NCT Number: NCT04841590
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).
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Notify Me2 week–12 week
All sexes
Interventional
Not applicable
Clinica de Fisioterapia y Osteopatía M4, Granada, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Subjects in the control group (CG) will not receive any treatment
Time frame: At the beginning of the study (pre-intervention)
A crying diary completed by the parents will be used to compute the total hours per day that the subject presents crying.
Time frame: 1 week after the first intervention
A crying diary completed by the parents will be used to compute the total hours per day that the subject presents crying.
Time frame: 2 weeks after the first intervention
A crying diary completed by the parents will be used to compute the total hours per day that the subject presents crying.
Time frame: 3 weeks after the first intervention
A crying diary completed by the parents will be used to compute the total hours per day that the subject presents crying.
Time frame: Finally at 4 weeks from the first intervention
A crying diary completed by the parents will be used to compute the total hours per day that the subject presents crying.
Time frame: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
The total number of crying episodes per day will be assessed using the Crying Diary completed by the parents.
Time frame: 1 week after the first intervention
The total number of crying episodes per day will be assessed using the Crying Diary completed by the parents.
Time frame: 2 weeks after the first intervention
The total number of crying episodes per day will be assessed using the Crying Diary completed by the parents.
Time frame: 3 weeks after the first intervention
The total number of crying episodes per day will be assessed using the Crying Diary completed by the parents.
Time frame: Finally at 4 weeks from the first intervention
The total number of crying episodes per day will be assessed using the Crying Diary completed by the parents.
Time frame: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
Severity will be assessed using the Infantile Colic Severity Questionnaire (ICSQ), a reliable and validated questionnaire for the diagnosis and evaluation of infant colic.
The numerical values assigned to the responses suppose a score for each item that varies between 1-4 points, where 1 indicates "less seriousness" and 4 "more serious". The total score of the questionnaire is obtained by adding the value achieved in each item, which can range from 24 to 100 points.
Time frame: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
The total number of hours of sleep will be measured using the Infantile Colic Severity Questionnaire (ICSQ)
Time frame: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
Possible changes regarding this variable will be evaluated using the Infantile Colic Severity Questionnaire (ICSQ), a reliable and validated questionnaire for the diagnosis and evaluation of infant colic.
The numerical values assigned to the responses suppose a score for each item that varies between 1-4 points, where 1 indicates "less seriousness" and 4 "more serious". The total score of the questionnaire is obtained by adding the value achieved in each item, which can range from 24 to 100 points.
Time frame: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
It will be evaluated if the subjects take drugs at the beginning of the study, as well as the possible changes regarding this variable during the course of the study, using the Crying Diary completed by the parents.
University of Seville
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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