Specialist physiotherapy for functional motor disorder in England and Scotland (Physio4FMD): a pragmatic, multicentre, phase 3 randomised controlled trial.

Background: 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.
Methods: 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.
Findings: 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.
Interpretation: 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.
Funding: National Institute for Health and Care Research and Health Technology Assessment Programme.
Competing Interests: Declaration of interests GN receives research funding from the National Institute for Health and Care Research (NIHR); is a founding member of the Functional Neurological Disorder Society (FNDS); and is on the advisory board for FND patient charities FND Hope UK and FND Action. LM and LHG receive research funding from the NIHR. MJE does medical expert reporting in personal injury and clinical negligence cases, including in cases of functional neurological disorder; has shares in Brain & Mind, which provides neuropsychiatric and neurological rehabilitation in the independent medical sector, including in people with functional neurological disorder; has received financial support for lectures from the International Parkinson's and Movement Disorders Society and the FNDS; receives royalties from Oxford University Press for his book The Oxford Specialist Handbook of Parkinson's Disease and Other Movement Disorder; has received honoraria for medical advice to Teva Pharmaceuticals; receives grant funding, including for studies related to functional neurological disorder, from the National Institute for Health and Care Research and the Medical Research Council; is an associate editor of the European Journal of Neurology; is a member of the international executive committee of the International Parkinson's and Movement Disorders Society and a board member of the FNDS; and is on the medical advisory boards of the charities functional neurological disorder (FND) Hope UK and Dystonia UK. JS reports honoraria from UptoDate, personal fees from Expert Witness Work and grants from National Research Scotland; runs a free self-help website, www.neurosymptoms.org, for patients with Functional Neurological Disorder; and is secretary of FNDS and on the medical advisory boards of the charities FND Hope UK and FND Action. IN has received research funding from NIHR, UK Research and Innovation, and the Wellcome Trust; and was a member of a data safety and monitoring board for a RCT of herbal medication for long COVID. MR has received research funding from Epilepsy Research UK, the NIHR; receives a salary from Elsevier as Editor-in-Chief of Seizure—European Journal of Epilepsy; has received honoraria for talks on unrelated subjects from Angelini Pharma and UCB Pharma; sits on a Lennox Gastaut Syndrome advisory board for UCB Pharma; and received payment from Precisis for chairing a data safety monitoring board of an unrelated commercial study. AC receives research funding from the NIHR, the Medical Research Council, Chief Scientist Office Scotland, and European Union (Etude Program); has received an honorarium from Forum for Indian Neurological Education; personal fees from expert testimony in medicolegal cases relating to FND; is president of the FNDS; and is paid Associate Editor of the Journal of Neurology, Neurosurgery and Psychiatry. All other authors declare no competing interests.
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