Protocol Effectiveness of Tuina Therapy for pwCFS: Protocol for Multicenter, Randomized, Open-Label, Assessor-Blinded, Parallel-Group Clinical Trial, 2026, Ren

[Chandelier]

Effectiveness of Tuina Therapy for Patients With Chronic Fatigue Syndrome: Protocol for a Multicenter, Randomized, Open-Label, Assessor-Blinded, Parallel-Group Clinical Trial

Spoiler: Authors

Ren, Jun; Wang, Shoujian; Fang, Sitong; Xu, Shanda; Xie, Chaoqun; Jin, Ming; Zhou, Xingyu; Li, Wu; Zhao, Yan; Wu, Xingquan; Wang, Cheng; Wang, Yanguo; Gong, Zhichao; Zhou, Jing; Yao, Junjie; Bai, Xue; Wang, Yu; Fang, Min; Kong, Lingjun

Abstract​

Background: Chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME), is a debilitating condition characterized by persistent fatigue and a range of complex accompanying symptoms. While curative treatments remain limited, Tuina (a traditional manual therapy in Chinese medicine) has shown potential in alleviating fatigue in pilot studies. However, high-quality evidence from large-scale, multicenter trials regarding its efficacy and long-term sustainability is lacking.

Objective: This trial aims to evaluate the efficacy and safety of Tuina combined with usual care (UC) for CFS compared with UC alone.

Methods: This prospective, multicenter, randomized, open-label, assessor-blinded, parallel-group clinical trial will be conducted at 6 hospitals in China. The study consists of 3 phases: a 1-week run-in period, an 8-week treatment period, and a 24-week follow-up period. A total of 230 eligible participants diagnosed with CFS (Centers for Disease Control and Prevention 1994 criteria) will be recruited and randomly allocated (1:1) to receive either Tuina therapy plus UC (intervention group) or UC alone (control group). The intervention group will undergo 24 sessions of a standardized Tuina protocol over 8 weeks (3 sessions/week). Follow-up assessments will be conducted at weeks 4, 8, 20, and 32. The primary outcome is the change in fatigue severity measured by the 11-item Chalder Fatigue Questionnaire from baseline to week 8. Secondary outcomes include clinical response rate, sleep quality, anxiety, depression, quality of life, adverse events, and clinical global impression. Efficacy analysis will be performed using a mixed-effects model for repeated measures in the modified intention-to-treat population. Secondary outcomes will be analyzed as exploratory supportive end points using appropriate parametric or nonparametric tests based on data distribution, with week 8 defined as the main secondary time point and later follow-up visits interpreted as durability contrasts. Missing outcome data will be handled primarily through likelihood-based mixed-model estimation under a missing-at-random assumption, with multiple imputation and per-protocol analyses used as sensitivity analyses.

Results: Recruitment for this trial will start in March 2026 and is expected to be completed by March 2027. The results of this study are expected to provide reliable evidence regarding the role of Tuina in the management of CFS.

Conclusions: This multicenter randomized controlled trial will evaluate the effectiveness, long-term sustainability, and safety of Tuina therapy plus UC for improving fatigue, sleep, mood, and quality of life in CFS or ME. If proven beneficial, Tuina may serve as a scalable nonpharmacological option to support clinical decision-making and standardized implementation.

Trial Registration:
International Traditional Medicine Clinical Trial Registry ITMCTR2025001706; https://itmctr.ccebtcm.org.cn/mgt/project/view/1966088675536273408

International Registered Report Identifier (IRRID): PRR1-10.2196/94022

Web | DOI | PMC | PDF | JMIR Research Protocols | Open Access

 

[Chandelier]

From Twitter / XCancel:

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Mark Vink, MD @Huisarts_Vink

First we had the LP trial, now we have another badly designed trial (TUINA)
1. Fukuda criteria;
2. Non-blinded, subjective primary and secondary outcomes;
3. Badly designed control group (usual care).
More research money is being wasted

#MEcfs

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[Hutan]

However, high-quality evidence from large-scale, multicenter trials regarding its efficacy and long-term sustainability is lacking.

so...

This prospective, multicenter, randomized, open-label, assessor-blinded, parallel-group clinical trial will be conducted at 6 hospitals in China.

Because adding more rubbish, in fact adding a big amount of rubbish, onto the pile of existing rubbish makes ...."high-quality evidence"?

 

[dave30th]

Tuina Therapy

I saw this at a glance and misread it and thought "tuna therapy"? Eating lots of tuna? Maybe the mercury in tuna turns out to be good for us???

 

[Maat]

Tuina Massage: Benefits, Techniques, and More

Tuina massage is an ancient Chinese practice that practitioners claim can treat a range of musculoskeletel ailments. Learn more here.

www.healthline.com

Essentially Acupuncture but without needles aimed at an eastern philosophy, so complementary therapy.

The nearest western equivalent I think would be reflexology.

Side effects
Tuina massage is a safe treatment and is generally well-tolerated. However, remember that it’s not a gentle or relaxing massage, and you may feel some discomfort during or after a session. Slight bruising is possible.

It’s not recommended for people who have fractures or are prone to fractures, vein inflammation, or any type of open wound. It’s also not recommended for people with chronic back issues, such as ankylosing spondylitis.

 

[Maat]

I saw this at a glance and misread it and thought "tuna therapy"? Eating lots of tuna? Maybe the mercury in tuna turns out to be good for us???

so did I.

 

[MrMagoo]

so did I.

I was worried because I’m vegetarian and I hate fish

 

[rvallee]

so...


Because adding more rubbish, in fact adding a big amount of rubbish, onto the pile of existing rubbish makes ...."high-quality evidence"?

There used to be 4 rubbish trials. Now there are 5. Progress!

 

[rvallee]

Congratulations to the luminaries in the evidence-based medicine and psychobehavioral movements. This is what you built, they're doing it exactly like you, with the same intent and indifference to outcomes, process or pretty much anything. All spiritual ego, no science.

The thing about reactionary politics is that it always happens the same way: they get everything they want and hate everything about it. Psychosomatic ideology is and will always be reactionary, a preference for dumb, false explanations that make no sense but makes their proponents feel superior.

 

[Utsikt]

This prospective, multicenter, randomized, open-label, assessor-blinded, parallel-group clinical trial will be conducted at 6 hospitals in China.

The primary outcome is the change in fatigue severity measured by the 11-item Chalder Fatigue Questionnaire from baseline to week 8. Secondary outcomes include clinical response rate, sleep quality, anxiety, depression, quality of life, adverse events, and clinical global impression.

It seems like there is a recent trend of claiming that something is «assessor-blinded» if the people assessing the outcome data are blinded. Surely the assessor is the one that is reporting the outcome - i.e. the participant - and they are not blinded.