Trial Report Specialist physiotherapy for functional motor disorder in England and Scotland (Physio4FMD):... 2024 Nielsen, Stone, Carson, Edwards et al

One trial has resulted in three papers. As well as this main paper, there is:

Which factors predict outcome from specialist physiotherapy for functional motor disorder?... 2025, Nielsen, Stone, Carson, Edwards et al

Cost Utility of Specialist Physiotherapy for Functional Motor Disorder (Physio4FMD), 2025, Hunter, Stone, Carson, Edwards et al

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Full title: Specialist physiotherapy for functional motor disorder in England and Scotland (Physio4FMD): a pragmatic, multicentre, phase 3 randomised controlled trial

Summary

Background
Functional motor disorder—the motor variant of functional neurological disorder—is a disabling condition that is commonly associated with poor health outcomes. Pathophysiological models have inspired new treatment approaches such as specialist physiotherapy, although evidence from large randomised controlled trials is absent. We aimed to assess the clinical effectiveness of a specialist physiotherapy intervention for functional motor disorder compared with treatment as usual.

Methods
In this pragmatic, multicentre, phase 3 randomised controlled trial at 11 hospitals in England and Scotland, adults with a clinically definite diagnosis of functional motor disorder, diagnosed by a neurologist, were included. Participants were randomly assigned (1:1, stratified by site) using a remote web-based application to either specialist physiotherapy (a protocolised intervention of nine sessions plus follow-up) or treatment as usual (referral to local community neurological physiotherapy). Individuals working on data collection and analysis were masked to treatment allocation. The primary outcome was the physical functioning domain of the 36-item short form health questionnaire (SF36) at 12 months after randomisation. The primary analysis followed a modified intention-to-treat principle, using a complete case approach; participants who were unable to receive their randomised treatment due to the suspension of health-care services during the COVID-19 pandemic were excluded from the primary analysis. This trial is registered with the International Standard Randomised Controlled Trial registry, ISRCTN56136713, and is completed.

Findings
Recruitment occurred between Oct 19, 2018, and March 11, 2020, pausing during the COVID-19 lockdown, and resuming from Aug 3, 2021, to Jan 31, 2022. Of 355 participants who were enrolled, 179 were randomly assigned to specialist physiotherapy and 176 to treatment as usual. 89 participants were excluded from the primary analysis due to COVID-19 interruption to treatment (27 were assigned to specialist physiotherapy and 62 to treatment as usual). After accounting for withdrawals (n=11) and loss to follow-up (n=14), the primary analysis included data from 241 participants (138 [91%] assigned specialist physiotherapy and 103 [90%] assigned treatment as usual). Physical functioning, as assessed by SF36, did not differ significantly between groups (adjusted mean difference 3·5, 95% CI –2·3 to 9·3; p=0·23). There were no serious adverse events related to the trial interventions. 35 serious adverse events were recorded in the specialist physiotherapy group by 24 participants (17·0%), and 24 serious adverse events were recorded in the treatment as usual group by 18 participants (17·0%); one death occurred in the specialist physiotherapy group (cause of death was recorded as suicide). All were considered unrelated to specialist physiotherapy.

Interpretation
Although more participants who were assigned specialist physiotherapy self-rated their motor symptoms as improved and had better scores on subjective measures of mental health, the intervention did not result in better self-reported physical functioning at 12 months. Both the specialist and community neurological physiotherapy appeared to be a safe and a valued treatment for selected patients with functional motor disorder. Future research should continue to refine interventions for people with functional motor disorder and develop evidence-based methods to guide treatment triage decisions.

Open access, https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(24)00135-2/

 

They clearly didn't work hard enough on their placebo effect.

 

Just looked up who carried out the trial FMD | Physio4fmd

Safe?!

The following are some references from the Timeline I've been creating.

 

0 = 0 = effective = give us more money.

The scam equation.

Imagine being in any other job and doing a lot of work, to then show your boss that you did no better than something that you were already doing and lacks evidence of efficacy and concluding that they should spend resources on both and give you more money to try the same thing again. Do you get laughed at before you get fired? Or do you get fired and then they laugh at you once you leave the room?

Not here. Here they will give more money for this, after having already given you money for the same thing before. Two of the biggest names in the field, so this is the "best of the best" that they can do. And they best they can do is... nothing is no worse than nothing.

I follow a lot of politics. It fascinates me. There is so much bullshit in politics. Exactly as much as in psychosomatic ideology. It's completely absurd. Almost everything plays out the same way.

 

So it didn’t do anything for physical function- even when using self report and probably all sorts of special wrapping (about how this will have positive effect, think positive etc)

 

In the CODES trial for "functional seizures," they had null results for their primary outcome of seizure reduction. They claimed success anyway on the basis of some vague secondary outcomes and said seizure reduction was not the right primary outcome anyway, even though they had promoted that as the appropriate primary outcome for ten years.

Maybe in this case they can also try to argue that the improved motor function isn't the best outcome and all that matters are "quality of life" measures.

 

https://virology.ws/2025/04/21/tria...iotherapy-in-functional-motor-disorder-trial/

 

Good catch, @Hutan !

I also found this in the supplementary file:

There are two things to take away from this criteria:
First, the authors do not consider FMD to be an «organic» diagnosis. Which implies they have a dualist view of mind and body.

Second, the FMD diagnosis is contingent on whether or not the diagnosing neurologist believe that the symptoms can be adequately explained by the observed organic deviations (if there are any).

I wonder how the second point fits with e.g. migraines that often to not show up in imaging?

 

I came here to say just this.

 

And only emphasizes how despite any bleating and whining, the entire concept is based on lack of evidence that it's something they understand. It's that drawer in the kitchen where anything that doesn't have a place gets dumped into a pile of mess.

But really the problem is not with the ideologues, it's with a profession that accepts this nonsense. They have nothing. All their trials have failed for decades. They slightly changed their stories, but they haven't actually found anything new since. Nothing at all. And it's expanding fast everywhere. The future of medicine is considered "biopsychosocial", even though it has achieved absolutely nothing. Total reverse meritocracy.


This is evidence-based medicine in a nutshell: evidence is irrelevant, and the only thing that matters is that they don't feel that it's medical so whatever mediocre pseudoscience someone wants to throw at it is fine, no one actually cares. They keep noting how the costs keep rising, even as this ideology becomes more influential, and no one cares, there is zero interest in actually solving this or helping those affected by it. This is not how to help people. It's explicitly how not to help anyone but themselves.

 

I think you're giving them too much credit. I doubt they have even. heard of Physios4ME--I think they exist in a somewhat insular world. What would be the advantage to deliberately having a similar name?

 

Seems like pretty much all the secondary outcomes had null effects as well.

• SF36 physical functioning (primary outcome)
• SF36 physical role limitations
• SF36 bodily pain
• SF36 general health perceptions
• SF36 energy and vitality
• SF36 social functioning
• SF36 emotional role limitations
• SF36 mental health
• Functional mobility scale
• Hospital Anxiety and Depression Scale— anxiety
• Hospital Anxiety and Depression Scale— depression
• Fatigue

For SF36 mental health there was an effect but it probably wasn't clinically significant. So the only exception that had better results for the intervention group was the CGI-I. It works like this:

I suspect this scale is more susceptible to response bias and placebo effects because it has no external reference like the SF-36 has. It does not ask about a specific symptom or activity that the participant has to think about, it basically just asks: 'did you improve or not?'

In addition, it dichotomises 5 possible responses into 2. Hard to see why researchers would think that this is the best outcome for a randomized trial.

I also note that that they did not correct for multiple comparisons. Not sure if the CGI-I p-value would still be significant, given that they tested more than 10 outcomes at 6 and 12 months.