The Effect of Chiropractic Treatment on Infantile Colic A Randomized, Controlled Trial
NCT ID: NCT00954759
Last Updated: 2012-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
29 participants
INTERVENTIONAL
2009-09-30
2012-08-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Chiropractic treatment
Manipulation and/or mobilisation
Chiropractic treatment
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.
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.
Interventions
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Chiropractic treatment
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Minimum crying and fussing: three hours per day, three days per week.
Exclusion Criteria
* Unsatisfying weight gain.
* Psychological or developmental compromise.
* Contraindications for chiropractic treatment.
2 Weeks
10 Weeks
ALL
No
Sponsors
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Foundation for the Advancement of Chiropractic Research
UNKNOWN
University of Southern Denmark
OTHER
Nordic Institute of Chiropractic and Clinical Biomechanics
OTHER
Responsible Party
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Nordic Institute of Chiropractic and Clinical Biomechanics
Principal Investigators
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Lise Hestbaek, PhD
Role: STUDY_DIRECTOR
Nordic Institute of Chiropractic and Clinical Biomechanics
Locations
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Nordic Institute of Chiropractic and Clinical Biomechanics
Odense, DK, Denmark
Countries
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Other Identifiers
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CVK S-20090056
Identifier Type: -
Identifier Source: secondary_id
RCT Colic
Identifier Type: -
Identifier Source: org_study_id