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

Discussion in 'Other psychosomatic news and research' started by Andy, May 22, 2024.

  1. Andy

    Andy Retired committee member

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    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/
     
    Last edited by a moderator: Apr 22, 2025
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  2. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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

    Maat Senior Member (Voting Rights)

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    Just looked up who carried out the trial FMD | Physio4fmd



    Safe?!

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

     
    Last edited by a moderator: Apr 22, 2025
  4. rvallee

    rvallee Senior Member (Voting Rights)

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    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.
     
    Last edited: May 22, 2024
  5. bobbler

    bobbler Senior Member (Voting Rights)

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    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)
     
  6. dave30th

    dave30th Senior Member (Voting Rights)

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    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.
     
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  7. dave30th

    dave30th Senior Member (Voting Rights)

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  8. Hutan

    Hutan Moderator Staff Member

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  9. Hutan

    Hutan Moderator Staff Member

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    I doubt that the similarity of the name Physio4FMD with @PhysiosforME was a coincidence.
     
    Last edited: Apr 22, 2025
  10. Hutan

    Hutan Moderator Staff Member

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    I think this collection of papers add up to the 'PACE trial' of FMD. The authors have provided a lot of information.

    On page 63 of the supplementary information there is an account of Potential Diagnostic Reclassifications. This is over a period of 12 months, and the number of participants was roughly 240. It sounds as though any reclassification had to be approved by the patient's neurologist. It seems unlikely that a neurologist who had diagnosed their patient with FMD would be rushing to admit they had the diagnosis wrong.

    There was one case that they acknowledged as a diagnostic error - a degenerative neurological disease that they did not name for privacy reasons.

    There were 2 cases of new onset disease. One was described as 'an incidental finding of a small ischaemic lesion on head MRI, performed for other purposes '. We know that in MS, the lesions come and go in different part of the brain. What is more likely - that an earlier lesion affected motor function, or that the person has a functional disorder and a new onset of brain lesions? It's notable that no one was looking for the lesion, it was an incidental finding.

    The other was a new diagnosis of benign paroxysmal positional vertigo (BPPV). BPPV causes vertigo that comes and goes. The authors report that the symptoms described the the participant at baseline could not be explained by BPPV.

    One case of a prodromal diagnostic change. The person had weakness and tremor. It was eventually decided that the person had emerging Parkinsons and that the functional weakness may have been occurring as a prodrome.

    Two cases of comorbid diagnostic change. One participant had a seizure and was diagnosed with epilepsy. It was decided the person had both epilepsy and functional motor symptoms. Another participant 'underwent a neurosurgical procedure for a pre-existing lesion. The lesion was considered unlikely to account for the participants presenting symptoms'.

    There are a number of other events that are dismissed as consistent with the functional diagnoses. I think it is very likely that more of the participants would be found to have pathology that explained their FMD symptoms in subsequent years.
     
    Last edited: Apr 22, 2025
  11. Utsikt

    Utsikt Senior Member (Voting Rights)

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    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?
     
  12. Arvo

    Arvo Senior Member (Voting Rights)

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    I came here to say just this.
     
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  13. rvallee

    rvallee Senior Member (Voting Rights)

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    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.
     
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  14. dave30th

    dave30th Senior Member (Voting Rights)

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    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?
     
  15. dave30th

    dave30th Senior Member (Voting Rights)

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    regarding the cost-effectiveness paper, I'm a bit perplexed about an intervention with null results that is still found to be "cost-effective." How does that work??
     
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  16. jnmaciuch

    jnmaciuch Senior Member (Voting Rights)

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    "Our study found that staring at a wall was a cost-effective solution for type I diabetes, because staring at a wall is cheaper than insulin."
     
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  17. Utsikt

    Utsikt Senior Member (Voting Rights)

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    They divided the marginal cost relative to CAU by the marginal effect relative to CAU, and found that the cost per effect per person per year was slightly lower than the £20,000 limit that is commonly used by the government.

    I briefly looked at the calculations (but I did not double check their sources) and I believe they add up except for one number I was unable to trace in the document.

    The fatal flaw in their analysis is that they assumed that any positive effect would be meaningful regardless of the size. That is obviously not true, which is why we have MCID.

    So they are essentially arguing that the government should spend a lot of money on something that isn’t going to make any meaningful difference. I would not be surprised if you would have seen a better result of if you just gave the participants the money that the intervention cost.
     
  18. Utsikt

    Utsikt Senior Member (Voting Rights)

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    I know it’s a joke, but that calculation would probably favour insulin due to the cost of the deaths that would occur in the other group.

    Sorry, I’m an economist so I can’t stop running the numbers :banghead:
     
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  19. Sean

    Sean Moderator Staff Member

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    *As long as you ignore morbidity and mortality.
     
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  20. jnmaciuch

    jnmaciuch Senior Member (Voting Rights)

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    It seems like the only books that matter are the ones from the insurance company
     
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