We would like to invite you to take part in our research study. Before you decide, it is important that you understand why the research is being done and what it would involve for you.
Low back pain is common for many people and often improves without specific treatment however some medical professionals including doctors, nurses and physiotherapists think that ‘wear and tear’ may be the cause of on-going low back pain (or may contribute to it) and that an operation called ‘spinal fusion’ may help.
FORENSIC-UK is a research study that has been designed by a team of spinal surgeons, physiotherapists, patients, pain specialists, researchers, statisticians, and health economists from several universities and hospitals. It is designed to see if, in a carefully selected group of people with ongoing low back pain, they can benefit from either Spinal Fusion Surgery or from a personalised non-surgery treatment plan.
This non-surgical treatment will be specially created for the patient and is an enhancement of the treatment patients’ may have already had. It includes looking and adjusting an individual’s medication, exercise and pain control management plans. We call this Best Conservative Care.
We currently do not know if treating low back pain with surgery is better than using non-surgical treatment for patients. By taking part you will be helping answer this important research question.
What happens if I decide to take part?
To take part you have to be contacted by a Hospital that is participating in the FORENSIC-UK study or by making contact with a Hospital that is participating in the study.
If you decide to take part, you’ll be asked to sign a consent form to confirm you are happy to participate and you should feel comfortable accepting either Spinal Fusion Surgery or Best Conservative Care.
The treatment that you are allocated to will be decided by what we call randomisation which means you will have an equal chance (50:50) of receiving either Spinal Fusion Surgery or Best Conservative Care. The randomisation process is done electronically and no one can influence the outcome or know beforehand what the result will be.
If you are put into (allocated) the Spinal Fusion Surgery Group:
The NHS Hospital Trust which you are in will oversee your Spinal Fusion Surgery and you will be seen by a Consultant Spinal Surgeon.
- You will have the operation under general anaesthetic.
- You may be in hospital between 3-5 days.
- Your clinical care will include before and after surgery consultations with your surgeon who will go through the type of fusion surgery they will perform as this is specific to each hospital and surgeon.
- You will have x-rays during and after surgery (a type of radiation image of the bones inside of the body)
- You will have clinical appointments (some appointments maybe by telephone) as part of the usual clinical care for surgery.
- Your post-operative care will include rehabilitation sessions using techniques to help manage any pain and help you to return to daily activities. This is part of the usual clinical care for surgery.
- We will invite you to have a CT scan 2 years after randomisation as part of the research study. We will use this scan for information only. (You will only be contacted about your scan if a doctor thinks it is medically important that any findings from the scan have clear implications about your current or future health).
If you are put into (allocated) the Best Conservative Care Group:
You will be seen by a senior spinal practitioner - usually a senior physiotherapist who will perform a detailed assessment of your needs and together with you as the patient, design a personalised treatment plan based on your previous care, your goals and expectations. This personalised plan is different from the standard care available as it will recognise that each person is different, and the treatment will be tailored accordingly.
The treatment plan will include at least one of the following:
- A course of physiotherapy including an individualised exercise plan.
- Support for active self-management, this may include exercise or lifestyle advice.
- A pain management programme with different elements which usually include, exercise, advice (for examples more suitable pain medication), specialist physiotherapy, and psychological support.
- Radiofrequency ablation/denervation – this is a non-surgical procedure to stop the nerves in your lower back sending pain signals to your brain.
A programme of rehabilitation which uses a combination of psychological techniques to help you get through pain, become fitter and return to daily activities
Is it safe to take part in a study?
All procedures in this study are known in the NHS and deemed safe
All procedures in this study are known in the NHS and deemed safe
Please read the Participation information Sheet (PIS), as this gives even more details about taking part in this study. Link is found here: Participant Information Sheet (PIS) (V3.0) and on the Trial Information Page on this website.
