Harrisson Sarah, Myers Helen, Wynne-Jones Gwenllian, Bajpai Ram, Bratt Claire, Burton Claire, Harrison Rosie, Jowett Sue, Lawton Sarah Ann, Saunders Benjamin, Beard David, Bucknall Milica, Chester Rachel, Heneghan Carl, Huckfield Lucy, Lewis Martyn, Mallen Christian, Pincus Tamar, Rees J L, Roddy Edward, van der Windt Danielle
School of Medicine, Faculty of Medicine & Health Sciences, Keele University, Keele, Staffordshire, UK
Keele Clinical Trials Unit, School of Medicine, Faculty of Medicine & Health Sciences, Keele University, Keele, Staffordshire, UK.
BMJ Open. 2025 May 6;15(5):e100501. doi: 10.1136/bmjopen-2025-100501.
Musculoskeletal shoulder pain is a common reason for people to be treated in physiotherapy services, but diagnosis can be difficult and often does not guide treatment or predict outcome. People with shoulder pain cite a need for clear information, and timely, tailored consultations for their pain. This trial will evaluate the introduction of a personalised guided consultation to help physiotherapists manage care for individuals with shoulder pain.
This is a cluster randomised controlled trial to evaluate the clinical and cost-effectiveness of introducing a personalised guided consultation compared with usual UK NHS physiotherapy care. Physiotherapy services (n=16) will be randomised in a 1:1 ratio to either intervention (physiotherapy training package and personalised guided consultation incorporating a new prognostic tool) or control (usual care); 832 participants (416 in each arm) identified from participating physiotherapy service waiting lists aged 18 years or over with shoulder pain will be enrolled. Follow-up will occur at 3 time points: 6 weeks, 6 months and 12 months. The primary outcome will be the Shoulder Pain and Disability Index (SPADI) score over 12 months. Secondary outcomes include global perceived change of the shoulder condition, sleep, work absence and the impact of shoulder pain on work performance, healthcare utilisation and health-related quality of life (using EuroQol 5 Dimension 5 Level (EQ-5D-5L)). A multimethod process evaluation will investigate views and experiences of participants and physiotherapists, assess uptake, facilitators and barriers to delivery, and changes in factors assumed to explain intervention outcomes. Primary analysis of effectiveness will be by intention-to-treat, and a health economic evaluation will assess cost-utility of introducing the personalised consultation.
The trial received ethics approval from the Yorkshire & The Humber (South Yorkshire) Research Ethics Committee (REC reference: 23/YH/0070). Findings will be shared through journal publications, media outlets and conference presentations. Supported by patient contributors and clinical advisors, we will communicate findings through a designated website, networks, newsletters, leaflets and in the participating physiotherapy services.
ISRCTN45377604.
肌肉骨骼性肩部疼痛是人们接受物理治疗服务的常见原因，但诊断可能很困难，而且通常无法指导治疗或预测结果。肩部疼痛患者表示需要清晰的信息，以及针对其疼痛的及时、个性化咨询。本试验将评估引入个性化指导咨询，以帮助物理治疗师管理肩部疼痛患者的护理情况。
这是一项整群随机对照试验，旨在评估引入个性化指导咨询与英国国民保健制度（NHS）常规物理治疗护理相比的临床效果和成本效益。物理治疗服务机构（n = 16）将按1:1的比例随机分为干预组（物理治疗培训包和包含新预后工具的个性化指导咨询）或对照组（常规护理）；将从参与试验的物理治疗服务机构的候诊名单中招募832名年龄在18岁及以上、患有肩部疼痛的参与者（每组416名）。随访将在3个时间点进行：6周、6个月和12个月。主要结局将是12个月内的肩部疼痛和功能障碍指数（SPADI）评分。次要结局包括对肩部状况的总体感知变化、睡眠、缺勤情况以及肩部疼痛对工作表现、医疗保健利用和健康相关生活质量的影响（使用欧洲五维度五水平健康量表（EQ - 5D - 5L））。一项多方法过程评估将调查参与者和物理治疗师的观点和体验，评估接受情况、实施的促进因素和障碍，以及假定可解释干预结果的因素的变化。有效性的主要分析将采用意向性分析，健康经济评估将评估引入个性化咨询的成本效益。
该试验获得了约克郡和亨伯赛德郡（南约克郡）研究伦理委员会的伦理批准（REC编号：23/YH/0070）。研究结果将通过期刊发表、媒体渠道和会议报告进行分享。在患者贡献者和临床顾问的支持下，我们将通过指定网站、网络、时事通讯、传单以及在参与试验的物理治疗服务机构中传达研究结果。
ISRCTN45377604。
