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. 1 IRAS ref: 247370 PROP OA Participant Information Leaflet_v2.0 24-Apr-2019 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 2 IRAS ref: 247370 PROP OA Participant Information Leaflet_v2.0 24-Apr-2019 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. 3 IRAS ref: 247370 PROP OA Participant Information Leaflet_v2.0 24-Apr-2019 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.