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

NCT ID: NCT03675763

Last Updated: 2022-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-02

Study Completion Date

2016-12-30

Brief Summary

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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

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Conditions

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Infant Conditions Colic, Infantile Gastro-Intestinal Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Craniosacral therapy

Craniosacral therapy and parent information on how to manage colic.

Group Type EXPERIMENTAL

Manual treatment

Intervention Type OTHER

Craniosacral therapy protocol.

Parent information

Parent information on how to manage colic.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Manual treatment

Craniosacral therapy protocol.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

0 Days

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Mercedes Castejón Castejón

Osteopath

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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77712133D

Identifier Type: -

Identifier Source: org_study_id

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