Efficacy of a Craniosacral Therapy Protocol in the Treatment of Infant Colic

Gastro-Intestinal Disorder Clinical Trial

Official title:

Efficacy of a Craniosacral Therapy Protocol in the Treatment of Infant Colic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03675763
• Other study ID #: 77712133D
• Status: Completed
• Phase: N/A
• Start date: March 2, 2015
• Est. completion date: December 30, 2016

Study information

• Verified date: January 2022
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomised controlled trial that aims to determine the effectiveness of craniosacral therapy for the treatment of infantile colic. Manual therapy was applied to a group of young infants diagnosed with colic while a second group did not received any treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 30, 2016
• Est. primary completion date: December 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Days

Eligibility

Inclusion criteria:

• infants diagnosed with colic,

• with 0-90 days of age,

• who have had 3 hours of unexplainable crying per day for at least 3 days during the week previous to the study.

Exclusion criteria:

• infants diagnosed with any sort of pathological illness, allergies or food intolerance

• who have suffered any intracranial hemorrhages or skull fractures.

Related Conditions & MeSH terms

• Colic
• Colic, Infantile
• Digestive System Diseases
• Gastro-Intestinal Disorder
• Gastrointestinal Diseases
• Infant Conditions
• Intestinal Diseases

Intervention

Other:
• Manual treatment
Craniosacral therapy protocol.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crying	Total amount of time the infant cries within a day. Crying is recorded by the parents in a diary. The higher the score is, the more hours of crying per day.	Change from baseline crying at 24 days, also evaluated at days 7 and 14
Secondary	Sleep	Total amount of time the infant sleeps within a day. Sleep is recorded by the parents in a diary. The higher the score is, the more hours of sleep per day.	Change from baseline sleep at 24 days, also evaluated at days 7 and 14
Secondary	Severity-ICSQ	Severity of colic is measured according to a validated Infant Colic Severity Questionnaire. Minimum score is 24 and maximum 100. A score higher than 50 points suggests that the patient suffers from infantile colic.	Change from baseline severity -ICSQ at 24 days, also evaluated at days 7 and 14