Effect of Tuina combined with Chinese herbal compress on primary dysmenorrhea with cold coagulation and blood stasis syndrome, study protocol for a randomized controlled trial

Background: Primary dysmenorrhea (PD) is a very common problem in young women, which reduces the quality of women’s lives. Both western medicine and TCM provide several ways to treat PD; however, TCM treatment has fewer side effects for the patient. Tuina and Chinese herbal compresses are considered forms of external TCM therapy, which has been widely used to treat PD, especially in China. Therefore, to provide the most effective and safe treatment for PD, we combined Tuina and Chinese herbal compresses together in this research and observation. Method: /design: A randomized controlled trial (RCT) consisting of 114 participants from the Shanghai University of Traditional Chinese Medicine who meet inclusion criteria will be divided into 2 groups in a 1:1 allocation ratio. The intervention group will receive Tuina combined with Chinese herbal compress therapy; the control group will only receive Chinese herbal compress therapy. The treatment will be given three days before menstruation (once a day, three times per menstrual cycle). The primary outcome was measured by the visual analog scale (VAS). The secondary outcomes were measured by the dysmenorrhea symptom score, the Chinese medical dysmenorrhea symptom score, the self-rating anxiety scale (SAS), the self-rating depression scale (SDS), and the pain threshold at Guanyuan acupoint (CV4). Discussion: The study will be the first randomized controlled trial observing the combination of Tuina and Chinese herbal compresses to treat PD in the category of cold coagulation and blood stasis syndrome. If the results demonstrate that Tuina combined with a Chinese herbal compress is effective, this study may provide evidence-based references for a potential alternative treatment to treat PD in the future. Trial registration: ChiCTR Registry, ChiCTR2300069527, Registered on 20 March 2023.