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

Vollständiger Abstract

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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.