What does taking part involve?
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, Victoria Infirmary in Nortwhich, Haywood Hostpial 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:
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.
B: Education, advice on pain management and an exercise programme to complete at home, plus a knee brace.
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 6 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.
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. The brace will be provided free of charge.
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.
- 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. You will receive a £10 gift voucher for each follow-up questionnaire you are sent.
- 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.
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.
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.
- 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 and quote PROP-OA.