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

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ClinicalTrials.gov Identifier: NCT00954759
Recruitment Status : Terminated (Abandoned due to poor recruitment)
First Posted : August 7, 2009
Last Update Posted : November 7, 2012
Sponsor:
Collaborators:
Foundation for the Advancement of Chiropractic Research
University of Southern Denmark
Information provided by:
Nordic Institute of Chiropractic and Clinical Biomechanics

Tracking Information
First Submitted Date  ICMJE August 6, 2009
First Posted Date  ICMJE August 7, 2009
Last Update Posted Date November 7, 2012
Study Start Date  ICMJE September 2009
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2009)
Decrease in hours of crying [ Time Frame: Two weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00954759 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Chiropractic Treatment on Infantile Colic A Randomized, Controlled Trial
Official Title  ICMJE The Effect of Chiropractic Treatment on Infantile Colic A Randomized, Controlled Trial
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.

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.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infantile Colic
Intervention  ICMJE
  • Procedure: Chiropractic treatment
    Other Name: Manipulation, mobilisation
  • 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.
Study Arms
  • Experimental: Chiropractic treatment
    Manipulation and/or mobilisation
    Intervention: Procedure: Chiropractic treatment
  • 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.
    Intervention: Procedure: Visit without active treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 6, 2012)
29
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2009)
200
Actual Study Completion Date August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 10 Weeks   (Child)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00954759
Other Study ID Numbers  ICMJE RCT Colic
CVK S-20090056
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lise Hestbaek, senior researcher, Nordic Institute of Chiropractic and Clinical Biomechanics
Study Sponsor  ICMJE Nordic Institute of Chiropractic and Clinical Biomechanics
Collaborators  ICMJE
  • Foundation for the Advancement of Chiropractic Research
  • University of Southern Denmark
Investigators  ICMJE
Study Director: Lise Hestbaek, PhD Nordic Institute of Chiropractic and Clinical Biomechanics
PRS Account Nordic Institute of Chiropractic and Clinical Biomechanics
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP