Osteoarthritis, KneeTeam-KPNCT03670706
Knee Pain Nurse Led Package of CareTrial
A study testing Exercise and analgesic optimisation in people with Osteoarthritis, Knee and Pain, Joint, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Pain, Joint
- What is being tested?
- Exercise and analgesic optimisation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,806 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Nov 2018to 5 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Dementia
- Dialysis
- On home oxygen
- Serious mental illness
- Inability to communicate in English
- Unable to give consent
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
About this study
Official title: The East-Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility Cohort-randomised Controlled Trial
- 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
- Conditions
- Osteoarthritis, Knee, Pain, Joint
- Being tested
- Exercise, analgesic optimisation
- Medical subject headings
- Osteoarthritis, Knee, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Package of care
Package of care
analgesic optimisationOther
optimisation
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Exercise training, then crossover to analgesic optimisation Receives: Behavioral: Exercise; Other: analgesic optimisation |
| Group B | Active comparator | Analgesic optimisation, then crossover to exercise training Receives: Behavioral: Exercise; Other: analgesic optimisation |
| Group C | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start26 Nov 2018
- Primary completion5 Jul 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,806 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abhishek Abhishek, Principal investigator, University of Nottingham/ Nottingham University NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670706
- Sponsor's protocol ID
- Team-KP
- Acronym
- Team-KP
- Status last verified
- Sep 2021
- First submitted
- 4 Sep 2018
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37610332Nomikos 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 34326044Hall 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The East-Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility Cohort-randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03670706
- Acronym / sponsor ID
- Team-KP / Team-KP
- Conditions
- Osteoarthritis, Knee, Pain, Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,806 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Behavioral: Exercise, Other: analgesic optimisationExercise training, then crossover to analgesic optimisation |
| Group B | Active comparator | Behavioral: Exercise, Other: analgesic optimisationAnalgesic optimisation, then crossover to exercise training |
| Group C | No intervention | –Control group |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- Dementia
- Dialysis
- On home oxygen
- Serious mental illness
- Inability to communicate in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Package of carePackage of care | Behavioural | Group A, Group B |
| analgesic optimisationoptimisation | Other | Group A, Group B |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Derived from this study: PubMed 37610332Fuller 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.
- Derived from this study: PubMed 34326044Nomikos 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.
- Derived from this study: PubMed 32912951Hall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhishek Abhishek principal investigator
University of Nottingham/ Nottingham University NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and analgesic optimisation in people with Osteoarthritis, Knee and Pain, Joint, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03670706, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.