Clinical trial NCT03670706: Knee Pain Nurse Led Package of CareTrial
Official title: The East-Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility Cohort-randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Pain, Joint
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 1806
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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


Eligibility 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

Primary outcomes:
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: University of Nottingham/ Nottingham University NHS Trust
name: Abhishek Abhishek
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nomikos PA, Hall M, Fuller A, Millar B, Ogollah R, Valdes A, Doherty M, Walsh DA, das Nair R, Abhishek A. Fidelity assessment of nurse-led non-pharmacological package of care for knee pain in the package development phase of a feasibility randomised controlled trial based in secondary care: a mixed methods study. BMJ Open. 2021 Jul 29;11(7):e045242. doi: 10.1136/bmjopen-2020-045242.
citation: Hall M, Fuller A, Nomikos PA, Millar B, Ogollah R, Valdes A, Greenhaff P, das Nair R, Doherty M, Walsh DA, Abhishek A. East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocol. BMJ Open. 2020 Sep 9;10(9):e037760. doi: 10.1136/bmjopen-2020-037760.