll either have spinal fusion surgery or a personalised non-surgical care plan.
The study also looks at whether the surgery is good value for the NHS.
You'll be asked to complete questionnaires over two years to track your progress.
All procedures used in the study are standard NHS practices and considered safe.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old. You must have severe lower back pain that has lasted for at least six months and hasn't really improved with other non-surgical treatments you've tried. Doctors will also need to confirm that either spinal fusion surgery or non-surgical care would be suitable for your condition.

There are also some reasons why you might not be able to join. For example, if your leg pain is worse than your back pain, or if you've had spinal fusion surgery before. Certain mental health conditions or other serious health problems that might need spinal fusion for different reasons (like a tumour or a major spinal injury) would also mean you couldn't take part in this specific study.

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.

Do I have severe lower back pain that has lasted for 6 months or more?
Have I tried other back pain treatments, like physiotherapy or painkillers, that haven't worked well?
Am I between 18 and 65 years old?
Am I generally suitable for either surgery or a non-surgical treatment plan for my back?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly put into one of two groups, like flipping a coin. One group will have spinal fusion surgery, which involves an operation to join some of the bones in your lower back. The other group will receive a personalised plan for non-surgical care. This plan will be put together with you and your doctor and could include looking at your current medicines, exercise advice, ways to manage your pain, and help finding other NHS services.

Whichever group you're in, you'll be asked to fill out questionnaires about your pain and how you're feeling at 6 months, 12 months, and 24 months after you start. You can do these online or on paper, whichever you prefer. Before you join, you might also have scans like an MRI or CT scan to make sure the study is right for you.

Potential risks and benefits

Taking part in this study might mean your back pain gets better, and you might need less physiotherapy or pain relief. However, there's always a chance your pain might not improve. If you have any scans, there's a very low risk from magnetic fields (MRI) or radiation (CT), but these are common, safe procedures. If you have surgery, there are general risks linked to any operation, like bleeding or infection, and risks from the anaesthetic like feeling sick. For those doing more exercise in the non-surgical group, there's a risk of temporary increased pain. It's important to remember you can leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (21)

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

Sheffield Teaching Hospitals NHS Foundation Trust
City only
Sheffield, United Kingdom
Belfast Health and Social Care Trust
City only
Belfast, United Kingdom
The Royal Orthopaedic Hospital NHS Foundation Trust
City only
Birmingham, United Kingdom
University College London Hospitals NHS Foundation Trust
City only
London, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
City only
Coventry, United Kingdom
Milton Keynes University Hospital NHS Foundation Trust
City only
Milton Keynes, United Kingdom
Berkshire Healthcare NHS Foundation Trust
City only
Bracknell, United Kingdom
Whittington Health NHS Trust
City only
London, United Kingdom
Northumbria Healthcare NHS Foundation Trust
City only
Northumberland, United Kingdom
Somerset NHS Foundation Trust
City only
Taunton, United Kingdom
The Royal Wolverhampton NHS Trust
Unverified
Wolverhampton, United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust
Unverified
Derby, United Kingdom

Common questions

What is spinal fusion surgery?

Spinal fusion is an operation where doctors join together some of the bones in your lower back to stop them from moving against each other.

What does 'best conservative care' mean?

This means personalised non-surgical treatments like reviewing your medicines, exercise plans, pain management, and other support tailored to your needs.

Why do I need to be 18-65 years old?

Clinical trials often have age limits to make sure the study is looking at a specific group of people and to ensure safety.

Will I have to pay to be part of the study?

No, the study is funded by the National Institute for Health and Care Research, so you will not have to pay.

What happens if I change my mind?

You are free to leave the study at any point, and choosing to do so will not affect your standard medical care.

How to find out more

Odette Dawkins

odette.dawkins@ndorms.ox.ac.uk +44 (0)7500 072555 Official trial record

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