Frequently asked questions

It is up to you to decide whether or not to take part. Your involvement is purely voluntary.  If you do decide to take part, you will still be free to withdraw from the study at any time, without giving a reason and withdrawing will not affect your current or future health care in any way.

If you do not want to take part, or are unable to take part, you will be advised to seek help and advice from either your GP, or from your physiotherapist. You will then be offered the same treatment and advice as you would normally receive.   

No. The study treatment given to you will be chosen at random, which is done using a computer so it is purely by chance. This means that you will have an equal chance of getting either of the treatment packages on offer. 

Please wear comfortable clothing and bring a pair of shorts that you can change into when you are there. 

No, you can live anywhere in the UK and take part, as long as you are willing to attend one of the clinic sites below for up to 4 appointments.  Every time you attend a clinic appointment you will receive a £10 gift voucher, to say thank you for your time. Unfortunately, we cannot reimburse actual out of pocket travel expenses.

Haywood Hospital (High Lane, Stoke on Trent, ST6 7AG)

Leighton Hospital, Crewe (Middlewich Rd, Crewe CW1 4QJ)

Victoria Infirmary, Northwich (Cheshire, CW8 1AW)

NIHR/Wellcome Trust Adult’s Clinical Research Facility, Manchester (Grafton St, Manchester, M13 9WL)

North Tyneside General Hospital (Rake Lane, Tyne and Wear, North Shields, NE29 8NH)

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.

There are no specific risks with Best Primary Care, other than the temporary soreness that can follow starting a new exercise programme.

 

Although we cannot reimburse you for travel and car parking costs that you may have to pay for attending clinic appointments, you will receive a £10 gift voucher every time you come to the clinic to say thank you for your time.

Every time you receive a follow-up questionnaire (at 3 months, 6 months and 12 months after you have entered the trial), you will receive a £10 gift voucher as a thank you for your time.

Even if you no longer have any pain, we would still like you to complete the questionnaire. The information that you provide will allow us to fully understand which treatment is best.

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, 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.

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).

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).

You will have the chance to talk to the study team on the telephone, and the PROP-OA physiotherapist during your face-to-face clinic appointments. However, if in the meantime you have any questions, or would like further information about this study, please contact the us on 0800 130 3419 during office hours.

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 research.governance@keele.ac.uk