Chris Pope, Patient

Dr Martin Thomas, Principal Investigator

What is the purpose of this study?

Study Background

  • Roughly 1 in 4 people aged over 40 years has painful knee joints.
  • Although it is often simply put down to ‘getting older’ or ‘wear and tear’, recent research suggests it is more complex than this.
  • Many people find their pain goes through good and bad periods.
  • This research study is particularly concerned with flare-ups of knee pain that come on suddenly and last at least a day. When they happen, they can seriously disrupt people’s day-to-day lives and can be very frustrating, upsetting or distressing. There is currently little evidence on which to base sound advice to patients and healthcare professionals on how to predict and manage these flare-ups.

Study Aim

Researchers at Keele University are trying to find what causes people to have flare-ups of their knee pain so that we can help patients and their GP work together to better understand and manage common knee problems. We particularly want you to help us understand things that might cause them to have flare-ups.

What will I have to do, and how long will it take?

If you agree to provide us with your name and email address we will use this to send you questionnaires to complete over a 13 week period (see below) and give you access to the ACT-FLARE website. If you agree to provide a mobile phone number we will be able to send you fortnightly text reminders to tell us if you have had a flare-up. Through links to the study website we would like to collect information from you in the following stages:

  • Completion of an on-line consent form.
  • Completion of an on-line questionnaire about your knee pain and some general aspects of health after you have provided consent.
  • Each month you will be invited to complete follow-up questionnaires via a link to the ACT-FLARE website about your knee pain in the last 3 days regardless of whether you are experiencing knee pain or not at the time.
  • In addition, we will be asking you to notify us through the website if and when you experience a flare-up of your knee pain at any point over the 13 weeks of the study. If this happens, we will email you a web link to a further questionnaire asking about your activities during the 3 days before the flare-up. We will also invite you to provide some brief information via a link to the ACT-FLARE website each day until your flare-up ends and your symptoms return to ‘normal’ for you.
  • At the end of the study we will invite you to complete a very short 2 question questionnaire that may help us develop further research studies.
  • Questionnaires will take approximately 15 minutes to complete.

What do we mean by a flare-up of knee pain?

Flare-ups are an event that:

  • causes an increase in your pain that is beyond normal day-to-day variation that lasts for a period of time
  • comes on suddenly, developing over minutes or hours (rather than a very gradual worsening over days or weeks)

Not everyone is affected in the same way by flare-ups. These are some things that people say they can feel when they have a flare-up. You may experience some, none, or all of these during your flare-ups:

  • everyday activities are more difficult or impossible to do
  • they need to take (more) painkillers
  • limping
  • swelling of the joint
  • more stiffness of the joint
  • pain that disturbs your sleep.

You are invited to notify us each time you experience a flare-up during the study no matter how many times you experience one.

It is also important for us if you continue with the routine questionnaires throughout the study even if you do not experience a flare-up or any further knee pain at all during this period.

Information and on-going support will be provided for accessing the website as needed.

Who is funding and organising the research?

This research is funded by the Health Education England(HEE) and the National Institute for Health Research (NIHR) through an Integrated Clinical Academic Clinical Lectureship (ICA-CL-2016-02-014). Support is being given by the NIHR Clinical Research Network. The Keele Clinical Trials Unit and Arthritis Research UK Primary Care Centre within the Research Institiute for Primary Care & Health Sciences, Keele University are organising this research.

Who has reviewed the study?

All research carried out within the NHS is assessed by an independent group of people, called a Research Ethics Committee, to protect your safety, rights, well-being and dignity. This study has been reviewed by Yorkshire & The Humber - Leeds East Research Ethics Committee (Research Ethics Committee Reference Number: 18/YH/0075).