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Trial record 1 of 1 for:    NCT03670706
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Knee Pain Nurse Led Package of CareTrial (Team-KP)

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ClinicalTrials.gov Identifier: NCT03670706
Recruitment Status : Unknown
Verified February 2019 by University of Nottingham.
Recruitment status was:  Recruiting
First Posted : September 13, 2018
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

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

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Pain, Joint Behavioral: Exercise Other: analgesic optimisation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The East-Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility Cohort-randomised Controlled Trial
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Group A
Exercise training, then crossover to analgesic optimisation
Behavioral: Exercise
Package of care
Other Name: Package of care

Other: analgesic optimisation
optimisation

Active Comparator: Group B
Analgesic optimisation, then crossover to exercise training
Behavioral: Exercise
Package of care
Other Name: Package of care

Other: analgesic optimisation
optimisation

No Intervention: Group C
Control group



Primary Outcome Measures :
  1. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670706


Contacts
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Contact: Bonnie Millar 0115 8231754 bonnie.millar@nottingham.ac.uk
Contact: Abhishek Abhishek 0115 8231754

Locations
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United Kingdom
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Bonnie Millar    0115 8231676    bonnie.millar@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Abhishek Abhishek University of Nottingham/ Nottingham University NHS Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03670706    
Other Study ID Numbers: Team-KP
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Arthralgia
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs