Knee Pain Nurse Led Package of CareTrial

NCT03670706 | Completed

• 1 other identifier: Team-KP
• Study Type: interventional
• Target: 1,806
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To evaluate fidelity of delivery of individual components of this complex package of care for knee pain
3. 3.To assess the acceptability of the intervention by exploring participant satisfaction with nurse-led complex package of care of knee pain.
4. 4.To explore and resolve possible challenges to delivery of individual components within a complex package
5. 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. 6.To explore whether such a trial should provide analgesia before non-pharmacologic interventions or vice versa

Conditions

Osteoarthritis, Knee; Pain, Joint

Outcome Measures

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

  26 weeks

Study Arms (3)

Group A

ACTIVE COMPARATOR

Exercise training, then crossover to analgesic optimisation

Behavioral: Exercise; Other: analgesic optimisation

Group B

ACTIVE COMPARATOR

Analgesic optimisation, then crossover to exercise training

Behavioral: Exercise; Other: analgesic optimisation

Group C

NO INTERVENTION

Control group

Interventions

Exercise BEHAVIORAL

Package of care

Also known as: Package of care

Group A; Group B

analgesic optimisation OTHER

optimisation

Group A; Group B

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 37610332 DERIVED

• 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.

  PMID: 34326044 DERIVED

• 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.

  PMID: 32912951 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthralgia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Abhishek Abhishek

  University of Nottingham/ Nottingham University NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 13, 2018
• Study Start: November 26, 2018
• Primary Completion: July 5, 2021
• Study Completion: July 5, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

GB (1)