The East-Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility Cohort-randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Nottingham
- Enrollment
- 1,806
- Locations
- 1
- Primary Endpoint
- The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Study Overview
Brief Summary
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
Group A
Exercise training, then crossover to analgesic optimisation
Intervention: Exercise (Behavioral)
Group A
Exercise training, then crossover to analgesic optimisation
Intervention: analgesic optimisation (Other)
Group B
Analgesic optimisation, then crossover to exercise training
Intervention: Exercise (Behavioral)
Group B
Analgesic optimisation, then crossover to exercise training
Intervention: analgesic optimisation (Other)
Group C
Control group
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported