Knee Pain Nurse Led Package of CareTrial

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

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Key information

Conditions

Osteoarthritis, Knee Arthralgia Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pain, Joint Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Package of care

Other names: Package of care

analgesic optimisation

Other

optimisation

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

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

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

Acronym: Team-KP

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Sep 13, 2018
Registry last updated: Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed