An interventional study of Intervention of the experimental group (EG) and Control Group (CG) in Colic, Infantile, sponsored by University of Seville. Completed at 3 sites in Spain. Open to participants aged 2 Weeks to 12 Weeks. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by University of Seville · Not applicable, Interventional, and Treatment
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).
127 studies on the registry are indexed under Colic; 18 are open to participants now.
This study's enrollment of 50 is below the median of 76 across 110 interventional studies indexed under Colic.
Browse Colic studies →University of Seville is the lead sponsor of 130 studies on the registry; 39 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental group (EG) will receive 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: Intervention of the experimental group (EG)
The control group (CG) will not receive any treatment
Other: Control Group (CG)
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
Total hours of crying per day
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)
Total hours of crying per day
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
Total hours of crying per day
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
Total hours of crying per day
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
Total hours of crying per day
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
Frequency of episodes
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
Frequency of episodes
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
Frequency of episodes
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
Frequency of episodes
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
Frequency of episodes
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
Colic Severity
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
Hours of sleep
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
Stool
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
Use of drugs
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.
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
Plan to share: No
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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