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

Abstract

BackgroundInfantile 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.MethodThe 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.DiscussionIn 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 registrationClinicaltrials.gov and Identifier: NCT02595515 (registered 2 November 2015).Electronic supplementary materialThe online version of this article (10.1186/s12998-018-0188-9) contains supplementary material, which is available to authorized users.

The global summit on the efficacy and effectiveness of spinal manipulative therapy for the prevention and treatment of non-musculoskeletal disorders: a systematic review of the literature

“…Therefore, future trials can potentially alter our findings and conclusions. For example, we are aware of one ongoing RCT on the effectiveness of manipulation/mobilization for the management of infantile colic [ 98 ]. Once published, the quality of this trial should be evaluated, and its results integrated in an updated review.…”

A modern view of medical accompaniment of the colic in neonate (literature review)

“…до 4-5 міс. по про фесійну медичну допомогу є незрозумілий три валий плач і неспокій дитини, що розцінюють ся батьками як прояв серйозного захворювання [7,9]. Нині першим консультантом батьків за звичай стає інтернет ресурс, з якого вони дізна ються не тільки про те, що причиною неспокою дитини можуть бути кольки, але й інші серйоз ні захворювання, які маніфестують у перший місяць життя дитини, -синдром мальабсорб ції, первинна лактазна недостатність, гастро езофагеальний рефлюкс, муковісцидоз, целіа кія.…”

“…Можливе застосування перорального гіпертонічного роз чину глюкози [6]. Популярні серед українських батьків відвари і настої лікарських трав (ромашка, кмин, фенхель, коріандр, насіння кропу, моркви), спазмолітичні і вітрогонні засоби, ферменти, механічні втручання: клізма, газовивідна трубка не характеризуються висо кою клінічною ефективністю, а отже, їх не можна призначати рутинно [7,9,16,18].…”

“…За результатами 3 рандомізованих контрольо ваних досліджень за участю 307 немовлят, вну трішньошкірна акупунктура не рекомендована для лікування кольок у немовлят [22]. Маніпу лятивна терапія кольок також немає належного обґрунтування через низку методологічних недоліків, що відображено в Кокрайнівському огляді 6 рандомізованих досліджень [9,22].…”

Identifying potential treatment effect modifiers of the effectiveness of chiropractic care to infants with colic through prespecified secondary analyses of a randomised controlled trial

“…The current study is based on data from a randomised controlled trial evaluating the effect of chiropractic care in Danish infants aged 2–14 weeks with excessive crying. The results are in the publication process, but details of the study design are described in the published study protocol [ 14 ]. The primary outcome was change in daily hours of crying during a two-week period from start of treatment.…”