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

September 20, 2021 updated by: University of Nottingham

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

  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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1806

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals Nhs Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Exercise training, then crossover to analgesic optimisation
Behavioral: Exercise
Package of care
Other Names:
  • Package of care
Other: analgesic optimisation
optimisation
Active Comparator: Group B
Analgesic optimisation, then crossover to exercise training
Behavioral: Exercise
Package of care
Other Names:
  • Package of care
Other: analgesic optimisation
optimisation
No Intervention: Group C
Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 26 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Principal Investigator: Abhishek Abhishek, University of Nottingham/ Nottingham University NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2018

Primary Completion (Actual)

July 5, 2021

Study Completion (Actual)

July 5, 2021

Study Registration Dates

First Submitted

September 4, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (Actual)

September 13, 2018

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Team-KP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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