Co-designed neck exercise (EPIC-Neck) vs usual exercise care for people with chronic non-specific neck pain: protocol for a randomised feasibility study with process evaluation.
Jonathan Price, Alison Rushton, Natalie Ives, Kate Jolly, Priti Parmar, Colin Greaves
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引用次数: 0
Abstract
Background: Clinical guidelines recommend that people with chronic non-specific neck pain self-manage symptoms with physiotherapy-led exercise. However, current exercise strategies have modest short-term effects, engagement is poor, and 48% of people continue to experience long-term and recurrent pain. Updated exercise strategies co-produced using complex intervention development frameworks are required that consider the behavioural, psychological, environmental, and technical aspects of exercise prescription and patient adherence to optimise symptom outcomes, long-term engagement, and self-management. This study tests the feasibility and acceptability of the EPIC-Neck programme ("Exercise Prescription Improved through Co-design") which is grounded in evidence and theory and was co-produced using intervention mapping principles. The aim of the EPIC-Neck programme is to optimise the short-term outcomes of and long-term engagement with neck exercise.
Methods: This is a randomised feasibility study with process evaluation to assess the feasibility and acceptability of the EPIC-Neck programme and inform the design of a large-scale definitive trial evaluating the clinical and cost-effectiveness of the EPIC-Neck programme. A multicentre two-arm randomised controlled feasibility study aiming to recruit 45 adults with chronic non-specific neck pain will be conducted in UK NHS musculoskeletal physiotherapy departments. Recruitment will be from waiting lists and clinic advertisements. Participants will be individually randomised in 2:1 ratio to either the EPIC-Neck programme (n = 30) or usual exercise care (n = 15). The primary feasibility objective is to determine whether to continue to a large-scale definitive trial by evaluating delivery fidelity, acceptability, contamination, and rates of recruitment and retention (outcome completion at follow-up). Other feasibility objectives are to evaluate safety, define usual exercise care, refine the EPIC-Neck programme and training, and explore the demographics of people who do and do not enrol onto the study. Outcomes will be assessed by questionnaires at baseline and at 3- and 6-month post-randomisation, appointment audio-recordings, and one-to-one semi-structured interviews with participants receiving the EPIC-Neck programme (n = 12-15) and physiotherapists.
Discussion: This feasibility study will provide evidence of the feasibility and acceptability of the EPIC-Neck programme and guide the development of a definitive randomised controlled trial evaluating its clinical and cost-effectiveness within the NHS.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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