Knee Pain Nurse Led Package of CareTrial

Osteoarthritis, Knee Clinical Trial

— Team-KP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670706
• Other study ID #: Team-KP
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: July 5, 2021

Study information

• Verified date: September 2021
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1806
• Est. completion date: July 5, 2021
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Osteoarthritis, Knee
• Pain, Joint

Intervention

Behavioral:
• Exercise
Package of care

Other:
• analgesic optimisation
optimisation

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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