Trial reportBMC pediatrics2025
Osteopathic treatment of infants with infantile colic/excessive crying: a prospective, multicentric, randomized controlled trial and nested observational trial.
Trial report in BMC pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
7 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundColic 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.
objectiveTo 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.
methodsThe 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.
resultsA 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.
conclusionThree osteopathic treatments given over a period of two weeks led to statistically significant and clinically relevant positive changes of parental psychological stress.
trial registrationGerman Clinical Trials Register: DRKS00025867, registration date 10.08.21.
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