Abstract
BackgroundEven though chronic fatigue syndrome and idiopathic chronic fatigue are quite common, there are no clearly known causes. Most treatments are therefore symptomatic in nature, and chronic fatigue syndrome and idiopathic chronic fatigue patients are highly interested in using oriental medicine or complementary and alternative medicine treatment. Acupuncture, one of the major treatments used in oriental medicine, is effective in treating various diseases. This study will attempt to analyze the effectiveness and safety of acupuncture in the treatment of chronic fatigue by comparing the two treatment groups (body acupuncture, Sa-am acupuncture) and the control group (usual care).Methods/designThis study consists of a four-center, three-arm, randomized, controlled, and open-label trial. One hundred and fifty participants are randomly divided into treatment groups A and B and a control group. The treatment groups will receive acupuncture treatments either two or three times per week for a total of 10 sessions over a period of 4 weeks. The control group will not receive acupuncture treatments and will continue their usual care during this period. The primary outcome variable is the Fatigue Severity Scale, which will be utilized 5 weeks after randomization. Secondary outcome variables are the Fatigue Severity Scale at 13 weeks, a short form of the Stress Response Inventory, the Beck Depression Inventory, the Numeric Rating Scale, and the EuroQol-5 Dimension at 5 and 13 weeks after randomization.DiscussionThis study will provide evidence with high external validity on the effectiveness and safety of acupuncture as a treatment for chronic fatigue syndrome and idiopathic chronic fatigue.Trial registrationClinical Research Information Service KCT0000508
Highlights
Even though chronic fatigue syndrome and idiopathic chronic fatigue are quite common, there are no clearly known causes
Indescribable cases of chronic fatigue can be classified into chronic fatigue syndrome (CFS) and idiopathic chronic fatigue (ICF) [3]
The aim of this study is to provide grounds for the effectiveness and safety of acupuncture by comparing the two acupuncture treatment groups and the control group
Summary
Even though chronic fatigue syndrome and idiopathic chronic fatigue are quite common, there are no clearly known causes. The symptoms associated with a diagnosis of CFS include unexplained fatigue, lasting longer than 6 months, new or definite onset, fatigue that does not result from ongoing exertion and is not substantially alleviated by rest, and a substantial reduction in previous levels of occupational, educational, social, or personal activities. In addition to these symptoms, more than four of the following symptoms should be concurrently present over 6 months: impaired memory or concentration, sore throat, tender cervical or axillary lymph nodes, muscle pain, multi-joint pain, onset of new headaches, unrefreshing sleep, and post-exertion malaise. If a patient does not meet all the criteria for CFS described above, he/she is diagnosed with ICF [5]
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