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

This study has been terminated.
(Abandoned due to poor recruitment)
Sponsor:
Collaborators:
Foundation for the Advancement of Chiropractic Research
University of Southern Denmark
Information provided by:
Nordic Institute of Chiropractic and Clinical Biomechanics
ClinicalTrials.gov Identifier:
NCT00954759
First received: August 6, 2009
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Infantile Colic
Procedure: Chiropractic treatment
Procedure: Visit without active treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Chiropractic Treatment on Infantile Colic A Randomized, Controlled Trial

Further study details as provided by Nordic Institute of Chiropractic and Clinical Biomechanics:

Primary Outcome Measures:
  • Decrease in hours of crying [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: September 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chiropractic treatment
Manipulation and/or mobilisation
Procedure: Chiropractic treatment
Other Name: Manipulation, mobilisation
Placebo Comparator: 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.
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.

Detailed Description:

OBJECTIVES:

Primary: To investigate the effect of chiropractic treatment on infantile colic.

Secondary: A) To investigate if infants with suspected musculoskeletal problems respond differently to the treatment than those without. B) To investigate whether health visitors and chiropractors can agree on the diagnosis of "suspected musculoskeletal problems".

METHOD:

A randomized controlled single blind multicenter clinical trial with a nested case-crossover study.

Infants fulfilling the diagnostic criteria for colic will be recruited by health visitors and randomized to chiropractic treatment or no treatment. The parents will be unaware of the child's allocation. All children will be taken to the chiropractors' treatment room while the parents stay in the reception areas. Before treatment, both the recruiting health visitors and the chiropractors will note, whether they suspect musculoskeletal involvement or not. All analyses will be adjusted for known confounders, which will be recorded by the health visitor at baseline.

PERSPECTIVE FOR HEALTH CARE:

First of all, the study will evaluate the effect of chiropractic treatment of infantile colic. Secondly, it will clarify if the treatment effect differ between children with suspected musculoskeletal problems and those without. If children with musculoskeletal problems respond better to chiropractic treatment than others, the study will also indicate whether the health nurse is able to identify these children.

  Eligibility

Ages Eligible for Study:   up to 10 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion criteria:

  • Known disease.
  • Unsatisfying weight gain.
  • Psychological or developmental compromise.
  • Contraindications for chiropractic treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954759

Locations
Denmark
Nordic Institute of Chiropractic and Clinical Biomechanics
Odense, DK, Denmark, 5230
Sponsors and Collaborators
Nordic Institute of Chiropractic and Clinical Biomechanics
Foundation for the Advancement of Chiropractic Research
University of Southern Denmark
Investigators
Study Director: Lise Hestbaek, PhD Nordic Institute of Chiropractic and Clinical Biomechanics
  More Information

No publications provided

Responsible Party: Lise Hestbaek, senior researcher, Nordic Institute of Chiropractic and Clinical Biomechanics
ClinicalTrials.gov Identifier: NCT00954759     History of Changes
Other Study ID Numbers: RCT Colic, CVK S-20090056
Study First Received: August 6, 2009
Last Updated: November 6, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Nordic Institute of Chiropractic and Clinical Biomechanics:
Infantile colic
Chiropractic
Manipulation
Randomized controlled trial

Additional relevant MeSH terms:
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 20, 2014