Usual light touch osteopathic treatment versus simple light touch without intent in the reduction of infantile colic crying time: A randomised controlled trial

IF 1.1 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL International Journal of Osteopathic Medicine Pub Date : 2024-01-04 DOI:10.1016/j.ijosm.2024.100710
Dawn Carnes , Philip Bright , Kevin Brownhill , Karen Carroll , Roger Engel , Sandra Grace , Steven Vogel , Paul Vaucher
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Abstract

Background

Many parents seek osteopathic care for their infants with colic. Our aim was to test the effectiveness of usual light touch osteopathic treatment on crying time for infants with ‘colic’.

Methods

A superiority, two arm, single blinded (parent) multi-centre (UK, Australia and Switzerland), randomised controlled trial, included healthy infants between 1 and 69 days of age who excessively cried, fussed, or were distressed and difficult to console. The Test intervention consisted of usual light touch osteopathic treatment, the Control intervention simple light touch to random body locations with no treatment intent. Both groups received best practice advice and guidance. The primary outcome was the daily crying time, reported hourly by parents in a diary, for two-weeks. Secondary outcomes were parenting confidence, global change, satisfaction, and experience of care.

Results

Sixty-six infants were recruited (32 Test: 34 Control group). Mean average daily crying time in the Test group was 124 min (SD = 69, n = 26) and in the Control 115 min (SD = 49, n = 29). After adjustment, infants in the Test group cried 2.2 min more per day than those in the Control group (CI95 % −20 to 25 min, p = 0.849). Parents’ perceptions of global change in symptoms, satisfaction with, and experience of care were high and similar in both groups. There were no serious adverse events related to the treatments or the trial.

Conclusion

Usual light touch osteopathic treatment was not superior to simple light touch without treatment intent. The biomechanical explanatory models and underpinning assumptions about the mechanisms of osteopathic intentional light touch care may require reconsideration.

Trial registration

ACTRN12620000047998 (January 22, 2020).

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在减少婴儿肠绞痛哭闹时间方面,普通轻触式整骨疗法与无意识的简单轻触式整骨疗法的比较:随机对照试验
背景许多家长会为患有肠绞痛的婴儿寻求整骨疗法。我们的目的是测试普通轻触式整骨疗法对 "肠绞痛 "婴儿哭闹时间的有效性。方法 这是一项优越性、双臂、单盲(家长)多中心(英国、澳大利亚和瑞士)随机对照试验,研究对象包括 1 到 69 天大的健康婴儿,这些婴儿过度哭闹、烦躁不安或苦恼且难以安慰。试验干预包括常规的轻触式整骨疗法,对照干预则是对身体随机部位进行简单的轻触,没有治疗意图。两组均接受最佳实践建议和指导。主要结果是每天的哭闹时间,由家长每小时在日记中报告,为期两周。次要结果是育儿信心、总体变化、满意度和护理体验。结果共招募了 66 名婴儿(32 名试验组:34 名对照组)。测试组平均每天哭闹时间为 124 分钟(标准差 = 69,n = 26),对照组平均每天哭闹时间为 115 分钟(标准差 = 49,n = 29)。经调整后,测试组婴儿每天的哭闹时间比对照组多 2.2 分钟(CI95 % -20 至 25 分钟,P = 0.849)。两组家长对症状的总体变化、对护理的满意度和体验的感知均较高且相似。没有发生与治疗或试验相关的严重不良事件。可能需要重新考虑有关整骨疗法有意轻触护理机制的生物力学解释模型和基本假设。试验注册ACTRN12620000047998(2020年1月22日)。
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来源期刊
CiteScore
2.20
自引率
36.80%
发文量
42
审稿时长
3 months
期刊介绍: The International Journal of Osteopathic Medicine is a peer-reviewed journal that provides for the publication of high quality research articles and review papers that are as broad as the many disciplines that influence and underpin the principles and practice of osteopathic medicine. Particular emphasis is given to basic science research, clinical epidemiology and health social science in relation to osteopathy and neuromusculoskeletal medicine. The Editorial Board encourages submission of articles based on both quantitative and qualitative research designs. The Editorial Board also aims to provide a forum for discourse and debate on any aspect of osteopathy and neuromusculoskeletal medicine with the aim of critically evaluating existing practices in regard to the diagnosis, treatment and management of patients with neuromusculoskeletal disorders and somatic dysfunction. All manuscripts submitted to the IJOM are subject to a blinded review process. The categories currently available for publication include reports of original research, review papers, commentaries and articles related to clinical practice, including case reports. Further details can be found in the IJOM Instructions for Authors. Manuscripts are accepted for publication with the understanding that no substantial part has been, or will be published elsewhere.
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