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

January 20, 2022 updated by: Mercedes Castejón Castejón, Universidad Católica San Antonio de Murcia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Craniosacral therapy
Craniosacral therapy and parent information on how to manage colic.
Other: Manual treatment
Craniosacral therapy protocol.
No Intervention: Parent information
Parent information on how to manage colic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crying
Time Frame: 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.
Change from baseline crying at 24 days, also evaluated at days 7 and 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep
Time Frame: 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.
Change from baseline sleep at 24 days, also evaluated at days 7 and 14
Severity-ICSQ
Time Frame: 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.
Change from baseline severity -ICSQ at 24 days, also evaluated at days 7 and 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Católica San Antonio de Murcia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2015

Primary Completion (Actual)

December 20, 2016

Study Completion (Actual)

December 30, 2016

Study Registration Dates

First Submitted

September 15, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 77712133D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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