Protocol Comparing effectiveness of physiotherapy vs drug management on fatigue, physical functioning, and episodic disability for [ME] in [PCC]... 2024 Sarker

Full title: Comparing effectiveness of physiotherapy versus drug management on fatigue, physical functioning, and episodic disability for myalgic encephalomyelitis in post-COVID-19 condition: a study protocol of randomized control trial

Abstract

Background
Physiotherapy interventions effectively improved fatigue and physical functioning in non-COVID patients with myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS). There is a research gap on the effectiveness of physiotherapy interventions versus drug management on ME/CFS in post-COVID-19 conditions (PCC).

Methods
We planned a three-arm prospective randomized control trial on 135 PCC cases with ME/CFS who are diagnosed between 20 November 2023 and 20 May 2024 from a population-based cohort. The study aims to determine the effectiveness of physiotherapy interventions as adapted physical activity and therapeutic exercise (APTE) provided in institution-based care versus telemedicine compared with drug management (DM). Participants will be assigned to three groups with the concealed location process and block randomization with an enrollment ratio of 1:1:1. The post-treatment evaluation will be employed after 2 months of interventions, and follow-up will be taken after 6 months post-intervention. The Chalder fatigue scale will measure the primary outcome of fatigue. SF-36 and the disability-adjusted life years (DALYs) will measure the secondary outcome of physical functioning and episodic disability.

Discussion
This study will address the research gap to determine the appropriate approach of physiotherapy or drug management for ME/CFS in PCC cases. The future direction of the study will contribute to developing evidence-based practice in post-COVID-19 condition rehabilitation.

Open access, https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08077-x

 

"The proposed study will be a three-arm randomized clinical trial (RCT) of PCC patients diagnosed with ME/CFS according to WHO working group criteria1"

Reference given is to WHO: A clinical case definition of post COVID-19 condition by a Delphi consensus

"The sample size was calculated using the software ClinCalc [27], and the key primary outcome was determined as the score of fatigue in the Chalder fatigue scale (CFS)"

 

(Citing the PACE trial and other GET studies)

?? How can they ask for people who fit the CCC but exclude PEM (PESE). Or does “preexisting” here mean PESE before the covid infection?

As far as I can tell, no mention of people being possibly too severe to participate, which isn’t a good sign.

 

I think it might be the second because they say this - they expect people to experience PESE during the study.

 

no objective endpoints/ measures
same old GIGO

 

https://twitter.com/user/status/1791083096760054244

 

Do they realise the GET study they are citing (PACE trial) had double the amount of adverse effects in GET compared to control and that was with a sample that didn’t require PEM

 

No they don't. So the entire premise of this "study" is invalid. They are comparing ineffective things with other ineffective things, something that deserves to be mocked mercilessly. Might as well compare with potatoes for all that this matters. As in having potatoes deliver whatever personalized patient-centered holistic treatment they can think of. Same difference.

And a primary outcome of CFQ? Good grief, how is this junk still getting funded?

Not that it's especially worse than the usual. In fact, there is basically no significant difference between this and PACE, it's just differently inept.

 

Yeah, I somehow feel these authors might be more open to constructive criticism than some of the UK BPS crowd. I hope someone will have the energy to send them something.

 

From what I can see there is no control group of any sort either

it’s exercise in an institution, exercise via telemedicine vs drugs.

I don’t know the exact appropriate control given the design flaws of choosing to do no objective measures etc too but my goodness this is like the forced choice between three bad therapies in theory recently if they are rubbish drugs? So in that case could be worse than comparing to ‘give nothing’ if the drugs send people backwards?

 

I can’t copy quotes from this using my phone - can someone scroll down to the drug management section under methodology and do so if they get there before I’m up to looking at this another way?

I’m pretty shocked by it as there is a long list of about 8 meds many of which are hard core (and seem unusual to be all taken together by so many?) including rituximab snd hydrocortisone among two examples

also shocked by the fact they intend to allow the drug ‘controls’ to participate in the exercise programme if they want to

so where is the control?

EDIT: I've copy-pasted the quotes in the next comment. BUt the list of meds is:

azithromycin, remdesivir, favipiravir, infliximab, tocilizumab, siltuximab, hydrocortisone, rituximab, rintatolimod, and intravenous immunoglobulin

I've checked to see there isn't wording saying 'a selection from...' or something in the section itself but not read the whole paper forensically yet.

That seems unusual to take a number of 'imabs'?

 

Here it is (my bolding on the 'drug controls can join in the exercise programme' bit):

and also

 

Holy cow, that's a lot of drugs. There's no way, right? I feel like this has to be poor wording choice.

Edit: I assume the "and" is supposed to be "or". And that the physician will decide which to prescribe.

 

Not only that but: “The original questionnaire was formulated in English. Then, a bilingual researcher who is not involved in this study project translates forward Bangla to backward English.”

As you say, what could possibly go wrong?

The whole thing reads like a satire.

Do we know who is funding this study? How could any scientifically literal person take this seriously?