The Effect of Chiropractic Treatment on Infantile Colic A Randomized, Controlled Trial

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.

Conditions

• Infantile Colic

Interventions

PROCEDURE

Chiropractic treatment

PROCEDURE

Visit without active treatment

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

Sponsors & Collaborators

• Foundation for the Advancement of Chiropractic Research

  collaborator UNKNOWN

• University of Southern Denmark

  collaborator OTHER

• Nordic Institute of Chiropractic and Clinical Biomechanics

  lead OTHER

Principal Investigators

• Lise Hestbaek, PhD · Nordic Institute of Chiropractic and Clinical Biomechanics

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

2 Weeks

Max Age

10 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2012-08-31

Completion

2012-08-31

Countries

• Denmark

Study Locations