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

Area of Science:

• Orthopedics
• Primary Care Medicine
• Nursing Practice

Background:

• Osteoarthritis (OA) knee pain is a leading cause of disability.
• Current UK guidelines recommend non-pharmacological treatments (education, exercise, weight loss) as first-line care.
• Suboptimal implementation of these core interventions in primary care necessitates novel delivery approaches.

Purpose of the Study:

• To develop and evaluate a complex, nurse-delivered intervention for osteoarthritis knee pain.
• To assess the feasibility and acceptability of this intervention among patients and nurses.
• To determine the feasibility of conducting a future cohort randomized controlled trial (RCT).

Main Methods:

• Phase 1: Develop nurse training, evaluate non-pharmacological component fidelity and acceptability via checklists and interviews, and modify the intervention.
• Phase 2: Assess feasibility of a cohort RCT comparing three groups: non-pharmacological then pharmacological (A), pharmacological then non-pharmacological (B), and usual care (C).
• Outcomes collected at baseline, 13, and 26 weeks; qualitative interviews conducted.

Main Results:

• The study protocol has been approved and registered (ClinicalTrials.gov NCT03670706).
• Fidelity and acceptability of the non-pharmacological component will be assessed in Phase 1.
• Feasibility of a three-arm cohort RCT will be evaluated in Phase 2.

Conclusions:

• This research protocol outlines a structured approach to developing and testing a nurse-led intervention for osteoarthritis knee pain.
• Findings will inform the design of a definitive RCT, aiming to improve the implementation of evidence-based care for OA.
• The study will provide insights into the practicalities of delivering a complex intervention in primary care settings.