Title: The development and feasibility testing of an evidence informed exercise programme for people with chronic non-specific neck pain
Funder: Health Education England

Abstract: Background Neck pain is the third most common cause of disability in the UK with high direct and indirect costs. Economic burden and disability are greatest in those with chronic symptoms (accounting for 75% of people with neck pain). Therefore, as well as delivering short-term relief, interventions need to focus on supporting long-term self-management behaviours to reduce the severity and frequency of any future episodes of disability. Clinical guidelines recommend exercise for chronic non-specific neck pain. However, current exercise strategies have modest short-term effects, low long-term adherence and only 52% make an acceptable recovery. Evidence from other chronic conditions suggests that exercise programmes should consider barriers/facilitators to exercise and integration of behaviour change strategies to enhance adherence and both short and long-term benefits. Currently this is not done for exercise programmes for people with chronic non-specific neck pain. Aim To develop and feasibility-test an evidence informed exercise programme for people experiencing chronic non-specific neck pain. Objectives Work Package (WP) 11. To co-create (with patients and service providers) a chronic non-specific neck pain exercise programme that a) Is easily deliverable by service providers b) Maximises short-term benefits in terms of reduced pain and disability c) Is maximally engaging to patients enabling long-term adherence to exercise and self-management WP22. To inform further refinements to the intervention and the design of a randomised controlled trial (RCT) through the assessment of a) Feasibility and acceptability of the intervention and trial methods to both patients and service providers b) Uptake and retention rates c) Exercise adherence, fidelity and adverse events Methods WP1 - Intervention mapping to co-develop (with patients and service providers) an evidence informed, theory-based exercise programme using clinical guidelines, existing literature (including my own preparatory research), and a series of Patient and Service Provider workshops. WP2 - A multicentre two-arm randomised (2:1) feasibility trial with embedded process evaluation. Sixty-two adults with chronic non-specific neck pain will be randomised to our evidence informed exercise programme (from WP1) or usual practice exercise. The main outcomes (uptake rate, retention rate, intervention acceptability, adherence, intervention fidelity and adverse events) will be compared with a priori criteria for progression to a clinical trial. We will collect patient outcome data at 3- and 6-months including Neck Disability Index and other patient reported outcome measures. Trial procedures and exercise acceptability, adherence and safety will be further evaluated using one-to-one interviews with 15-20 participants and 6-8 treatment-providing physiotherapists.Timelines WP1: August 2022-h;July 2023 WP2: August 2023-Febuary 2025 Thesis Writing /Dissemination: August 2024-August 2025 Anticipated impact1. Development of a co-produced, evidence informed exercise programme for people with chronic non-specific neck pain 2. Subject to feasibility, a post-doctoral Fellowship application for a clinical trial evaluating the long-term clinical and cost effectiveness of the developed exercise programme compared to usual practice. Dissemination (informed by PPI and key stakeholders)1. Publication of the exercise programme development process and feasibility study results2. International and national conference presentations3. Intervention training package4. Lay summary for public audiences

Lay abstract: Background Neck pain is the 3rd leading cause of disability in the United Kingdom. Pain, disability, impact on work and healthcare costs are greatest in those with recurring or long-term symptoms without a specific underlying cause. This type of neck pain is described as chronic non-specific neck pain. Treatment guidelines recommend physiotherapy led exercise for people with chronic non-specific neck pain. Even though physiotherapists follow treatment guidelines, current exercise programmes are inadequate. Research shows people with chronic non-specific neck pain do not adhere to current exercise programmes with 48% having insufficient long-term recovery. As such people with chronic non-specific neck pain continue to experience frequent episodes of pain and disability for many years which has a significant impact on their lives. Research from other chronic conditions shows that exercise programmes can be improved to increase adherence and enable long-term self-management of symptoms. This is done by prescribing exercise with an understanding of factors that make exercise harder or easier to complete (exercise barriers and facilitators) and using specific strategies to help people change their behaviours to perform exercises. Currently this is not done for neck pain. Aims1. To develop an exercise programme for chronic non-specific neck pain that results in high levels of adherence and enables long-term self-management2. To assess acceptability of the developed exercise programme and whether it is possible to conduct a large and expensive long-term clinical trial testing the effectiveness of the developed exercise programme compared to current neck pain exercise programmes Research Plan The research project will consist of two linked studies. Study 1: An exercise programme will be created using a combination of patient and physiotherapist workshops, existing research, clinical guidelines, and theories about how people are helped to change behaviours. Study 2: To determine whether a large, long-term clinical trial is possible, a smaller feasibility trial will be conducted at two NHS Trusts. Sixty-two participants with chronic non-specific neck pain will be randomly allocated to one of two different physiotherapy interventions. One will be the exercise programme that is usually delivered in the NHS. The second will be the exercise programme developed in Study 1. The research will measure recruitment and dropout rates. A sample of treatment sessions will be audio recorded to check the exercise programmes are delivered as intended. Electronic and postal questionnaires at 3 and 6 months will measure exercise safety, adherence, and acceptability. Up to 20 participants and 8 physiotherapists will also be interviewed to better understand exercise safety, adherence, and acceptability and to comprehend their experience in taking part in the study. Patient and Public Involvement Seven people with chronic non-specific neck pain and 1 member of the public have already commented on the importance of this research and contributed to the study design, clinical academic training plan and this plain English summary. People with neck pain and members of the public will co-design the exercise programme (Study 1) and will also sit on the steering group, monitoring research conduct, analysis and sharing of results. Sharing of Results The results will be used to improve exercise programmes for people with chronic non-specific neck pain and to plan a larger clinical trial. The findings will be shared in academic journals, conferences and through online training programmes. Public friendly leaflets and videos will also be shared. Providing the results demonstrate a larger clinical trial is possible and worthwhile, a major output will be a grant application for a long-term clinical trial to determine whether the exercise programme developed from this research is clinically and cost effective compared to current NHS exercise programmes.

Research activity codes: 6.7 PHYSICAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: DISPUTED AETIOLOGY AND OTHER