Knee Pain Nurse Led Package of CareTrial

Overview

1. To develop a training package for nurse-led management of knee osteoarthritis (OA), incorporating information about OA and core non-pharmacologic and pharmacologic principles of management of OA as recommended in the National Institute for Clinical Excellence and Health (NICE) guidelines for management of OA 2. To evaluate fidelity of delivery of individual components of this complex package of care for knee pain 3. To assess the acceptability of the intervention by exploring participant satisfaction with nurse-led complex package of care of knee pain. 4. To explore and resolve possible challenges to delivery of individual components within a complex package 5. To examine the feasibility of a definitive cohort randomised controlled trial of nurse-led care versus usual care of knee pain in terms of recruitment rate, drop-out rate, reasons for dropping out and completeness of outcome data 6. To explore whether such a trial should provide analgesia before non-pharmacologic interventions or vice versa

Full Title of Study: “The East-Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility Cohort-randomised Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 1, 2020

Interventions

  • Behavioral: Exercise
    • Package of care
  • Other: analgesic optimisation
    • optimisation

Arms, Groups and Cohorts

  • Active Comparator: Group A
    • Exercise training, then crossover to analgesic optimisation
  • Active Comparator: Group B
    • Analgesic optimisation, then crossover to exercise training
  • No Intervention: Group C
    • Control group

Clinical Trial Outcome Measures

Primary Measures

  • The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
    • Time Frame: 26 weeks
    • questionnairehe Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties

Participating in This Clinical Trial

Inclusion Criteria

  • Knee pain on most days of the previous month – At least moderate pain on two of the five WOMAC knee pain domains in the most painful knee – Knee pain present for longer than 3 months Exclusion Criteria:
  • • House-bound or care home resident

  • Dementia – Dialysis – On home oxygen – Serious mental illness – Inability to communicate in English – Unable to give consent – Terminal cancer – Known diagnosis of autoimmune rheumatic diseases or psoriasis – Knee or hip replacement, or on waiting list for knee or hip replacement – Asthma or COPD requiring regular daily oral corticosteroids – Unstable angina or heart failure – Known peripheral vascular disease – Pregnant
  • Gender Eligibility: All

    Minimum Age: 40 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • University of Nottingham
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Abhishek Abhishek, Principal Investigator, University of Nottingham/ Nottingham University NHS Trust
    • Overall Contact(s)
      • Bonnie Millar, 0115 8231754, bonnie.millar@nottingham.ac.uk

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