JMIR Publications

ABSTRACT

Background:

Chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME), is a debilitating condition characterised 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, randomised, open-label, assessor-blinded, parallel-group clinical trial will be conducted at six hospitals in China. The study consists of three 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 (CDC 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 standardised 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 Chalder Fatigue Questionnaire (CFQ-11) from baseline to week 8. Secondary outcomes include response rate, sleep quality, anxiety, depression, quality of life, adverse events, and clinical global impression. Efficacy analysis will be performed using a Mixed Model for Repeated Measures (MMRM) in the Intention-to-Treat (ITT) population. Secondary outcomes will be analyzed using appropriate parametric or non-parametric tests based on data distribution.

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/ME. If proven beneficial, Tuina may serve as a scalable non-pharmacological option to support clinical decision-making and standardized implementation. Clinical Trial: ITMCTR2025001706 (International Traditional Medicine Clinical Trial Registry, https://itmctr.ccebtcm.org.cn, registered on 26 August 2025); preresults.