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CompletedNCT03670706Team-KPUpdated Sep 21, 2021

Knee Pain Nurse Led Package of CareTrial

An interventional study of Exercise and analgesic optimisation in Osteoarthritis, Knee and Pain, Joint, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-21.

Sponsored by University of Nottingham · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
1,806
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Osteoarthritis, Knee
  • Pain, Joint
03

In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's enrollment of 1,806 is above the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
1,806 participants (actual)

Study arms

  • Active comparator
    Group A

    Exercise training, then crossover to analgesic optimisation

    Behavioral: Exercise · Other: analgesic optimisation

  • Active comparator
    Group B

    Analgesic optimisation, then crossover to exercise training

    Behavioral: Exercise · Other: analgesic optimisation

  • No intervention
    Group C

    Control group

Interventions

  • BehavioralExercise

    Package of care

    Also known as: Package of care

  • Otheranalgesic optimisation

    optimisation

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 26 weeks

07

Study locations

1 site
  • Nottingham University Hospitals NHS Trust
    Nottingham, NG5 1PB, United Kingdom
08

References and documents

Publications

  • 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. PubMed 34326044 ↗
  • 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. PubMed 32912951 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03670706
Lead sponsor
University of Nottingham
Responsible party
Sponsor
First posted
Sep 13, 2018
Start date
Nov 26, 2018
Primary completion
Jul 5, 2021
Completion
Jul 5, 2021
Last update
Sep 21, 2021

Study contacts

Abhishek Abhishek
principal investigator · University of Nottingham/ Nottingham University NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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