Knee Pain Cohort Randomised Controlled Trial

  • Research type

    Research Study

  • Full title

    The East-Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility cohort-randomised controlled trial

  • IRAS ID

    249044

  • Contact name

    Abhishek Abhishek

  • Contact email

    abhishek.abhishek@nottingham.ac.uk

  • Sponsor organisation

    University of Nottingham

  • ISRCTN Number

    ISRCTN00000000

  • Clinicaltrials.gov Identifier

    NCT00000000

  • Clinicaltrials.gov Identifier

    0000, NA

  • Duration of Study in the UK

    2 years, 0 months, 1 days

  • Research summary

    Osteoarthritis (OA) is a very common condition and the knee is one of the most frequently affected joints. Knee osteoarthritis results in pain, stiffness and disability. Despite being common, people with knee OA often receive no, or only fragmented treatment in primary care. The much-needed advice around exercise, physical activity and weight-loss, or referral to physiotherapy frequently does not occur, and there is no single person who coordinates the care of people with OA. The purpose of this study is to develop a nurse-led package of care for people with knee pain due to OA. To do this we first need to develop the package, train the nurse who will deliver it and test to see if it will work in principle.

    We will develop a Package of Care based on current NICE guidelines. We have already consulted with patients and the public as to the content and delivery of the package of care to ensure it fits well with the local setting and adapt accordingly.

    After training the nurses to deliver the package, we will test how well the overall treatment can be delivered to 15-20 patients. Sessions will be videoed in order to review how closely the nurse delivered the content to what was intended. Acceptability of the package will be determined by interviewing the participants (nurses and patients) at this stage.

    Having developed the package of care we will conduct a feasibility study to test:
    • how satisfied patients are with the overall package
    • whether there is any benefit to giving more pain relief ahead of exercise treatments
    • whether a large trial could be carried out by examining our recruitment methods, how many people stay in the trial, the outcomes we use and how many people we will need for a definitive trial

  • REC name

    East Midlands - Derby Research Ethics Committee

  • REC reference

    18/EM/0288

  • Date of REC Opinion

    13 Nov 2018

  • REC opinion

    Further Information Favourable Opinion