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The effect of chiropractic treatment on infantile colic: study protocol for a single-blind randomized controlled trial

BACKGROUND: 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...

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Autores principales: Holm, Lise Vilstrup, Jarbøl, Dorte Ejg, Christensen, Henrik Wulff, Søndergaard, Jens, Hestbæk, Lise
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5991429/
https://www.ncbi.nlm.nih.gov/pubmed/29930798
http://dx.doi.org/10.1186/s12998-018-0188-9
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author Holm, Lise Vilstrup
Jarbøl, Dorte Ejg
Christensen, Henrik Wulff
Søndergaard, Jens
Hestbæk, Lise
author_facet Holm, Lise Vilstrup
Jarbøl, Dorte Ejg
Christensen, Henrik Wulff
Søndergaard, Jens
Hestbæk, Lise
author_sort Holm, Lise Vilstrup
collection PubMed
description BACKGROUND: 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. METHOD: 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. DISCUSSION: 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. TRIAL REGISTRATION: Clinicaltrials.gov and Identifier: NCT02595515 (registered 2 November 2015). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12998-018-0188-9) contains supplementary material, which is available to authorized users.
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spelling pubmed-59914292018-06-21 The effect of chiropractic treatment on infantile colic: study protocol for a single-blind randomized controlled trial Holm, Lise Vilstrup Jarbøl, Dorte Ejg Christensen, Henrik Wulff Søndergaard, Jens Hestbæk, Lise Chiropr Man Therap Study Protocol BACKGROUND: 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. METHOD: 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. DISCUSSION: 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. TRIAL REGISTRATION: Clinicaltrials.gov and Identifier: NCT02595515 (registered 2 November 2015). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12998-018-0188-9) contains supplementary material, which is available to authorized users. BioMed Central 2018-06-07 /pmc/articles/PMC5991429/ /pubmed/29930798 http://dx.doi.org/10.1186/s12998-018-0188-9 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Holm, Lise Vilstrup
Jarbøl, Dorte Ejg
Christensen, Henrik Wulff
Søndergaard, Jens
Hestbæk, Lise
The effect of chiropractic treatment on infantile colic: study protocol for a single-blind randomized controlled trial
title The effect of chiropractic treatment on infantile colic: study protocol for a single-blind randomized controlled trial
title_full The effect of chiropractic treatment on infantile colic: study protocol for a single-blind randomized controlled trial
title_fullStr The effect of chiropractic treatment on infantile colic: study protocol for a single-blind randomized controlled trial
title_full_unstemmed The effect of chiropractic treatment on infantile colic: study protocol for a single-blind randomized controlled trial
title_short The effect of chiropractic treatment on infantile colic: study protocol for a single-blind randomized controlled trial
title_sort effect of chiropractic treatment on infantile colic: study protocol for a single-blind randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5991429/
https://www.ncbi.nlm.nih.gov/pubmed/29930798
http://dx.doi.org/10.1186/s12998-018-0188-9
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