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

Not Applicable

Completed

• Conditions: Colic, Infantile; Infant Conditions; Gastro-Intestinal Disorder
• Interventions: Other: Manual treatment

• Registration Number: NCT03675763
• Lead Sponsor: Universidad Católica San Antonio de Murcia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-02
• Primary Completion: 2016-12-20
• Study Completion: 2016-12-30
• Study First Submitted: 2018-09-15
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-18
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Craniosacral therapy	Manual treatment	Craniosacral therapy and parent information on how to manage colic.

Primary Outcome Measures

Name	Time	Method
Crying	Change from baseline crying at 24 days, also evaluated at days 7 and 14	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.

Secondary Outcome Measures

Name	Time	Method
Sleep	Change from baseline sleep at 24 days, also evaluated at days 7 and 14	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.
Severity-ICSQ	Change from baseline severity -ICSQ at 24 days, also evaluated at days 7 and 14	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.