Time-effective analgesic effect of acupressure ankle strip pressing wrist and ankle acupuncture point on primary dysmenorrhea: Study protocol clinical trial (SPIRIT compliant).

BACKGROUND: Dysmenorrhea seriously affects the ability of women to perform normal social activities and decreases their quality of life. Primary dysmenorrhea can be effectively treated with acupuncture. Based on the wrist-ankle acupuncture (WAA) theory, we designed a portable WAA point compression treatment strap that treats diseases by automatically applying pressure to acupuncture points. The proposed study aims to evaluate the immediate analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. METHODS: The study will be a randomized controlled trial conducted from May 1, 2019 to May 30, 2020 that includes 78 students from Shanghai University of Traditional Chinese Medicine who have primary dysmenorrhea and meet the eligibility criteria. Participants will be randomly divided into 2 groups in a 1:1 allocation ratio. The intervention group will use the acupressure wrist-ankle strap equipped with tip compression component parts on the internal side; the control group will use the nonacupressure wrist-ankle strap with the tip compression parts removed. All participants will be treated for 30 minutes on the 1st day of menstruation. The primary outcome is the pain intensity score measured by the visual analog scale. The secondary outcomes are the onset time of analgesia, the pain threshold at Yinlingquan (SP 9), skin temperature at Guanyuan (CV 4), and expectations and satisfaction of patients as investigated via the expectation and treatment credibility scale. DISCUSSION: This trial will be the 1st study to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. The quality of this study is ensured by the randomization, nonacupressure control, and blinded design. The results may provide evidence for a potential alternative treatment for primary dysmenorrhea and evidence-based proof of the analgesic effect of WAA.