Functional motor disorder Nervous System Diseases
Conditions
Interventions
The trialists will perform a randomised controlled trial across several UK hospitals, comparing the specialist physiotherapy programme with standard care. Patients who are diagnosed with FMD by a neur
Sponsors
St George's, University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. New or returning patients presenting to participating outpatient neurology clinics and neurology inpatients 2. The patient has a “clinically definite” diagnosis of FMD according to the Gupta and Lang diagnostic classification criteria (Gupta and Lang 2009)* 3. Aged 18 or over 4. Diagnostic investigations have come to an end 5. The patient is accepting of the intervention 6. Motor symptoms must be sufficient to cause significant distress or impairment in social, occupational or other important areas of functioning (subjectively described by the patient), independent of other comorbidities * Gupta A, Lang AE. Psychogenic movement disorders. Curr Opin Neurol 2009;22:430–6. doi:10.1097/WCO.0b013e32832dc169
Exclusion criteria
Exclusion criteria: 1. The recruiting neurologist deems the patient to have severe psychiatric co-morbidity, including factitious disorder, self-harm, anxiety and depression, which would interfere with the patient’s ability to participate in physiotherapy** 2. The patient has an organic diagnosis which explains the majority of their symptoms or disability 3. pain, fatigue or dissociative seizures that would interfere with their ability to engage in the trial physiotherapy intervention 4. Disability to the extent that the patient requires assistance for toileting 5. The patient is unable to attend 9 sessions of physiotherapy over a 3 week period, within 6 weeks of initial neurology consultation 6. Ongoing unresolved compensation claim or litigation 7. The patient has no fixed address or is seeking rehousing through their council for disability access reasons 8. Unable to understand English sufficiently to complete questionnaires 9. The patient has a documented learning disability that prevents them from answering questionnaires independently 10. The patient lacks capacity to give consent ** The decision to exclude a patient due to psychiatric comorbidity is a clinical decision made by the neurologist, rather than a decision based on a screening tool or questionnaire. We believe that no single screening tool or questionnaire would serve this purpose (due to the range of potential psychiatric problems. Additionally, there is insufficient data on which to base cut-off scores to exclude patients on any particular questionnaire. The recruiting neurologists involved in the trial are consultants in neurology, selected for their experience in managing patients with FMD and patients with psychiatric comorbidity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SF36 Physical Function domain; Timepoint(s): 12 months post randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health related quality of life is assessed using the Short Form 36 v2 at baseline, 6 months and 12 months 2. Mobility is assessed using the Functional Mobility Scale at baseline, 6 months and 12 months 3. Understanding and illness beliefs are assessed using the Revised Illness Perception Questionnaire at baseline, 6 months and 12 months 4. Anxiety and depression are assessed using the Hospital Anxiety & Depression Scale (HADS) at baseline, 6 months and 12 months 5. Fatigue is assessed using a single question rating fatigue on a 5-point scale (from no fatigue to extreme fatigue) at baseline, 6 months and 12 months 6. Employment and return to work is assessed using the Work Productivity & Impairment Questionnaire at baseline, 6 months and 12 months 7. Subjective measures of health service use are assessed using the Client Service Receipt Inventory (CSRI) at baseline, 6 months and 12 months 8. Objective measures of health service use are assessed using Hospital Episode Statistics (HES) and equivalent data from NHS Scotland. Data for the 12 months prior to randomisation will be compared to data for the 12 months post randomisation 9. Quality adjusted life years will be calculated using the EQ-5D-5L Questionnaire, assessed at baseline, 6 months and 12 months 10. Cost-effectiveness of Specialist Physiotherapy compared to treatment as usual will be assessed at 12 months, in a comprehensive health economic analysis, using the CSRI to collect health service use, validated using HES data and the EQ-5D-5L to calculate Quality Adjusted Life Years The following outcome measures were added on 14/09/2018: 11. Participant’s perception of change at 6 and 12 months post randomisation will be assessed using the 5-point Clinical Global Impression Scale of Improvement (CGI-I) 12. The influence of the number of somatic symptoms reported at baseline assessment on treatment outcome at 6 and 12 months post randomisation will be measured by the Extended Patient Health Questionnaire-15 13. | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed