The East Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility study protocol

Hall, Michelle C; Fuller, Amy; Nomikos, Polykarpos Angelos; Millar, Bonnie; Ogollah, Reuben; Valdes, Ana; Greenhaff, Paul; Das Nair, Roshan; Doherty, Michael; Walsh, David A; Abhishek, Abhishek

Abstract

Introduction: Knee pain and osteoarthritis (OA) are a common cause of disability. The UK National Institute of Health and Care Excellence (NICE) OA guidelines recommend education, exercise and weight-loss advice (if overweight) as core interventions before pharmacological adjuncts. However, implementation of these in primary care is often suboptimal. This study aims to develop a complex intervention with non-pharmacological and pharmacological components that can be delivered by nurses. The feasibility and acceptability of the intervention, and feasibility of undertaking a future cohort-randomised controlled trial (RCT) will be explored.

Methods and analysis: In phase 1, we will develop a training programme for nurses and evaluate the fidelity and acceptability of the non-pharmacological element of the intervention. Fidelity checklists completed by the nurse will be compared to video-analysis of the treatment sessions. Patients and nurses will be interviewed to determine the acceptability of the intervention and explore challenges to intervention delivery. The non-pharmacological component will be modified based upon the findings. In phase 2, we will assess the feasibility of conducting a cohort RCT comprising of both the pharmacological and modified non-pharmacological components. We will compare three groups: group A will receive the non-pharmacological components delivered before pharmacological components; group B will receive pharmacological components followed by the non-pharmacological components; and group C (control arm) will continue to receive usual care. Study outcomes will be collected at 3 time points: baseline and weeks 13 and 26 after randomisation. Qualitative interviews will be conducted with a sample of participants from each of the two active intervention arms.

Ethics and dissemination: This protocol was approved by the East Midlands-Derby Research Ethics Committee (18/EM/0288) and registered at clinicaltrials.gov (NCT03670706). The study will be reported in accordance with the CONSORT guidance and standards. The results will be submitted for publication in peer-reviewed academic journals.

Citation

Hall, M. C., Fuller, A., Nomikos, P. A., Millar, B., Ogollah, R., Valdes, A., …Abhishek, A. (2020). The East Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility study protocol. BMJ Open, 10(9), Article e037760

• Journal Article Type: Article
• Acceptance Date: Jul 22, 2020
• Online Publication Date: Sep 9, 2020
• Publication Date: Sep 9, 2020
• Deposit Date: Sep 9, 2020
• Publicly Available Date: Sep 9, 2020
• Journal: BMJ Open
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 10
• Issue: 9
• Article Number: e037760
• Keywords: Feasibility, Complex intervention, Knee pain, Osteoarthritis, Nurse-led care, exercise, Weight-loss, Education, Analgesia
• Public URL: https://nottingham-repository.worktribe.com/output/4889803
• Publisher URL: https://bmjopen.bmj.com/content/10/9/e037760