Testing the Feasibility of ... Lymphatic Drainage to Reduce Fatigue-Related Symptoms Among Patients with [LC] 2025 Perrin, Heald et al

Andy

Senior Member (Voting rights)
Full title: Testing the Feasibility of a Self-Help Intervention That Includes Lymphatic Drainage to Reduce Fatigue-Related Symptoms Among Patients with Long COVID in General Practice: Experiences from Our Randomized Controlled Trial (RCT)

Abstract

Introduction
Long COVID-related fatigue affects a large number of people across the world, with increasing numbers of people experiencing long-term disability as a consequence. We tested the feasibility of a self-help version of a manual osteopathic approach initially developed for people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) to treat people with long COVID-related fatigue.

Methods
Our feasibility study assessed recruitment into a 1:1 randomized controlled trial (RCT) to receive (i) self-help intervention (self-massage, mobility, flexibility, and breathing exercises, and alternating cold and warm packs to the top of the spine) or (ii) wait-list control group. Follow-up was assessed by online surveys at 3 and 6 months (indicating retention). Verbal feedback was obtained from participants.

Results
Of the 138 eligible survey participants, 126 (90.6%) agreed to participate in two RCTs, achieving the required sample size of 100. Follow-up rates of 79.3% and 59.4% were achieved at 3 and 6 months, respectively. Improvements in Chalder Fatigue Questionnaire (CFQ) scores were observed in both groups between 0 and 3 months (− 4.6 and − 2.9, respectively), to a greater degree in the intervention group (p = 0.01). Feedback showed a cohort keen to engage with the intervention, although some found the intervention onerous at times.

Conclusions
We have reported the results of a feasibility study examining a potentially beneficial intervention for people with long COVID. There were indications of benefit in a patient group with often intractable symptoms. Based on this feasibility study, we believe that the low-cost self-help intervention in isolation could help support fatigue reduction in some people. This has implications for the treatment of both long COVID and ME/CFS.

Open access
 
Of the 138 eligible survey participants, 126 (90.6%) agreed to participate in two RCTs, achieving the required sample size of 100. Follow-up rates of 79.3% and 59.4% were achieved at 3 and 6 months, respectively. Improvements in Chalder Fatigue Questionnaire (CFQ) scores were observed in both groups between 0 and 3 months (− 4.6 and − 2.9, respectively), to a greater degree in the intervention group (p = 0.01).
It seems like the authors have forgotten what the purpose of an RCT is: to compare the differences between the groups.

The CFQ is a scale from 0-33. The between group difference (with a waitlist control) was 1.7. That’s 5 % of the scale, and can hardly be classified as significant.

Therefore, the trial demonstrated that there is no reason to think that the intervention has any meaningful benefits.

Edit: using subjective outcomes without blinding is also an obvious issue..
 
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Therefore, the trial demonstrated that there is no reason to think that the intervention has any meaningful benefits.
With a drop out rate of nearly half of its participants and those that stayed showing really minimal impact it could very well be harmful. High drop out rates are always concerning and often correlated with reported worsening in condition.
 
It seems like the authors have forgotten what the purpose of an RCT is: to compare the differences between the groups.
I think they try to down play the feeble between group difference in outcome by claiming it's a feasibility study. And not reporting on secondary outcome measures.
The so called treatment seems to be a mix of self massage, breathing exercises and hot and cold on the upper spine. So even if they found it was useful, they have no idea which bit of this mish mash is producing an effect. I can't imagine why this was funded and promoted to pwLC.
 
Isn't this the comparison between groups: "to a greater degree in the intervention group (p = 0.01)."
Yes, but that’s hardly a meaningful comparison.
I think they try to down play the feeble between group difference in outcome by claiming it's a feasibility study.
It was registered as a feasibility study, but I agree that it sounds like an excuse for doing yet another trial later because this wasn’t large enough or whatever.

It was supposed to finish late 2023, so it took them two years to publish.

The protocol said they asked the participants to fill in a diary to assess adherence, but I can’t find any mention of it in the publication.

The protocol also said all of the data would be published along the article, but they have changed that to upon reasonable requests.

They have also deviated from the protocol with regards to the analysis.

Overall, this effort wouldn’t get a passing grade at an intro to trial design for undergrads. Complete amateurism..

Protocol:
 
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