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OpenTrials
Completed

NCT Number: NCT03675763

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

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.

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Key information

Conditions

Infant Conditions Colic Colic, Infantile Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Gastro-Intestinal Disorder Infant, Newborn, Diseases

Age range

0 day–90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual treatment

Other

Craniosacral therapy protocol.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 18, 2018
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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