Functional motor disorder—the motor variant of functional neurological disorder—is a disabling condition that is commonly associated with poor health outcomes. Pathophysiological models have inspired new treatment approaches such as specialist physiotherapy, although evidence from large randomised controlled trials is absent. We aimed to assess the clinical effectiveness of a specialist physiotherapy intervention for functional motor disorder compared with treatment as usual. In this pragmatic, multicentre, phase 3 randomised controlled trial at 11 hospitals in England and Scotland, adults with a clinically definite diagnosis of functional motor disorder, diagnosed by a neurologist, were included. Participants were randomly assigned (1:1, stratified by site) using a remote web-based application to either specialist physiotherapy (a protocolised intervention of nine sessions plus follow-up) or treatment as usual (referral to local community neurological physiotherapy). Individuals working on data collection and analysis were masked to treatment allocation. The primary outcome was the physical functioning domain of the 36-item short form health questionnaire (SF36) at 12 months after randomisation. The primary analysis followed a modified intention-to-treat principle, using a complete case approach; participants who were unable to receive their randomised treatment due to the suspension of health-care services during the COVID-19 pandemic were excluded from the primary analysis. This trial is registered with the International Standard Randomised Controlled Trial registry, ISRCTN56136713, and is completed. Recruitment occurred between Oct 19, 2018, and March 11, 2020, pausing during the COVID-19 lockdown, and resuming from Aug 3, 2021, to Jan 31, 2022. Of 355 participants who were enrolled, 179 were randomly assigned to specialist physiotherapy and 176 to treatment as usual. 89 participants were excluded from the primary analysis due to COVID-19 interruption to treatment (27 were assigned to specialist physiotherapy and 62 to treatment as usual). After accounting for withdrawals (n=11) and loss to follow-up (n=14), the primary analysis included data from 241 participants (138 [91%] assigned specialist physiotherapy and 103 [90%] assigned treatment as usual). Physical functioning, as assessed by SF36, did not differ significantly between groups (adjusted mean difference 3·5, 95% CI –2·3 to 9·3; p=0·23). There were no serious adverse events related to the trial interventions. 35 serious adverse events were recorded in the specialist physiotherapy group by 24 participants (17·0%), and 24 serious adverse events were recorded in the treatment as usual group by 18 participants (17·0%); one death occurred in the specialist physiotherapy group (cause of death was recorded as suicide). All were considered unrelated to specialist physiotherapy. Although more participants who were assigned specialist physiotherapy self-rated their motor symptoms as improved and had better scores on subjective measures of mental health, the intervention did not result in better self-reported physical functioning at 12 months. Both the specialist and community neurological physiotherapy appeared to be a safe and a valued treatment for selected patients with functional motor disorder. Future research should continue to refine interventions for people with functional motor disorder and develop evidence-based methods to guide treatment triage decisions. National Institute for Health and Care Research and Health Technology Assessment Programme.

中文翻译：

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英格兰和苏格兰功能性运动障碍的专业物理治疗 (Physio4FMD)：一项务实、多中心、3 期随机对照试验


功能性运动障碍（功能性神经障碍的运动变体）是一种致残性疾病，通常与不良健康结果相关。尽管缺乏大型随机对照试验的证据，但病理生理学模型激发了新的治疗方法，例如专业物理治疗。我们的目的是评估功能性运动障碍的专业物理治疗干预与常规治疗相比的临床效果。这项在英格兰和苏格兰 11 家医院进行的务实、多中心、3 期随机对照试验纳入了经神经科医生诊断、临床明确诊断为功能性运动障碍的成年人。使用基于网络的远程应用程序将参与者随机分配（1:1，按地点分层）接受专业物理治疗（九次疗程加随访的协议干预）或照常治疗（转诊至当地社区神经物理治疗）。从事数据收集和分析的个人不知道治疗分配。主要结果是随机分组后 12 个月时 36 项简短健康问卷 (SF36) 的身体机能范围。主要分析遵循修改后的意向治疗原则，使用完整病例方法；因 COVID-19 大流行期间医疗保健服务暂停而无法接受随机治疗的参与者被排除在主要分析之外。该试验已在国际标准随机对照试验登记处注册，ISRCTN56136713，并已完成。招聘于2018年10月19日至2020年3月11日期间进行，在COVID-19封锁期间暂停，并于2021年8月3日至2022年1月31日恢复。 在 355 名参与者中，179 人被随机分配接受专业物理治疗，176 人接受常规治疗。由于 COVID-19 治疗中断，89 名参与者被排除在主要分析之外（27 名参与者被分配接受专科物理治疗，62 名参与者接受照常治疗）。在考虑退出 (n=11) 和失访 (n=14) 后，主要分析包括 241 名参与者的数据（138 [91%] 被指定为专业物理治疗，103 [90%] 被指定为常规治疗）。通过 SF36 评估，各组之间的身体机能没有显着差异（调整后的平均差 3·5，95% CI –2·3 至 9·3；p=0·23）。没有与试验干预措施相关的严重不良事件。专科物理治疗组有24名参与者（17·0%）记录了35起严重不良事件，常规治疗组有18名参与者（17·0%）记录了24起严重不良事件；专科物理治疗组发生 1 例死亡（死因记录为自杀）。所有这些都被认为与专业物理治疗无关。尽管更多接受专业物理治疗的参与者自我评价其运动症状有所改善，并且在心理健康主观测量方面得分更高，但干预措施并未导致 12 个月时自我报告的身体机能有所改善。对于特定的功能性运动障碍患者来说，专家和社区神经物理治疗似乎都是一种安全且有价值的治疗方法。未来的研究应继续完善对功能性运动障碍患者的干预措施，并开发循证方法来指导治疗分诊决策。国家卫生与保健研究所和卫生技术评估计划。