BACKGROUND Musculoskeletal (MSK) pain from the five most common presentations to primary care (back, neck, shoulder, knee or multi-site pain), where the majority of patients are managed, is a costly global health challenge. At present, first-line decision-making is based on clinical reasoning and stratified models of care have only been tested in patients with low back pain. We therefore, examined the feasibility of; a) a future definitive cluster randomised controlled trial (RCT), and b) General Practitioners (GPs) providing stratified care at the point-of-consultation for these five most common MSK pain presentations. METHODS The design was a pragmatic pilot, two parallel-arm (stratified versus non-stratified care), cluster RCT and the setting was 8 UK GP practices (4 intervention, 4 control) with randomisation (stratified by practice size) and blinding of trial statistician and outcome data-collectors. Participants were adult consulters with MSK pain without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records were tagged and individuals sent postal invitations using a GP point-of-consultation electronic medical record (EMR) template. The intervention was supported by the EMR template housing the Keele STarT MSK Tool (to stratify into low, medium and high-risk prognostic subgroups of persistent pain and disability) and recommended matched treatment options. Feasibility outcomes included exploration of recruitment and follow-up rates, selection bias, and GP intervention fidelity. To capture recommended outcomes including pain and function, participants completed an initial questionnaire, brief monthly questionnaire (postal or SMS), and 6-month follow-up questionnaire. An anonymised EMR audit described GP decision-making. RESULTS GPs screened 3063 patients (intervention = 1591, control = 1472), completed the EMR template with 1237 eligible patients (intervention = 513, control = 724) and 524 participants (42%) consented to data collection (intervention = 231, control = 293). Recruitment took 28 weeks (target 12 weeks) with > 90% follow-up retention (target > 75%). We detected no selection bias of concern and no harms identified. GP stratification tool fidelity failed to achieve a-priori success criteria, whilst fidelity to the matched treatments achieved "complete success". CONCLUSIONS A future definitive cluster RCT of stratified care for MSK pain is feasible and is underway, following key amendments including a clinician-completed version of the stratification tool and refinements to recommended matched treatments. TRIAL REGISTRATION Name of the registry: ISRCTN. TRIAL REGISTRATION NUMBER 15366334. Date of registration: 06/04/2016.

中文翻译：

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肌肉骨骼疼痛的分层初级护理与非分层护理：STarT MSK 可行性和试点集群随机对照试验的结果。

背景肌肉骨骼（MSK）疼痛是初级保健中最常见的五种症状（背部、颈部、肩部、膝盖或多部位疼痛），大多数患者都在初级保健中得到管理，这是一项代价高昂的全球健康挑战。目前，一线决策基于临床推理，分层护理模式仅在腰痛患者中进行了测试。因此，我们研究了可行性；a) 未来明确的整群随机对照试验 (RCT)，以及 b) 全科医生 (GP) 在咨询点针对这五种最常见的 MSK 疼痛表现提供分层护理。方法 该设计是一项务实的试点、两个平行组（分层与非分层护理）、整群随机对照试验，设置为 8 个英国全科医生诊所（4 个干预，4 个对照），随机化（按诊所规模分层）和盲法试验统计学家和结果数据收集者。参与者是患有 MSK 斯隆疼痛的成年咨询者，没有严重病理、紧急医疗需求或脆弱性的迹象。潜在的参与者记录被标记，个人使用全科医生咨询点电子病历 (EMR) 模板发送邮寄邀请。该干预措施得到了包含 Keele STarT MSK 工具（将持续性疼痛和残疾分为低、中和高风险预后亚组）的 EMR 模板和推荐的匹配治疗方案的支持。可行性结果包括对招募和随访率、选择偏倚和全科医生干预保真度的探索。为了获取包括疼痛和功能在内的建议结果，参与者完成了初始调查问卷、简短的每月调查问卷（邮寄或短信）以及 6 个月的随访调查问卷。匿名 EMR 审计描述了 GP 的决策。结果 全科医生筛查了 3063 名患者（干预 = 1591 名，对​​照 = 1472 名），完成了 1237 名符合条件的患者（干预 = 513 名，对照 = 724 名）的 EMR 模板，524 名参与者 (42%) 同意收集数据（干预 = 231 名，对​​照 = 293）。招募耗时 28 周（目标 12 周），后续保留率 > 90%（目标 > 75%）。我们没有发现任何值得关注的选择偏差，也没有发现任何危害。GP 分层工具的保真度未能达到先验的成功标准，而对匹配治疗的保真度则实现了“完全成功”。结论 未来针对 MSK 疼痛的分层护理的最终集群随机对照试验是可行的，并且正在进行中，主要修改包括临床医生完成的分层工具版本和对推荐的匹配治疗的改进。试用注册 注册机构名称：ISRCTN。试用注册号 15366334。注册日期：2016 年 6 月 4 日。