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.

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
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.

Trial registrations: ISRCTN81746901.

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慢性非特异性颈部疼痛患者的共同设计颈部运动(EPIC-Neck)与常规运动护理:随机可行性研究方案及过程评估
背景:临床指南推荐慢性非特异性颈部疼痛患者通过物理治疗引导的运动自我管理症状。然而,目前的锻炼策略只有适度的短期效果,参与度很差,48%的人继续经历长期和复发性疼痛。需要使用复杂的干预发展框架共同制定更新的运动策略,考虑运动处方的行为、心理、环境和技术方面,以及患者的依从性,以优化症状结果、长期参与和自我管理。本研究测试了EPIC-Neck项目(“通过共同设计改善运动处方”)的可行性和可接受性,该项目基于证据和理论,并使用干预制图原则共同制作。EPIC-Neck项目的目的是优化颈部运动的短期结果和长期参与。方法:这是一项随机可行性研究,通过过程评估来评估EPIC-Neck项目的可行性和可接受性,并为设计一项评估EPIC-Neck项目临床和成本效益的大规模决定性试验提供信息。一项多中心双臂随机对照可行性研究,旨在招募45名患有慢性非特异性颈部疼痛的成年人,将在英国NHS肌肉骨骼物理治疗部门进行。招聘将从等候名单和诊所广告中进行。参与者将按2:1的比例随机分配到EPIC-Neck项目(n = 30)或常规运动护理(n = 15)。主要可行性目标是通过评估交付保真度、可接受性、污染、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的决定性试验。其他可行性目标是评估安全性,定义常规运动护理,完善EPIC-Neck项目和训练,并探索参加和未参加研究的人群的人口统计数据。结果将通过基线、随机化后3个月和6个月的问卷调查、预约录音、接受EPIC-Neck项目的参与者(n = 12-15)和物理治疗师一对一的半结构化访谈来评估。讨论:这项可行性研究将为EPIC-Neck项目的可行性和可接受性提供证据,并指导开展一项明确的随机对照试验,评估其在NHS中的临床和成本效益。试验注册号:ISRCTN81746901。
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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
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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