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Published on: February 5, 2019
Osteopathic treatment of infants with infantile colic/excessive crying: a prospective, multicentric, randomized
Florian Schwerla1, Marlen Zimmer2, Janine Göpfert2
1German Academy of Osteopathy, Research Commission, Roemerschanzweg 5, Gauting, 82131, Germany. f.schwerla@german-afo.de.
Insights
Osteopathic treatments significantly reduced parental psychological stress in infants with colic. This intervention also improved crying intensity and duration, offering relief to caregivers.
Area of Science:
- Pediatrics
- Osteopathic Manipulative Medicine
- Evidence-Based Healthcare
Background:
- Infantile colic (IC/EC) is characterized by excessive crying in healthy infants, posing a significant challenge for caregivers.
- The exact causes of infantile colic remain poorly understood, leading to frustration for families.
- Osteopathic manipulative treatment is explored as a potential intervention for managing infantile colic.
Purpose of the Study:
- To evaluate the impact of osteopathic treatments on parental psychological stress in infants with colic.
- To compare the effectiveness of osteopathic treatment versus usual care for infantile colic.
- To assess secondary outcomes including crying time, intensity, and parental self-confidence.
Main Methods:
- A prospective, multicenter, randomized controlled trial was conducted.
- Infants aged 1 week to 3 months meeting Rome IV criteria for IC/EC were randomized.
- The intervention group received three osteopathic treatments, while the control group received usual care, with osteopathic treatment offered after a delay.
Main Results:
- A total of 103 infants were included in the study.
- Osteopathic treatment led to statistically significant and clinically relevant improvements in parental psychological stress.
- Secondary outcomes, including crying intensity and duration, also showed improvements comparable in magnitude to the primary outcome.
Conclusions:
- Three osteopathic treatments over two weeks effectively reduced parental psychological stress in infants with colic.
- Osteopathic manipulative treatment offers a beneficial therapeutic option for managing infantile colic and supporting caregivers.
- The study provides evidence for the positive impact of osteopathic care on infant well-being and family stress.
Background:
Colic in infants is defined as excessive crying in an otherwise healthy and thriving baby. Colic is a common but poorly understood and often frustrating problem for caregivers.
Objective:
To study whether osteopathic treatments of infants with infantile colic / excessive crying (IC/EC) have an impact on the subjectively perceived psychological stress of caregivers compared to usual care.
Methods:
The study was designed as a prospective, multicenter, randomized controlled trial. Infants aged 1 week to 3 months and who met Rome IV criteria for IC/EC were included. By means of external randomization, infants were allocated to an intervention group or a control group. Infants in the intervention group received three osteopathic treatments at intervals of one weeks. The treatments were custom-tailored and based on osteopathic principles. Controls received their osteopathic treatment after a 3 week untreated period. The primary outcome parameter was the assessment of parental psychological stress (three questions), measured using a numeric rating scale (NRS; 0-10). Furthermore, the average daily crying time (measured using the Likert scale), the crying intensity (measured using the NRS) and the parents' self-confidence (measured using the Karitane Parenting Confidence Scale) were assessed.
Results:
A total of 103 infants (average age 39.4 ±19.2 days) were included, 52 in the intervention group and 51 in the control group. An inter-group comparison of changes revealed clinically relevant improvements in favor of the intervention group for the main outcome - parameter psychological stress - for all 3 questions (e.g., for question 2 respectively 3, NRS: between group difference of means 3.5; 95% CI: 2.6 to 4.4; p < 0.001). For the secondary outcome parameters of crying intensity and crying time/day, the changes were of similar magnitude.
Conclusion:
Three osteopathic treatments given over a period of two weeks led to statistically significant and clinically relevant positive changes of parental psychological stress.
Trial Registration:
German Clinical Trials Register: DRKS00025867, registration date 10.08.21.
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