Nielsen G.1,2, Buszewicz M.3, Stevenson F.3, Hunter R.3, Holt K.2, Dudziec M.2, Ricciardi L.1, Marsden J.4, Joyce E.1, Edwards M.5
1University College London, Institute of Neurology, London, United Kingdom, 2National Hospital for Neurology and Neurosurgery, Therapy Services, London, United Kingdom, 3University College London, Primary Care and Population Health, London, United Kingdom, 4University of Plymouth, School of Health Professions, Plymouth, United Kingdom, 5St George's University of London, Institute of Cardiovascular and Cell Sciences, London, United Kingdom
Background: Functional motor symptoms (FMS), also known as conversion disorder, are neurological symptoms that are not caused by known neurological disease. They are amongst the most common diagnoses made in neurology clinics, there are few treatment options and prognosis is poor. Psychological based treatment is traditionally proposed as the treatment of choice, yet evidence for efficacy is limited. Physical based rehabilitation has emerged as a promising treatment with a growing evidence base, however there are no parallel arm randomised controlled trials.
Purpose: The aim was to determine the feasibility of conducting a randomised controlled trial of physiotherapy for FMS. Objectives were to determine acceptability of a specific treatment protocol, to test the utility of a range of outcome measures, and estimate efficacy of the intervention.
Methods: A randomised feasibility study was conducted recruiting patients with a clinically established diagnosis of FMS from a tertiary outpatient neurology clinic in London, UK. Inclusion criteria were age 18 or over; acceptance of the diagnosis and completion of diagnostic investigations. Exclusion criteria were prominent anxiety and depression requiring treatment before starting physiotherapy; FMS not the main problem and level of disability requires assistance for transfers. Participants were randomised to receive the study intervention or treatment as usual control. The intervention was a 5-day physiotherapy delivered treatment programme consisting of education, movement retraining and developing a self management plan. Treatment as usual consisted of a referral to the participant´s local neurophysiotherapy service. The content of physiotherapy recieved by the control group was not standardised. Measures of feasibility and clinical outcome were collected at baseline (prior to randomisation) and six month follow up. Clinical outcome measures included the Short Form 36, 10 metre timed walk, Berg Balance Scale and EQ-5D-5L.
Results: Sixty individuals were recruited over a nine month period and randomised to the control and treatment conditions. There were three withdrawals, leaving 29 intervention and 28 control participants in the final analysis. The intervention was rated as highly acceptable and there were no adverse events. At six months, 72% of the intervention participants rated their symptoms as improved compared to 18% in the control group. There was a moderate to large treatment effect across a range of physical and quality of life outcome measures (Cohens d=0.46-79). EQ-5D-5L utility scores were converted to Quality Adjusted Life Years (QALY). The additional QALYs with intervention was 0.08 (95% CI 0.03, 0.13), the mean incremental cost per QALY gained was £12,087.
Conclusion(s): Feasibility was demonstrated by high rates of recruitment, retention and acceptability of the intervention. The clinical effect size at six months was moderate to large with a high probability of being cost effective. An adequately powered randomised controlled trial is needed.
Implications: This study is the first parallel arm, randomised, controlled study of physiotherapy for FMS. The promising outcome adds to the growing body of evidence that specialist physiotherapy, delivered by experienced clinicians is an effective treatment for FMS. A pragmatically designed, adequately powered, multicentre randomised controlled trial is needed to demonstrate generalisability.
Funding acknowledgements: National Institute for Health Research (NIHR/HEE Clinical Doctoral Research Fellowship, Glenn Nielsen, CDRF-2013-04-034).
Topic: Neurology
Ethics approval: Approval was obtained from the National Research Ethics Service Committee London City Road & Hampstead (14/LO/0572)
All authors, affiliations and abstracts have been published as submitted.
