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Knee Pain Nurse Led Package of CareTrial (Team-KP)

Primary Purpose

Osteoarthritis, Knee, Pain, Joint

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise
analgesic optimisation
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nottingham University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Group A

Group B

Group C

Arm Description

Exercise training, then crossover to analgesic optimisation

Analgesic optimisation, then crossover to exercise training

Control group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 4, 2018
Last Updated
September 20, 2021
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT03670706
Brief Title
Knee Pain Nurse Led Package of CareTrial
Acronym
Team-KP
Official Title
The East-Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility Cohort-randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
July 5, 2021 (Actual)
Study Completion Date
July 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 To evaluate fidelity of delivery of individual components of this complex package of care for knee pain To assess the acceptability of the intervention by exploring participant satisfaction with nurse-led complex package of care of knee pain. To explore and resolve possible challenges to delivery of individual components within a complex package 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 To explore whether such a trial should provide analgesia before non-pharmacologic interventions or vice versa

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Pain, Joint

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1806 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Exercise training, then crossover to analgesic optimisation
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Analgesic optimisation, then crossover to exercise training
Arm Title
Group C
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
Package of care
Intervention Description
Package of care
Intervention Type
Other
Intervention Name(s)
analgesic optimisation
Intervention Description
optimisation
Primary Outcome Measure Information:
Title
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhishek Abhishek
Organizational Affiliation
University of Nottingham/ Nottingham University NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34326044
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.
Results Reference
derived
PubMed Identifier
32912951
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.
Results Reference
derived

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Knee Pain Nurse Led Package of CareTrial

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