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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03675763

Enrollment

Registered

2018-09-18

Start date

2015-03-02

Completion date

2016-12-30

Last updated

2022-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colic, Infantile, Gastro-Intestinal Disorder, Infant Conditions

Keywords

Skull, Osteopathic Manipulation, Infantile Colic, Clinical Trial, Massage, Infant, Osteopathic Medicine

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.

Interventions

OTHERManual treatment

Craniosacral therapy protocol.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

0 Days to 90 Days

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026