NCT01513304

Brief Summary

Efficacy of chiropractic manual therapy in infants with excessive crying behaviour. Influence of parental bias in reporting crying behaviour.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

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

September 1, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
Last Updated

January 20, 2012

Status Verified

January 1, 2012

Enrollment Period

3.7 years

First QC Date

January 17, 2012

Last Update Submit

January 19, 2012

Conditions

Infantile Colic

Outcome Measures

Primary Outcomes (1)

  • Daily crying diary

Study Arms (1)

Chiropractic manual therapy

EXPERIMENTAL
Procedure: Manual therapy

Interventions

Manual therapyPROCEDURE
Chiropractic manual therapy

Eligibility Criteria

AgeUp to 8 Weeks
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Excessive crying,
  • infant less than 8weeks of age,
  • born at gestational age 37 weeks or later, otherwise healthy

You may not qualify if:

  • Not accepted for chiropractic care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AECC

Bournemouth, Dorset, BH5 2DF, United Kingdom

Location

MeSH Terms

Conditions

Colic

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

January 17, 2012

First Posted

January 20, 2012

Study Start

September 1, 2007

Primary Completion

May 1, 2011

Last Updated

January 20, 2012

Record last verified: 2012-01

Locations

GB(1)