Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1806 participants
INTERVENTIONAL
2018-11-26
2021-07-05
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Group A
Exercise training, then crossover to analgesic optimisation
Exercise
Package of care
analgesic optimisation
optimisation
Group B
Analgesic optimisation, then crossover to exercise training
Exercise
Package of care
analgesic optimisation
optimisation
Group C
Control group
No interventions assigned to this group
Interventions
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Exercise
Package of care
analgesic optimisation
optimisation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
Yes
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Abhishek Abhishek
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham/ Nottingham University NHS Trust
Locations
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Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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References
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Fuller A, Hall M, Nomikos PA, Millar B, Ogollah R, Valdes A, Greenhaff P, das Nair R, Doherty M, Walsh DA, Abhishek A. Feasibility of conducting a cohort randomized controlled trial assessing the effectiveness of a nurse-led package of care for knee pain. Rheumatology (Oxford). 2024 May 3;63(6):1582-1592. doi: 10.1093/rheumatology/kead432.
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.
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.
Other Identifiers
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Team-KP
Identifier Type: -
Identifier Source: org_study_id
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