Dose-Effect of Long-Snake-Like Moxibustion for Chronic Fatigue Syndrome: Study Protocol for a Randomized Controlled Trial [post]

Tingting Ma, Rui Gong, Rui Zheng, Jie Wu
2021 unpublished
Background Chronic fatigue syndrome (CFS) is a disease with high incidence rate and great impact on life, but it lacks for specific pharmacological treatment and diagnostic indicators. In the theory of traditional Chinese medicine (TCM), fatigue is the result of Yang deficiency. Long-snake-like moxibustion, as one of a special moxa therapy, has been applied in Yang deficiency patients for thousands of years in China and it is used widely to relieve fatigue symptoms for its strong function of
more » ... rong function of Yang warming. However, the does-effect relationship is unclear in the moxibustion research. Hence, we design this trial to assess the duration-effect of long-snake-like moxibustion through combining measurements of the subjective patient-reported scales with objective medical infrared imaging technology─Thermal Texture Maps (TTM). Methods This is a single-center, randomized controlled trial. Thirty healthy women and sixty female CFS patients will be recruited to receive the first TTM scanning, then CFS patients will be allocated to 60-minute long-snake-like moxibustion (Group A) and 30-minute long-snake-like moxibustion (Group B) equally. These two groups will receive corresponding treatment once a day, three sessions per week every other day for consecutive 4 weeks. The second TTM scanning will be employed for CFS patients after the end of treatment. The primary outcome will be the score improvement of the Fatigue scale-14 (FS-14). Secondary outcomes include the change of the Self-rating depression scale (SDS),the Self-rating anxiety scale (SAS), and the Symptoms Scale of spleen-kidney Yang deficiency. Discussion The trial will provide evidence for the choice of treatment duration for long-snake-like moxibustion in treating CFS. The results will contribute to explore the dose-effect relationship of moxibustion, and optimize the efficacy of moxibustion therapy. Trial registration: Chinese Clinical Trail Registry (No. ChiCTR2000041000), on 16th December, 2020, http://www.chictr.org.cn/showproj.aspx?proj=62488
doi:10.21203/rs.3.rs-267403/v1 fatcat:suoxuvmkajdepgr6sm5a5x4ug4