UNASSIGNED: Drawing on the principles of wrist-ankle acupuncture (WAA), our research team has developed a portable device for WAA point compression, termed the acupressure wrist-ankle strap (AWA). The current study aims to evaluate the efficacy of the AWA in alleviating pain associated with primary dysmenorrhea.
UNASSIGNED: A single-blind, randomized clinical trial was conducted from April 1, 2019, to December 31, 2019. 78 participants with primary dysmenorrhea were recruited from Shanghai University of Traditional Chinese Medicine. All participants were treated on the first day of menstruation for 30 min. Participants in the AWA group used the AWA, the internal side of which is equipped with a tip compression component, while participants in the non-acupressure wrist-ankle acupuncture(NAWA)group used the NAWA, with the inside tip pressing parts removed. The main outcome was the difference in visual analogue scale (VAS) score between baseline and 30 minutes after randomization.
UNASSIGNED: A total of 78 participants aged 18 to 30 years were included in the intention-to-treat analyses. The VAS scores (mean [standard deviation]) in the AWA group were significantly lower than those in the NAWA group at each time point of intervention (5 minutes: 95% CI, [-1.27 to -0.68], p < 0.001; 10 minutes: 95% CI, [-2.34 to -1.51], p < 0.001; 30 minutes: 95% CI, [-3.74 to -2.72], p < 0.001). In the AWA group, 16 participants reported \"obvious relief\" of dysmenorrhea pain while 23 did not; the average onset time of analgesia they reported were (21.50 ± 3.65) min, while no subjects in NAWA group reported obvious pain relief. The pain threshold (mean [standard deviation]) at SP9 of both sides in AWA group decreased significantly after intervention that in NAWA group (Left: 95% CI, [-5.02 to -1.81], p < 0.001; Right: 95% CI, [-7.67 to -4.24], p < 0.001). There was no significant change in the temperature at CV4 in either group (95% CI, [-0.63 to -0.66], p = 0.970).
UNASSIGNED: This trial substantiates our hypothesis that the AWA provides immediate analgesic effects. The AWA represents an effective and safe non-invasive physical therapy option, which patients can self-administer to alleviate abdominal pain.

BACKGROUND: Insomnia is very common in current society, and patients are often accompanied by a certain degree of anxiety, depression, etc. Recent studies have found that the hypothalamic-pituitary-adrenal (HPA) axis excitement-inhibition state is an important indicator of sleep quality. Wrist-ankle acupuncture (WAA) is safe and effective for insomnia. Based on WAA theory, the acupressure wrist-ankle straps are portable WAA point compression straps that can treat diseases by automatically applying pressure to the treatment location and being operated by patients themselves. We design this trial to evaluate the clinical effect of the acupressure wrist-ankle strap in the treatment of mild insomnia patients with anxiety disorders.
METHODS: This trial is a parallel-design, patients-assessor blinded, randomized, sham-controlled. In total, 114 patients diagnosed with mild insomnia and anxiety disorders will be randomly assigned into two groups, the acupressure wrist-ankle strap group or the non-acupressure wrist-ankle strap group; they will receive treatments for eight weeks with five sessions each week. Rating scales, sleep monitors, and laboratory tests will be used to observe the clinical effect. From the perspective of the circadian secretion of peripheral blood-related hormones in the hypothalamic-pituitary-adrenal (HPA) axis, the possible mechanism of acupressure wrist-ankle straps for treating insomnia is studied.
CONCLUSIONS: The results of this study will confirm the efficacy of acupressure wrist-ankle strap in treating mild insomnia patients with anxiety disorder and whether its mechanism is related to the HPA axis. The acupressure wrist-ankle strap may become a pure physical, no side effect treatment of mild insomnia.
BACKGROUND: Chinese Clinical Trial Registry ChiCTR2000039352 . Registered on 24 October 2020.