NCT00954759

Brief Summary

Infantile colic is a condition that affects more than 10% of babies and their families. The reason, and hence the proper treatment, for this condition is unknown and many causes have been suggested. One of the treatments that parents choose is chiropractic manipulation. In Denmark, around 4,000 babies are treated for colic by chiropractors each year although the effect of chiropractic treatment of infantile colic has not been properly scientifically evaluated. The effect of chiropractic treatment on infantile colic needs to be investigated since this is a very common disorder with no known effective treatment but with good empirical evidence of the value of chiropractic treatment. Although it is usually considered to be a benign and self-limiting condition, some studies suggest there might be long-term effects in terms of psychomotor problems. In worst case, the infants' crying may also lead to violence and 'shaken baby syndrome'. Null hypothesis: There is no effect of chiropractic treatment on the course of infantile colic. This study is a controlled clinical trial, where infants fulfilling the diagnostic criteria for colic will be randomized into two groups. One group will receive treatment and the other won't. This will determine the overall effect and furthermore, subgroup analyses will be performed to identify possible subgroups of infants who will benefit the most from the treatment. The results from subgroup analyses can help to identify children who might benefit from the treatment. Then treatment can be initiated early and a lot of hardship can be avoided for both the babies and the families.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

August 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

November 7, 2012

Status Verified

November 1, 2012

Enrollment Period

2.9 years

First QC Date

August 6, 2009

Last Update Submit

November 6, 2012

Conditions

Infantile Colic

Keywords

Infantile colicChiropracticManipulationRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Decrease in hours of crying

    Two weeks

Study Arms (2)

Chiropractic treatment

EXPERIMENTAL

Manipulation and/or mobilisation

Procedure: Chiropractic treatment

Visit without active treatment

PLACEBO COMPARATOR

The child is brought in for chiropractic treatment, but no active treatment is delivered. The parents are unaware whether treatment is delivered or not.

Procedure: Visit without active treatment

Interventions

Chiropractic treatmentPROCEDURE
Also known as: Manipulation, mobilisation
Chiropractic treatment
Visit without active treatmentPROCEDURE

The child is brought in for chiropractic treatment, but no active treatment is delivered. The parents are unaware whether treatment is delivered or not.

Visit without active treatment

Eligibility Criteria

Age2 Weeks - 10 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age: 2-10 weeks.
  • Minimum crying and fussing: three hours per day, three days per week.

You may not qualify if:

  • Known disease.
  • Unsatisfying weight gain.
  • Psychological or developmental compromise.
  • Contraindications for chiropractic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordic Institute of Chiropractic and Clinical Biomechanics

Odense, DK, 5230, Denmark

Location

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lise Hestbaek, PhD

    Nordic Institute of Chiropractic and Clinical Biomechanics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2009

First Posted

August 7, 2009

Study Start

September 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

November 7, 2012

Record last verified: 2012-11

Locations

DK(1)