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J. Neurol. Neurosurg. Psychiatr. · Jun 2017
Randomized Controlled TrialRandomised feasibility study of physiotherapy for patients with functional motor symptoms.
- G Nielsen, M Buszewicz, F Stevenson, R Hunter, K Holt, M Dudziec, L Ricciardi, J Marsden, E Joyce, and M J Edwards.
- Sobell Department of Motor Neuroscience and Movement Disorders, UCL Institute of Neurology, London, UK.
- J. Neurol. Neurosurg. Psychiatr. 2017 Jun 1; 88 (6): 484-490.
ObjectiveTo determine the feasibility of conducting a randomised controlled trial of a specialist physiotherapy intervention for functional motor symptoms (FMS).MethodsA randomised feasibility study was conducted recruiting patients with a clinically established diagnosis of FMS from a tertiary neurology clinic in London, UK. Participants were randomised to the intervention or a treatment as usual control. Measures of feasibility and clinical outcome were collected and assessed at 6 months.Results60 individuals were recruited over a 9-month period. Three withdrew, leaving 29 intervention and 28 controls participants in the final analysis. 32% of patients with FMS met the inclusion criteria, of which 90% enrolled. Acceptability of the intervention was high and there were no adverse events. At 6 months, 72% of the intervention group rated their symptoms as improved, compared to 18% in the control group. There was a moderate to large treatment effect across a range of outcomes, including three of eight Short Form 36 (SF36) domains (d=0.46-0.79). The SF36 Physical function was found to be a suitable primary outcome measure for a future trial; adjusted mean difference 19.8 (95% CI 10.2 to 29.5). The additional quality adjusted life years (QALY) with intervention was 0.08 (95% CI 0.03 to 0.13), the mean incremental cost per QALY gained was £12 087.ConclusionsThis feasibility study demonstrated high rates of recruitment, retention and acceptability. Clinical effect size was moderate to large with high probability of being cost-effective. A randomised controlled trial is needed.Trial Registration NumberNCT02275000; Results.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
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