NCT03675763

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2016

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

September 15, 2018

Last Update Submit

January 20, 2022

Conditions

Infant ConditionsColic, InfantileGastro-Intestinal Disorder

Keywords

SkullOsteopathic ManipulationInfantile ColicClinical TrialMassageInfantOsteopathic Medicine

Outcome Measures

Primary Outcomes (1)

  • Crying

    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 Outcomes (2)

  • Sleep

    Change from baseline sleep at 24 days, also evaluated at days 7 and 14

  • Severity-ICSQ

    Change from baseline severity -ICSQ at 24 days, also evaluated at days 7 and 14

Study Arms (2)

Craniosacral therapy

EXPERIMENTAL

Craniosacral therapy and parent information on how to manage colic.

Other: Manual treatment

Parent information

NO INTERVENTION

Parent information on how to manage colic.

Interventions

Manual treatmentOTHER

Craniosacral therapy protocol.

Craniosacral therapy

Eligibility Criteria

Age0 Days - 90 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • infants diagnosed with any sort of pathological illness, allergies or food intolerance
  • who have suffered any intracranial hemorrhages or skull fractures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ColicDigestive System Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Osteopath

Study Record Dates

First Submitted

September 15, 2018

First Posted

September 18, 2018

Study Start

March 2, 2015

Primary Completion

December 20, 2016

Study Completion

December 30, 2016

Last Updated

February 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share