Aim Congenital nasolacrimal duct obstruction (CNLDO) is the most common cause of epiphora and mucous discharge in the newborn. We conducted a multicentre randomised controlled trial to determine whether Crigler massage promotes the resolution of CNLDO in infants under 1 year of age. Methods A total of 102 infants aged 3–11 months with unilateral CNLDO were enrolled in the study. Patients were randomly assigned to the massage and non-massage groups (n=51/group). As an allocation adjustment factor, the patients were divided into age groups of 3–5, 6–8 and 9–11 months. In the massage group, the guardian performed 10 strokes two times per day for each day until resolution or 1 month. The primary endpoint was a comparison of the 1-month resolution rate in the massage and non-massage groups. Results This study included 49 male and 53 female patients with a mean age of 6.4±2.4 months. Overall, in this study, the resolution rate was not significantly different between the massage and non-massage groups (31.4% and 33.3%, respectively). However, the resolution rate was higher in the massage group in the 3–5 months age group among the protocol-compliant patients after excluding those with insufficient massage frequency (the massage group, 68.8% and the non-massage group, 28.6%, p=0.022). Conclusions There was no increase in the resolution rate after 1 month of lacrimal sac massage in patients 3–11 months old with unilateral CNLDO. However, in protocol-compliant younger age groups, Crigler massage may be effective. Trial registration number UMIN Clinical Trial Registry (UMIN000032840; [www.umin.ac.jp/][1]). Data are available upon reasonable request. The trial protocol and the data supporting the findings of this study are available from the corresponding author upon reasonable request. [1]: http://www.umin.ac.jp/

中文翻译：

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先天性鼻泪管梗阻的泪囊按摩：一项多中心随机对照试验


目的 先天性鼻泪管梗阻 （CNLDO） 是新生儿溢血和粘液分泌物的最常见原因。我们进行了一项多中心随机对照试验，以确定 Crigler 按摩是否促进 1 岁以下婴儿 CNLDO 的消退。方法 共纳入 102 例 3-11 个月单侧 CNLDO 婴儿。患者被随机分配到按摩组和非按摩组 （n=51/组）。作为分配调整因素，将患者分为 3-5 、 6-8 和 9-11 月龄的年龄组。在按摩组中，监护人每天进行 2 次 10 次敲击，每天 2 次，直到消退或 1 个月。主要终点是比较按摩组和非按摩组的 1 个月消退率。结果 本研究包括 49 例男性和 53 例女性患者，平均年龄为 6.4±2.4 个月。总体而言，在本研究中，按摩组和非按摩组之间的消退率没有显著差异 （分别为 31.4% 和 33.3%）。然而，在排除按摩频率不足的患者后，在符合方案的患者中，3-5 个月年龄组按摩组的消退率更高 （按摩组，68.8%，非按摩组，28.6%，p=0.022）。结论 3-11 月龄单侧 CNLDO 患者泪囊按摩 1 个月后消退率无增加。然而，在符合协议的年轻群体中，Crigler 按摩可能有效。试验注册号 UMIN 临床试验注册处 （UMIN000032840;[www.umin.ac.jp/][1]）。数据可根据合理要求提供。 试验方案和支持本研究结果的数据可应合理要求从通讯作者处获得。[1]：http://www.umin.ac。日本/