Price Jonathan, Rushton Alison, Ives Natalie, Jolly Kate, Parmar Priti, Greaves Colin
Musculoskeletal Physiotherapy Services, Birmingham Community Healthcare NHS Foundation Trust, Birmingham, UK.
School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.
Pilot Feasibility Stud. 2025 Mar 8;11(1):26. doi: 10.1186/s40814-025-01608-6.
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.
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.
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.
ISRCTN81746901.
临床指南建议慢性非特异性颈部疼痛患者通过以物理治疗为主导的锻炼进行症状自我管理。然而，目前的锻炼策略短期效果有限，参与度低，且48%的患者仍持续经历长期和复发性疼痛。需要采用复杂干预开发框架共同制定更新的锻炼策略，该策略应考虑锻炼处方的行为、心理、环境和技术方面以及患者的依从性，以优化症状改善效果、长期参与度和自我管理能力。本研究测试了基于证据和理论并采用干预映射原则共同制定的EPIC-Neck计划（“通过共同设计改进运动处方”）的可行性和可接受性。EPIC-Neck计划的目的是优化颈部锻炼的短期效果和长期参与度。
这是一项带有过程评估的随机可行性研究，旨在评估EPIC-Neck计划的可行性和可接受性，并为评估EPIC-Neck计划临床和成本效益的大规模确定性试验的设计提供信息。一项多中心双臂随机对照可行性研究将在英国国民健康服务体系（NHS）的肌肉骨骼物理治疗科室开展，目标是招募45名患有慢性非特异性颈部疼痛的成年人。招募将通过等候名单和诊所广告进行。参与者将以2:1的比例被随机分配到EPIC-Neck计划组（n = 30）或常规锻炼护理组（n = 15）。主要可行性目标是通过评估实施保真度、可接受性、污染情况以及招募和保留率（随访时的结果完成情况）来确定是否继续进行大规模确定性试验。其他可行性目标包括评估安全性、定义常规锻炼护理、完善EPIC-Neck计划及其培训，并探索参与和未参与该研究的人群的人口统计学特征。结果将通过基线时、随机分组后3个月和6个月的问卷、预约音频记录以及对接受EPIC-Neck计划的参与者（n = 12 - 15）和物理治疗师进行的一对一半结构化访谈来评估。
这项可行性研究将提供EPIC-Neck计划可行性和可接受性的证据，并指导开展一项确定性随机对照试验，以评估其在NHS内的临床和成本效益。
ISRCTN81746901。
