NCT04841590

Effects of Osteopathic Manual Therapy on Infant Colic

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Seville · Academic / Other
• Sex: All
• Age: 2 Weeks – 12 Weeks
• Healthy volunteers: Not accepted

Summary

Infant colic (CL) is a common disorder that affects approximately 8-33% of newborns during the first months of life. Typically defined as "crying that lasts at least 3 hours a day, and occurs at least 3 days a week over a 3-week period." Osteopathic manual therapy is presented as an effective and safe alternative to CL treatment. The main objective of the study is to quantify possible changes in daily crying hours and hours of sleep, the severity of CL, the frequency of episodes, changes in stool and possible adverse effects. The study hypothesis argues that the application of osteopathic manual therapy in babies with CL produces an improvement in the hours of daily crying, the frequency of episodes, the severity of colic and the hours of sleep. A controlled RCT will be performed where the evaluator and the parents will be blinded with respect to the allocation group for each subject. Subjects who meet the inclusion and exclusion criteria will be randomly assigned to the experimental group (EG) and control group (CG) using a table of random numbers by a person from outside the research. The EG diagnosis treatment using techniques of osteopathic manual therapy, vertebral mobilization, cranial techniques and visceral mobilization, according to the diagnostic criteria of the therapist. The CG has no treatment. A total of 3 procedures were performed, one per week, problems with the chronology in all groups (days 0, 7 and 14 if required). The therapist in charge of performing the operations will be a Physiotherapist and Osteopath with more than 10 years of experience. The evaluations will be carried out by a healthcare professional with more than 10 years of experience. The evaluator will be blinded. Parents blinded with respect to the allocation group of each subject until the end of the study. To analyze the main variable of the study (total hours of excessive crying per day), use the crying diary completed by the parents. The Infantile Colic Severity Questionnaire (ICSQ) will be applied to evaluate the secondary variables (sleep, feces, frequency of episodes and severity of colic).

Conditions

• Colic, Infantile

Interventions

Type	Name	Description
OTHER	Intervention of the experimental group (EG)	Treatment through the use of manual physiotherapy techniques such as mobilization techniques in the spinal column, cranial techniques and visceral mobilization applied by gentle pressure, according to the therapist's diagnostic criteria after performing palpatory and mobility tests.
OTHER	Control Group (CG)	Subjects in the control group (CG) will not receive any treatment

Timeline

• Start date: 2021-04-01
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2021-04-12
• Last updated: 2025-06-11

Locations

3 sites across 1 country: Spain