Holm Lise Vilstrup, Jarbøl Dorte Ejg, Christensen Henrik Wulff, Søndergaard Jens, Hestbæk Lise
1Nordic Institute of Chiropractic and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, DK-5230 Odense M, Denmark.
2Research Unit of General Practice in Odense, University of Southern Denmark, J.B. Winsløws vej 9A, DK-5000 Odense C, Denmark.
Chiropr Man Therap. 2018 Jun 7;26:17. doi: 10.1186/s12998-018-0188-9. eCollection 2018.
Infantile colic is a common condition during early childhood affecting around one of six newborns. The condition is characterized by inconsolable crying and fussing in otherwise healthy and thriving infants. The most used definition is excessive crying for at least three hours a day for at least three days for at least three weeks. The cause of colic is still unknown although many hypotheses and thereby many different treatment modalities have been investigated. Chiropractic care is used increasingly in treatment of infants, including for infantile colic, although the evidence worldwide is sparse. A randomized, controlled trial was designed to evaluate the effect of chiropractic treatment on infantile colic. This paper describes the protocol as well as results from a pilot study examining the acceptability and feasibility of the intervention.
The study is designed as a single-blind randomized, controlled trial. The invited families are residents on the Island of Funen and information about the project is distributed from the maternity wards and health visitors. Children at the age of 2-14 weeks with unexplained excessive crying are screened for eligibility and recruited by the primary investigator through home visits. Eligible children are then randomized to chiropractic treatment or control. All children attend in the chiropractor clinic two times a week for two weeks. The parents are unaware of their child's allocation during the project period. The primary outcome measure is change in daily hours of crying based on the parental diaries.The study intends to include 200 children, and the intervention has, during a pilot study, been found acceptable and feasible among families with newborns.
In a single-blind randomized controlled design we will evaluate the effectiveness of chiropractic treatment on infantile colic. The study will contribute to determine the effect of chiropractic treatment on infantile colic in an area where limited evidence exists. Furthermore, the study aims to explore if subgroups of children with suspected musculoskeletal problems will benefit more from the intervention than others. If they obtain better results, this could imply the need for stratified care.
Clinicaltrials.gov and Identifier: NCT02595515 (registered 2 November 2015).
婴儿腹绞痛是幼儿期的一种常见病症，约六分之一的新生儿会受其影响。该病的特征是原本健康活泼的婴儿出现无法安抚的哭闹和烦躁不安。最常用的定义是每天至少哭闹三小时，且至少持续三天，为期至少三周。尽管已经对许多假说以及由此产生的许多不同治疗方式进行了研究，但腹绞痛的病因仍然不明。整脊疗法越来越多地用于婴儿治疗，包括治疗婴儿腹绞痛，不过全球范围内这方面的证据很少。一项随机对照试验旨在评估整脊疗法对婴儿腹绞痛的疗效。本文描述了该试验方案以及一项初步研究的结果，该初步研究考察了该干预措施的可接受性和可行性。
该研究设计为单盲随机对照试验。受邀家庭为菲英岛的居民，有关该项目的信息从产科病房和健康访视员处分发。由初级研究者通过家访对2至14周大、有不明原因过度哭闹的儿童进行资格筛查并招募。符合条件的儿童随后被随机分为接受整脊疗法治疗组或对照组。所有儿童每周到整脊诊所就诊两次，为期两周。在项目期间，家长不知道自己孩子的分组情况。主要结局指标是根据家长日记记录的每日哭闹时长的变化。该研究计划纳入200名儿童，并且在一项初步研究中发现，该干预措施在有新生儿的家庭中是可接受且可行的。
在单盲随机对照设计中，我们将评估整脊疗法对婴儿腹绞痛的疗效。该研究将有助于在证据有限的领域确定整脊疗法对婴儿腹绞痛的效果。此外，该研究旨在探讨怀疑有肌肉骨骼问题的儿童亚组是否比其他儿童从该干预措施中获益更多。如果他们获得更好的结果，这可能意味着需要分层护理。
Clinicaltrials.gov，标识符：NCT02595515（2015年11月2日注册）。
