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., Greenhaff, P., Das Nair, R., Doherty, M., Walsh, D. 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