Condition category
Nervous System Diseases
Date applied
26/03/2018
Date assigned
27/03/2018
Last edited
14/09/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Functional motor disorder (FMD), also known as conversion disorder, is a common disorder affecting movement. Symptoms include weakness, tremor, spasms and difficulty walking. The problem is part of the spectrum of neurological symptoms that are not caused by a recognisable disease process and relates to a disturbance in motor (movement) control and sensory perception. People with FMD suffer disability and distress equivalent to people with neurodegenerative disease such as Parkinson’s disease. The prognosis of FMD is considered poor and current treatment options are limited. Physiotherapy is widely considered an important part of treatment, but there is limited evidence to supports its use. A specialised physiotherapy treatment programme has been developed for people with FMD which showed promising results in a number of small studies. This study will test whether the specialist physiotherapy programme is better than standard care at reducing disability caused by FMD and whether the treatment could save the NHS money.

Who can participate?
Patients aged 18 and over with FMD

What does the study involve?
Participants are randomly allocated to receive either the specialised physiotherapy programme or standard care. The specialist physiotherapy consists of nine sessions completed over 3 weeks and a follow-up session. The treatment includes education about FMD, learning ways to control movement, and developing a long-term plan to help symptoms improve. Standard care involves a referral to local community physiotherapy for strength, balance and walking exercises. Participants are followed up after 6 and 12 months by completing 11 questionnaires either by post, telephone, or an online form using a secure internet application. The number of hospital contacts is also recorded for participants in each group.

What are the possible benefits and risks of participating?
The main benefit of taking part in the study is that participants receive a care plan that conforms to best practice recommendations. This includes a comprehensive explanation of the diagnosis of FMD by their neurologist. This is widely considered the first important step in treatment. The care plan also includes a referral to physiotherapy that states the diagnosis of FMD. Physiotherapists often report that patients with FMD are referred to their service without being told their diagnosis. The participant will be followed up by their neurologist. The physical risks associated with the physiotherapy are minimal. The physical treatment strategies involve practicing normal movements such as standing up, sitting down, stepping, walking and going up and down stairs. Exercises are usually performed at a low intensity. Falling is a potential risk in people with reduced balance. However, physiotherapists are experienced at assessing falls risks and preventing falls, as this forms part of normal physiotherapy practice. Chronic pain and fatigue are common in people with FMD. Participation in physiotherapy can potentially exacerbate chronic pain and fatigue. This however would be transient. There is a small risk that participating in the intervention may cause psychological distress. While patients with FMD often have higher rates of anxiety and depression, psychiatric illness and a past history of psychological trauma are not as common in patients with FMD as once thought.

Where is the study run from?
1. St George’s University Hospital (UK)
2. Western General Hospital (UK)

When is the study starting and how long is it expected to run for?
May 2018 to November 2021

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Glenn Nielsen

Trial website

Contact information

Type

Scientific

Primary contact

Dr Glenn Nielsen

ORCID ID

http://orcid.org/0000-0001-6053-5670

Contact details

St George’s
University of London
Neurosciences Research Centre
Molecular & Clinical Sciences Research Institute
Cranmer Terrace
London
SW17 0RE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36950

Study information

Scientific title

A randomised controlled trial of specialist Physiotherapy for Functional Motor Disorder (Physio4FMD)

Acronym

Physio4FMD

Study hypothesis

Functional motor disorder (FMD), also known as conversion disorder, is a common disorder affecting movement. Patients typically present with weakness, tremor, spasms and difficulty walking. The problem is part of the spectrum of neurological symptoms that are not caused by a recognisable disease process and relates to a disturbance in motor control and sensory perception. People with FMD suffer disability and distress equivalent to people with neurodegenerative disease such as Parkinson’s disease. The prognosis of FMD is considered poor and current treatment options are limited. Physiotherapy is widely considered an important part of treatment, however there is limited evidence to supports its use.

The trialists have developed a specialised physiotherapy treatment programme for people with FMD which showed promising results in a number of small studies. This trial will test whether the specialist physiotherapy programme is better than standard care at reducing disability caused by FMD and whether the treatment could save the NHS money.

Ethics approval

London – Surrey Borders Research Ethics Committee, 21/03/2018, ref: 18/LO/0486

Study design

Randomised; Interventional; Design type: Treatment, Education or Self-Management, Physical, Rehabilitation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Neurological disorders, Primary sub-specialty: Other; UKCRC code/ Disease: Neurological/ Other disorders of the nervous system

Intervention

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 neurologist will be invited to take part. Those who consent will be randomised to receive either our specialised physiotherapy programme or standard care. The specialist physiotherapy consists of 9 sessions completed over 3 weeks and a follow up session. The treatment includes education about FMD, learning ways to control movement, and developing a long-term plan to help symptoms improve. Standard care involves a referral to local community physiotherapy for strength, balance and walking exercises. Participants will be followed up at 6 and 12 months after enrolment by completing 9 questionnaires sent by post or over the telephone. We will also compare the number of hospital contacts recorded by the NHS for participants in each group.

Intervention type

Other

Phase

Drug names

Primary outcome measure

SF36 Physical Function domain; Timepoint(s): 12 months post randomisation

Secondary outcome measures

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. The impact of specialist physiotherapy compared to treatment as usual on the participant’s confidence that their diagnosis of FMD is correct at 6 and 12 months post randomisation, using a 10 point scale

Overall trial start date

01/05/2018

Overall trial end date

30/11/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 264; UK Sample Size: 264

Participant 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.

Recruitment start date

01/09/2018

Recruitment end date

30/04/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St George’s University Hospital
Department of Neurology Atkinson Morley Wing Blackshaw Road
London
SW17 0QT
United Kingdom

Trial participating centre

Western General Hospital
Department of Clinical Neurosciences
Edinburgh
EH4 2XU
United Kingdom

Sponsor information

Organisation

St George's, University of London

Sponsor details

c/o Miss Motunrayo A Taiwo
Research Governance and Facilitation Officer
Joint Research and Enterprise Office
London
-
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/31/63

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists intend to publish the trial protocol by 01/05/2019. The protocol will soon be available on the NIHR Portfolio website: https://www.journalslibrary.nihr.ac.uk/programmes/hta/163163/#/. The trialists intend to publish the main trial findings in a high-impact peer reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/11/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/09/2018: The following changes were made to the trial record: 1. The interventions were changed from "Participants will be followed up at 6 and 12 months after enrolment by completing 9 questionnaires sent by post or over the telephone." to "Participants will be followed up at 6 and 12 months after enrolment by completing 11 questionnaires either by post, telephone, or an online form using a secure internet application (depending on the participant’s preference)." 2. Secondary outcome measures 11, 12 and 13 have been added. 3. The following changes have been made to the participant exclusion criteria: 3.1. Exclusion criterion 3 has been changed from "Pain, fatigue or dissociative seizures are the most disabling symptom" to "Pain, fatigue or dissociative seizures that would interfere with their ability to engage in the trial physiotherapy intervention" 3.2. Exclusion criterion 9 has been changed from "diagnosed" to "diagnosed" 4. The "what does the study involve?" section of the plain English summary was changed from "Participants are followed up after 6 and 12 months by completing nine questionnaires sent by post or over the telephone." to "Participants are followed up after 6 and 12 months by completing 11 questionnaires either by post, telephone, or an online form using a secure internet application"