Knee Pain Nurse Led Package of CareTrial (Team-KP)

University of Nottingham

Status: Completed

Conditions: Pain, Joint; Osteoarthritis, Knee

Treatments: Behavioral: Exercise; Other: analgesic optimisation

Study type: Interventional

Funder types: Other

Identifiers

NCT03670706

Team-KP

Details and patient eligibility

About

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

Enrollment: 1,806 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,806 participants in 3 patient groups

Group A

Active Comparator group

Description:

Exercise training, then crossover to analgesic optimisation

Treatment:

Behavioral: Exercise

Other: analgesic optimisation

Group B

Active Comparator group

Description:

Analgesic optimisation, then crossover to exercise training

Treatment:

Behavioral: Exercise

Other: analgesic optimisation

Group C

No Intervention group

Description:

Control group