Knee Pain Nurse Led Package of CareTrial

NCT ID: NCT03670706

Last Updated: 2021-09-21

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1806 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2021-07-05

Brief Summary

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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

Detailed Description

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Conditions

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Osteoarthritis, Knee Pain, Joint

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group A

Exercise training, then crossover to analgesic optimisation

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

Package of care

analgesic optimisation

Intervention Type OTHER

optimisation

Group B

Analgesic optimisation, then crossover to exercise training

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

Package of care

analgesic optimisation

Intervention Type OTHER

optimisation

Group C

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Package of care

Intervention Type BEHAVIORAL

analgesic optimisation

optimisation

Intervention Type OTHER

Other Intervention Names

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Package of care

Eligibility Criteria

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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

* 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United Kingdom

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.

Reference Type DERIVED
PMID: 37610332 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34326044 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32912951 (View on PubMed)

Other Identifiers

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Team-KP

Identifier Type: -

Identifier Source: org_study_id

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