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TEAM-KP: Nurse-led Package of Care for Knee Pain

The East-Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility cohort-randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15464143
Enrollment
2500
Registered
2020-02-10
Start date
2018-12-01
Completion date
Unknown
Last updated
2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee arthritis Musculoskeletal Diseases Gonoarthrosis

Interventions

A package of care will be developed based on current NICE guidelines and on consultation with patients and the public as to the content and delivery of the package of care to ensure it fits well with
will teach them specific exercises that meet their needs
and will explain to them the lifestyle and other changes they can make to improve their knee pain and osteoarthritis and direct them to the appropriate services as required. Over a 3-month period she/

Sponsors

University of Nottingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Knee pain on most days of the previous month 2. Pain rated 4-7 on the pain numeric scale (with 0 being no pain and 10 being as bad as it could be) 3. Knee pain present for longer than 3 months 4. Aged 40 or more years

Exclusion criteria

Exclusion criteria: 1. House-bound or care home resident 2. Dementia 3. Dialysis 4. On home oxygen 5. Serious mental illness 6. Inability to communicate in English 7. Unable to give consent 8. Terminal cancer 9. Known diagnosis of autoimmune rheumatic diseases or psoriasis 10. Knee or hip replacement, or on waiting list for knee or hip replacement 11. Asthma or COPD requiring regular daily oral corticosteroids 12. Unstable angina or heart failure 13. Known peripheral vascular disease 14. Pregnant

Design outcomes

Primary

MeasureTime frame
Osteoarthritis symptoms measured using the WOMAC score at 26 weeks

Secondary

MeasureTime frame
Collected at baseline, week 1, week 13, week 26 visits, and follow-up unless noted otherwise: 1.1. WOMAC (Osteoarthritis symptoms) 1.2. SF-36 V2 (General Health) 1.3. EQ-5D-5L (Quality of life) 1.4. HADS (Anxiety and depression) 1.5. International Physical Activity Questionnaire (IPAQ) 1.6 A service-use questionnaire (SUQ) developed for this study will assess use of NHS or private healthcare, prescription and over-the-counter medicines related to knee pain outside of the study at week 1, week 13, week 26 visits 1.7. Pittsburgh Rehabilitation Participation Scale (PRPS) (week 13 and 26 only) 1.8. Adherence to Exercise Scale for Older Patients (AESOP) (week 13 and 26 only) 2. Clinical and radiological research assessments will include: 2.1. Bilateral tibio-femoral and patellofemoral radiographs (week 1 only) 2.2. Timed Up and Go (TUG) test at week 1, week 13, week 26 visits 2.3. 30-second chair stand test (REF) at week 1, week 13, week 26 visits 2.4. Muscle function testing: isometric strength, isokinetic knee extension, peak power output, fatigue – over 20 knee extensions 2.5. Random cholesterol, HbA1c, and CRP at week 1, week 13, week 26 visits 2.6. Quantitative sensory testing (QST): pain pressure threshold, temporal summation, conditioned pain modulation) at week 1, week 13, week 26 visits 3. Acceptability of the intervention Qualitative interviews will be conducted after the intervention with participants from both intervention arms, representing those with low- and high-adherence to the advice using AESOP. These will explore participants’ overall satisfaction with the intervention and the sequence of treatment, perceptions of nurse-led care and previous treatment experience, level of adherence

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026