Knee Pain Nurse Led Package of CareTrial

Study Overview
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Brief Summary
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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 To evaluate fidelity of delivery of individual components of this complex package of care for knee pain To assess the acceptability of the intervention by exploring participant satisfaction with nurse-led complex package of care of knee pain. To explore and resolve possible challenges to delivery of individual components within a complex package 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 To explore whether such a trial should provide analgesia before non-pharmacologic interventions or vice versa

Official Title
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The East-Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility Cohort-randomised Controlled Trial

Conditions
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Osteoarthritis, Knee, Pain, Joint

Intervention / Treatment
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* Behavioral: Exercise
* Other: analgesic optimisation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Exercise training, then crossover to analgesic optimisation | Behavioral: Exercise<br>* Package of care<br>* Other names: Package of care;Other: analgesic optimisation<br>* optimisation<br>|
| Active Comparator: Group B<br>Analgesic optimisation, then crossover to exercise training | Behavioral: Exercise<br>* Package of care<br>* Other names: Package of care;Other: analgesic optimisation<br>* optimisation<br>|
| No Intervention: Group C<br>Control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 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 | 26 weeks |