A trial of advice, exercise and braces for people with knee pain and knee osteoarthritis
Participant Information Leaflet
You are being invited to take part in a research study called the PROP OA trial. This leaflet explains in detail why the study is being carried out, what is involved and how you can take part. This information will help you decide whether or not you want to take part. Please take time to read this information carefully. You may wish to discuss it with others, such as friends and relatives.
What is the purpose of the study?
Knee pain affects 1 in 4 people aged over 45 years. The most common cause is osteoarthritis, although many people will manage their symptoms without getting the diagnosis. The condition and its symptoms vary a lot from one person to another. It can be difficult coping with pain and other symptoms (particularly sudden, unpredictable episodes), trying to maintain or adapt daily activities, and dealing with frustration and uncertainty about the future. There is no cure for osteoarthritis, but with treatment, symptoms can be improved allowing people to stay active. Wearing a knee brace could help by reducing the load going through the joint and improving its stability. However, there are mixed reports about whether knee braces do actually help. Our goal with this research study is to show whether wearing a knee brace provides more relief for people with painful knee osteoarthritis than having education, advice and exercise instruction alone, and whether this is good value for money for the NHS.
Who is organising and funding the study?
The PROP OA trial is being led by Professor George Peat (Keele University) and other researchers at Keele University, the University of Manchester and Northumbria Healthcare NHS Foundation Trust. They are working in partnership with Keele Clinical Trials Unit (CTU) and with patients, GPs, physiotherapists and other healthcare professionals in Staffordshire, Cheshire, Manchester and Northumbria. The trial is funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (ref: 16/160/03).
Why have I been invited to take part?
We have sent invitations to people aged 45 years and older who have recently consulted their GP about knee pain, and to people of that age who are waiting to see a physiotherapist about knee pain. You may have contacted us after hearing about the study on social media or from other sources.
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Do I have to take part?
No, it is entirely up to you to decide. You will have the opportunity to discuss the study with a member of the research team. If you decide to take part you will be asked to sign a consent form. However, you are free to withdraw at any time and this decision will not affect the care you receive now or in the future. You can withdraw by contacting the study team at Keele CTU on 0800 130 3419 quoting PROP OA. If you decide not to take part, this decision will not affect the care you receive now or in the future.
What would taking part involve?
This diagram outlines what is involved and when. More detail on each of these steps is given on the following pages.
Telephone call with study administrator at Keele CTU
2 weeks before Assessment visit to PROP OA Clinic £
start of trial (lasts roughly 1 hour, longer if knee X-rays need to be taken)
Treatment visit to PROP OA Clinic £ START OF TRIAL (up to 1 hour)
A B Advice, education, exercise Advice, education, exercise instruction instruction + brace
Follow-up treatment visit to 2 weeks later PROP OA Clinic £
3 months later Follow-up questionnaire £ Follow-up questionnaire £
6 months later Follow-up questionnaire £ Follow-up questionnaire £
7 months later Brace check at PROP OA Clinic £
12 months later Follow-up questionnaire £ Follow-up questionnaire £
END OF TRIAL
£ Every time you visit the PROP OA clinic or are sent a questionnaire you will be given a £10 gift voucher to say thank you for your time
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Taking part in the PROP OA trial would involve you: Telephoning the study team on a free telephone number 0800 130 3419. You will be given the opportunity to ask questions about the trial. If you want to take part, you will be asked some questions about yourself to see if you might be eligible to take part. Attending an appointment at a ‘PROP OA Clinic’ in one of the local clinics where the trial is running (Leighton Hospital in Cheshire, Cannock Hospital in Staffordshire, NIHR/Wellcome Trust Adult’s Clinical Research Facility in Manchester and North Tyneside General Hospital in North Shields). You will be seen by a physiotherapist who will examine your knee and complete the checks to see if you are eligible to take part. We will also need a set of knee X-rays. If you have had knee X-rays recently we will try to find these on the hospital computer system. If not, you will have a new set taken that day. As these X-rays are being taken for research purposes we will not routinely send the results to your doctor. However, we will notify your doctor if there are any serious problems identified on the X-rays and let you know we have done this. Your appointment will last approximately 1 hour. You will need to stay for longer if you need new knee X-rays. Coming back to the PROP OA Clinic two weeks later for an appointment lasting up to one hour when you will receive treatment from the physiotherapist. Before your treatment begins we will check your X-rays and you will be asked to sign a consent form. You will be given:
EITHER A: Education, advice on pain management and an exercise programme to complete at home. This involves education about latest knowledge on knee problems and osteoarthritis; advice on pain management techniques; instruction on a home exercise programme; written guidance, including a print out of your exercise programme. You will be encouraged NOT to wear a knee brace for 6 months. OR B: Education, advice on pain management and an exercise programme to complete at home, plus a knee brace. The type of brace that the physiotherapist recommends will be based on their assessment findings and your X-ray and you will have the opportunity to test the brace out. You will be shown how to put the brace on and take it off and how to look after the brace. You will be given written instructions and access to short instructional videos. We will encourage you to keep a diary for the first two weeks about how you are getting on with the brace. Keeping a diary is an optional thing which you do not have to do although it may be helpful for you and the physiotherapist when you come for your follow-up visit. The brace will be provided free of charge. If you are given a brace you will need to return to the PROP OA Clinic for a follow-up appointment 2 weeks later. At this appointment the physiotherapist will check the brace and how much you are wearing it. Over 12 months you will be sent regular text messages from the study team asking about your brace usage. For the first 4 weeks these will be sent weekly, but then they will become gradually less frequent. Some individuals will have a knee brace that is fitted with a small, battery-operated monitor to check how the brace is working. If your brace is fitted with one of these, you will be asked to come back to the PROP OA Clinic 7 months later so it can be removed and we can check the brace.
Please note that whichever treatment you receive, you will be given a £10 gift voucher each time you attend an appointment, as a way of thanking you for your time.
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The appointments with the physiotherapist may be audio-recorded or observed by a member of the study team. This is to help the research team understand how treatments are being delivered. The physiotherapist will ask your permission during the appointment before the audio-recording or observation begins. Completing a questionnaire on knee symptoms, activities and general health. You will be given a questionnaire to complete before you receive treatment. We will then post a questionnaire to you 3 months, 6 months, and 12 months later. You can return these free of charge in stamped addressed envelopes that we will provide. The questionnaires provide vital information for this study and it is important we hear back from as many people as possible, including those where treatment is not working or no longer needed. We think each questionnaire will take about 20-30 minutes to complete. We will send you a £10 gift voucher with each follow-up questionnaire that we send. You can keep the voucher whether or not you complete and return your questionnaire. Being asked for permission to give the research team access to your medical and other health-related records, to understand the longer-term effects of treatment, such as whether knee braces reduce the risk of future knee operations. Being asked for permission for the research team to contact you about an interview study. We would like to interview some people who have taken part in the trial to learn more about their experiences. The interview would last for up to 1 hour and either be completed over the telephone or in your own home. The interview would be audio recorded. You can still take part in the main trial even if you do not want the research team to access your medical records, or do not want to be contacted about an interview.
How would my treatment group be decided?
The decision as to which treatment you follow is made randomly by a computer programme at Keele CTU at Keele University. Like the flip of a coin, you will have an equal chance of being allocated to either treatment. Dividing people in this random way is important because it is the best way to compare treatments fairly. It is important to remember that everyone who takes part in the trial, whichever treatment they receive, is providing an equally valuable contribution.
What are the possible benefits of taking part?
The treatment you receive might help your knee pain and other symptoms. Even if you get no direct benefit from your treatment, taking part in this trial will help us learn more about improving the treatments and care provided to people with knee osteoarthritis.
What are the possible disadvantages and risks of taking part?
Both treatments that are being delivered within this trial are already used in the NHS. However, as with all research studies, there are potential disadvantages and risks to participation. Taking part will impact on your time. All the questions, examinations, and X-rays in this study are already currently used in the NHS to assess knee problems. People with knee problems do occasionally find that even brief physical examination can cause some discomfort although this is short-lasting and does not indicate any underlying change in their condition.
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The X-rays in this study will be extra to those that you would have if you did not take part in this research. These procedures use ionising radiation to provide the physiotherapist with additional information on which parts of the knee appear most affected by osteoarthritis. The radiation doses from X-rays are extremely small in relation to those we receive from natural background radiation. The X-rays in this study are equivalent to an hour of natural background radiation. The additional lifetime risk of developing cancer for each knee X-ray is much less than 1 in a million. Therefore, they are not associated with any significant health risk. In people with knee problems exercise can sometimes cause temporary, mild soreness to the joints. The physiotherapist who is responsible for your treatment will be able to give you advice on how to manage these symptoms. Minor complications related to wearing certain types of knee brace are common. Up to 1 in 10 people wearing a knee brace can get skin irritation, blisters, and swelling. Other complications can include severe skin soreness, broken skin, increased pain, sensation changes in the leg, and circulation problems. The risk of these can often be reduced by correctly fitting the brace and finding the right balance between comfort and wearing the brace often enough to get the benefits. The physiotherapist will advise you on this. Major complications are uncommon or rare although no large-scale study has been done to know exactly how often they happen. Some of the braces will be fitted with a small, battery-operated monitor (¾ inch across, about the size of a watch battery). This is to check that the brace is working properly. There have been no known side effects from these monitoring devices. As some of the braces will be fitted with a battery, we are asking everyone to wipe clean their brace instead of washing it and to keep the brace in a safe place away from pets and small children in case of swallowing. If you are experiencing any unpleasant side effects from the treatments you have received within the trial, or any problems with the monitoring device, please telephone the study team at Keele CTU on Freephone 0800 130 3419 during office hours and quote PROP OA.
What will happen to the information collected about me during the study?
We will be using information from you and your medical records in order to undertake this study. Keele University is the sponsor for this study and will act as the data controller. This means that Keele University is responsible for looking after your information and using it properly. They will keep identifiable information about you for 10 years after the study has finished. Your rights to access, change or move your information are limited. This is because we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible. You can find out more about how we use your information at: www.keele.ac.uk/informationgovernance/informationgovernanceforthepublic/ Your GP and physiotherapy service will collect information from you and your medical records for this research study in accordance with our instructions. Your local hospital and Keele CTU will use your name and contact details to contact you about the research study. They will make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Authorised individuals from Keele University and regulatory organisations may look at your medical and research records to check the accuracy of the research study.
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On joining the study, your information will be securely stored under a unique study number. Your questionnaire answers (data) will only be associated with this number, not your personal details. Your consent form, containing your personal identifiable details, will also be stored securely at Keele University but separately to your data. Our procedures for handling, processing, storage of and destruction of data are in line with relevant regulatory requirements. To ensure data are stored securely, it will be held on networks approved by a government backed cyber security scheme. If you give permission, the research team will link information that you provide us within the study with data routinely held and maintained by the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man, and by NHS Digital. To do this we would use an NHS identifier such as your NHS number (or equivalent), name and date of birth to link and pull your data from these registries. This linking information will be stored securely for 10 years after the end of the study. Any information received in this way remains confidential and is used only for the purposes of this particular study. If you agree to take part in an interview, the audio-recording will be typed out to make a paper copy of the discussion (called an interview transcript). This will be carried out by a professional transcription company who operate under strict terms of confidentiality. The transcript will then be anonymised. Both the audio-recording and the paper transcript will be stored securely and will be kept for 10 years after the study has finished. The only people in Keele University who will have access to information that identifies you will be people who need to contact you about the study or audit the data collection process. The people who analyse the information will not be able to identify you or find out your name or contact details. Your identifiable data will be securely stored by Keele CTU at Keele University and will not be used beyond these purposes. To ensure continuing care, we will inform your GP of your participation in this study. Your local hospital will keep identifiable information about you from this study in line with local procedures, which may be for 10 years after the study has finished. When you agree to take part in a research study, anonymous information about your health and care (i.e. information that will not identify you) may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your anonymous information will only be used for research that is conducted in accordance with the UK Policy Framework for Health and Social Care Research: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy- framework-health-social-care-research/ This anonymised information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.
What will happen at the end of the study?
After the study has finished and we have reviewed the results, the main findings will be shared with the hospital sites, GP practices and physiotherapy services involved in the study. They will also be available on the PROP OA website www.keele.ac.uk/propoa, and in places where the trial was advertised in the community. The results of this study will be shared at medical conferences and through publication in academic journals which are read by a large number of health professionals. You will not be identified individually in any poster, report or publication.
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Who has reviewed the study?
This study has been independently reviewed as part of the funding application and by Keele University as the study sponsor. The study has also been reviewed and approved for conduct in the NHS by the North West – Preston Research Ethics Committee (REC reference: 19/NW/0183).
Contact for further information
Please visit our website at www.keele.ac.uk/propoa. If you have any questions, would like further information, or you would like to take part, please contact the study team at Keele Clinical Trials Unit during office hours on Freephone 0800 130 3419. Any queries can also be addressed to Keele Clinical Trials Unit (CTU), David Weatherall Building, Keele University Staffordshire, ST5 5BG. If you have any concerns or complaints about this study, please contact the Sponsor Representative at Keele University, Head of Project Assurance on 01782 734714 or [email protected].
Thank you for reading this information and for considering taking part in this study.
If you would like to be involved in this study please call the study team at Keele Clinical Trials Unit on Freephone 0800 130 3419 and quote PROP OA. Calling does not mean that you have to take part.
This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (Grant Reference Number HTA 16/160/03). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
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