Information for Patients and Participants

What is the purpose of the trial?

The BOOST trial is studying the physiotherapy treatment of back and leg pain or symptoms due to lumbar spinal stenosis (also called neurogenic claudication). This is a condition that affects older people and limits their ability to walk and stand which impacts on their ability to remain independent.

There is little research to help us know what type of physiotherapy is best for people with symptoms due to lumbar spinal stenosis.

Therefore, we are testing two different approaches to physiotherapy which have been designed to help older adults with symptoms of lumbar spinal stenosis to stay mobile and remain independent. We are hoping to recruit over 400 adults to join the trial, and we will be working with at least 10 NHS hospitals across England. See if your local hospital is supporting the trial.

Who is taking part?

We are looking for people aged 65 years and over who experience symptoms due to lumbar spinal stenosis. Lumbar spinal stenosis is an age-related narrowing of the spinal canal which places pressure on the nerves and blood vessels causing pain, weakness, numbness, tingling or cramping of the lower back, buttocks or legs. You may have been invited to take part in the trial because you have reported these types of symptoms which indicate that you may be eligible.

We are testing two different approaches to physiotherapy which have been designed to help older adults with symptoms of lumbar spinal stenosis to stay mobile and remain independent. 

Can I take part if I haven't already been invited?

Patients attending physiotherapy and spinal clinics at participating hospitals are potentially eligible.  If you are interested in participating and you think that you might be eligible, please speak to your physiotherapist or consultant to find out if they are supporting the trial. Unfortunately patients are not able to self-refer into the trial. 

Do I have to take part in the trial?

No, you do not have to take part in the trial. If you do decide to take part, you may also change your mind without telling us why. You can withdraw from the trial at any time. Your decision will not make any difference to the medical care you receive.

What will taking part involve?

If you are invited to take part in the trial, and you decide that you are interested, you will be invited to attend an assessment appointment at your local hospital. This appointment will take up to 1 ½ hours. A researcher will carry out some simple assessments to check whether you are eligible for the trial. If you are eligible and you decide that you would like to take part, you will be asked to sign and date a consent form and then complete a questionnaire. We will also carry out a physical assessment. 

As part of this research we are also taking participants' spinal measurements from an MRI scan, to help us understand how different patients respond to treatment. If you have had an MRI scan in the last 12 months then we will request a copy of the scan from the hospital. If you have not had an MRI scan then we will refer you for a scan at the radiology department of the hospital where you attended the appointment with the researcher. This scan is being done for research purposes. We will collect all the scans from trial participants and then they will be examined by a doctor who is part of the research team. If the doctor taking the measurements of your spine finds a serious problem then we will contact your GP immediately. Otherwise, you are able to request the scan results when the trial is completed.

You will be allocated to one of two treatments - a computer randomly selects which treatment you will receive. This decision is not made by the researcher or physiotherapist and you will not be able to choose which treatment they receive. The researcher will send a referral for treatment to the participating physiotherapy department. You will be told which treatment you are to receive when you attend for your physiotherapy appointment. Physiotherapy treatment will be provided by fully trained NHS physiotherapists at a participating centre in your local area.

 

There are two possible treatments:

TREATMENT 1: One-to-one physiotherapy treatment (1 to 3 appointments)

TREATMENT 2: A group physiotherapy programme (12 classes)

TREATMENT 1: One-to-one physiotherapy treatment (1 to 3 appointments)

TREATMENT 2: A group physiotherapy programme (12 classes)

 

What treatment will I receive?

We are testing out two different ways of delivering physiotherapy treatment. Everybody will attend a one hour appointment and the physiotherapist will assess your symptoms, general health and exercise ability. You will receive advice on exercises and education about lumbar spinal stenosis and the ways you can help manage your symptoms. You will be given a physiotherapy advice booklet. You will be asked to do exercises at home.

A researcher may visit while you are having treatment so that we can check how the treatments are being delivered. We may record some of the treatment sessions to allow checks to be done. We will always check you are happy for this to happen.  At the end of the study, we will report how well treatments were delivered as it is important we understand this.

If you are allocated to Treatment 1 then the physiotherapist will discuss with you if further appointments are necessary. If you are allocated to Treatment 2 then the physiotherapist will tell you about the classes in more detail and when you need to attend. Each class lasts for 1 ½ hours and you will do exercises and take part in group discussions about ways to manage your symptoms and be more physically active.

What happens after I have attended for treatment?

You will be invited to attend two appointments with the researcher at your local hospital (6 and 12 months after your first appointment with the researcher) so we can find out if the treatment has helped or not. We will ask you to complete a questionnaire that asks about your symptoms, health and well-being. We will also ask you about any appointments you have had at the hospital or GP practice and do a physical assessment. The appointment will take approximately 1 hour.

You will receive a questionnaire in the post approximately 2 years after your initial appointment with the researcher. We ask that you complete and return this to the Research team in the stamped addressed envelope provided.  We will remind you with a letter and via telephone if you do not return your questionnaires.

As part of this research we may want to look at information held by the NHS and from sources maintained by the Health and Social Care Information Centre and other central UK NHS bodies. We will only look at information that is relevant to this research. We will only do this if you are happy for us to access this information and it will only be accessed by authorised individuals from the Research team.

All data collected as part of the trial will be processed according to the Data Protection Act 1998, details of which can be found here.

BOOST Interview study

As part of the BOOST trial we will also interview a number of participants, to better understand their experiences of living and ageing with back and leg pain due to lumbar spinal stenosis. You can find out more about the interview study here.

 

Read more about participating in the BOOST trial in the sections below:

Expenses and payments

What are the benefits and risks of taking part in the trial?

Who will know that I am taking part?

Will my details be kept confidential?

What happens at the end of the trial?

Who is organising and funding the research?

What if I have any concerns?

 

If you have any questions about the trial you can contact the Research team at University of Oxford.