PDF(Pubmed)
Abstract：
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.
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.
摘要：
背景：失眠在当今社会非常普遍，患者往往伴有一定程度的焦虑，抑郁症,等。近年来研究发现,下丘脑-垂体-肾上腺(HPA)轴兴奋抑制状态是睡眠质量的重要指标。腕踝针治疗失眠安全有效。基于WAA理论,指压腕踝带是便携式WAA点压缩带，可以通过自动向治疗位置施加压力并由患者自己操作来治疗疾病。本试验旨在评价指压腕踝带治疗轻度失眠伴焦虑障碍患者的临床疗效。
方法：该试验是并行设计，患者-评估者失明，随机化，假控制。总的来说,114名诊断为轻度失眠和焦虑症的患者将被随机分为两组，指压腕踝带组或非指压腕踝带组；他们将接受为期八周的治疗，每周五次。评级量表，睡眠监视器，和实验室检查将用于观察临床效果。从下丘脑-垂体-肾上腺（HPA）轴的外周血相关激素的昼夜节律分泌的角度来看，研究了指压腕踝带治疗失眠的可能机制。
结论：本研究结果将证实指压腕踝带治疗轻度失眠伴焦虑症患者的疗效及其机制是否与HPA轴有关。指压腕踝带可能成为一个纯粹的物理，治疗轻度失眠无副作用。
背景：中国临床试验注册ChiCTR2000039352。于2020年10月24日注册。
方法：该试验是并行设计，患者-评估者失明，随机化，假控制。总的来说,114名诊断为轻度失眠和焦虑症的患者将被随机分为两组，指压腕踝带组或非指压腕踝带组；他们将接受为期八周的治疗，每周五次。评级量表，睡眠监视器，和实验室检查将用于观察临床效果。从下丘脑-垂体-肾上腺（HPA）轴的外周血相关激素的昼夜节律分泌的角度来看，研究了指压腕踝带治疗失眠的可能机制。
结论：本研究结果将证实指压腕踝带治疗轻度失眠伴焦虑症患者的疗效及其机制是否与HPA轴有关。指压腕踝带可能成为一个纯粹的物理，治疗轻度失眠无副作用。
背景：中国临床试验注册ChiCTR2000039352。于2020年10月24日注册。
