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The effect of chiropractic treatment on infantile colic: study protocol for a single-blind randomized controlled
Lise Vilstrup Holm1,2, Dorte Ejg Jarbøl2, Henrik Wulff Christensen1
11Nordic Institute of Chiropractic and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, DK-5230 Odense M, Denmark.
Insights
This study investigated chiropractic care for infantile colic, a common condition in newborns. The pilot results indicate that chiropractic treatment is an acceptable and feasible option for infants experiencing excessive crying.
Area of Science:
- Pediatrics
- Chiropractic Medicine
- Evidence-Based Healthcare
Background:
- Infantile colic affects approximately 1 in 6 newborns, characterized by prolonged, inconsolable crying.
- The exact cause of infantile colic remains unknown, leading to diverse treatment investigations.
- Chiropractic care is increasingly utilized for infant conditions, including colic, despite limited supporting evidence.
Purpose of the Study:
- To evaluate the effectiveness of chiropractic treatment for infantile colic using a randomized controlled trial.
- To assess the acceptability and feasibility of chiropractic intervention in infants with colic through a pilot study.
- To explore potential benefits of chiropractic care for specific subgroups of infants with suspected musculoskeletal issues.
Main Methods:
- A single-blind randomized controlled trial design was employed.
- Participants were infants aged 2-14 weeks with unexplained excessive crying, recruited from the Island of Funen.
- Children were randomized to receive either chiropractic treatment or serve as a control, with outcomes measured by changes in daily crying duration.
Main Results:
- The pilot study demonstrated that the chiropractic intervention was acceptable and feasible for families with newborns.
- Detailed results on the effectiveness of chiropractic treatment on infantile colic are pending the full study completion.
Conclusions:
- Chiropractic treatment presents a potentially viable option for managing infantile colic.
- Further research is warranted to establish the efficacy of chiropractic care and identify potential responders.
- The findings support the need for stratified care approaches in managing infantile colic.
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).
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