COVID-19 and the Physio4FMD trial: Impact, mitigating strategies and analysis plans, 2023 Marston, Carson, Edwards et al

Abstract
Introduction
Functional motor disorder (FMD) is a common cause of disabling neurological symptoms such as weakness and tremor. Physio4FMD is a pragmatic, multicentre single blind randomised controlled trial to evaluate effectiveness and cost effectiveness of specialist physiotherapy for FMD. Like many other studies this trial was affected by the COVID-19 pandemic.

Methods
The planned statistical and health economics analyses for this trial are described, as well as the sensitivity analyses designed to assess the disruption caused by COVID-19. The trial treatment of at least 89 participants (33%) was disrupted due to the pandemic. To account for this, we have extended the trial to increase the sample size. We have identified four groups based on how participants’ involvement in Physio4FMD was affected; A: 25 were unaffected; B: 134 received their trial treatment before the start of the COVID-19 pandemic and were followed up during the pandemic; C: 89 were recruited in early 2020 and had not received any randomised treatment before clinical services closed because of COVID-19; D: 88 participants were recruited after the trial was restarted in July 2021. The primary analysis will involve groups A, B and D. Regression analysis will be used to assess treatment effectiveness. We will conduct descriptive analyses for each of the groups identified and sensitivity regression analyses with participants from all groups, including group C, separately.

Discussion
The COVID-19 mitigation strategy and analysis plans are designed to maintain the integrity of the trial while providing meaningful results.

https://www.sciencedirect.com/science/article/pii/S2451865423000704?via=ihub

 

Physio4FMD: protocol for a multicentre randomised controlled trial of specialist physiotherapy for functional motor disorder

Abstract
Background
Patients with functional motor disorder (FMD) experience persistent and disabling neurological symptoms such as weakness, tremor, dystonia and disordered gait. Physiotherapy is usually considered an important part of treatment; however, sufficiently-powered controlled studies are lacking. Here we present the protocol of a randomised controlled trial (RCT) that aims to evaluate the clinical and cost effectiveness of a specialist physiotherapy programme for FMD.

Methods/design
The trial is a pragmatic, multicentre, single blind parallel arm randomised controlled trial (RCT). 264 Adults with a clinically definite diagnosis of FMD will be recruited from neurology clinics and randomised to receive either the trial intervention (a specialist physiotherapy protocol) or treatment as usual control (referral to a community physiotherapy service suitable for people with neurological symptoms). Participants will be followed up at 6 and 12 months. The primary outcome is the Physical Function domain of the Short Form 36 questionnaire at 12 months. Secondary domains of measurement will include participant perception of change, mobility, health-related quality of life, health service utilisation, anxiety and depression. Health economic analysis will evaluate the cost impact of trial and control interventions from a health and social care perspective as well as societal perspective.

Discussion
This trial will be the first adequately-powered RCT of physical-based rehabilitation for FMD.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6802344/

 

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.

https://www.isrctn.com/ISRCTN56136713

You can 'enjoy' the study website here, https://www.physio4fmd.org/

 

@Andy did you add this?




[My bolding]

 

No, this is literally there in the plain English summary text.

 

I thought it was too brazen to possibly be included.

 

And yet, this treatment model has been used for years. Decades, if we're splitting hair.

But, sure, trying the same thing again is an idea. An idea about money. Because when you set out to make an economic analysis without even knowing if something works, it's because it's rigged to provide a positive outcome. They even say plainly it's strictly about saving money. While wasting money on quack treatments used for decades that they are testing, yet again.

It's really the broader context that fails everything, that this is endlessly permitted to go on without ever having to deliver anything. There is no professional context where this can work out.

 

I should add I was expressing sarcasm at the fact the intent of these studies is not even being hidden.