Department of Traditional Chinese Medicine, Naval Medical University, No. 800 Xiang Ying Road, Yangpu District, Shanghai, 200433, China.
Department of Acupuncture and Moxibustion, the First Affiliated Hospital of Naval Medical University, No. 168 Chang Hai Road, Yangpu District, Shanghai, 200433, China.
Trials. 2021 Nov 4;22(1):770. doi: 10.1186/s13063-021-05725-4.
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/DESIGN: 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.
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.
Chinese Clinical Trial Registry ChiCTR2000039352 . Registered on 24 October 2020.
失眠在当前社会非常普遍，患者常伴有一定程度的焦虑、抑郁等。最近的研究发现，下丘脑-垂体-肾上腺（HPA）轴兴奋-抑制状态是睡眠质量的一个重要指标。腕踝针（WAA）治疗失眠安全有效。基于 WAA 理论，指压腕踝带是一种便携式的 WAA 点按压带，通过自动向治疗部位施加压力并由患者自行操作来治疗疾病。我们设计这项试验是为了评估指压腕踝带在治疗伴有焦虑障碍的轻度失眠患者中的临床疗效。
方法/设计：这是一项平行设计、患者评估者设盲、随机、假对照试验。共有 114 名被诊断为轻度失眠和焦虑障碍的患者将被随机分为指压腕踝带组或非指压腕踝带组，每组 57 例；他们将接受为期 8 周、每周 5 次的治疗。使用评定量表、睡眠监测仪和实验室检查来观察临床疗效。从下丘脑-垂体-肾上腺（HPA）轴外周血相关激素的昼夜分泌角度，研究指压腕踝带治疗失眠的可能机制。
本研究的结果将证实指压腕踝带治疗伴有焦虑障碍的轻度失眠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种纯物理、无副作用的轻度失眠治疗方法。
中国临床试验注册中心 ChiCTR2000039352 号。注册于 2020 年 10 月 24 日。
