Effects of Acupuncture in the Treatment of Infant Colic

Study Overview
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Brief Summary
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Standardized acupuncture treatment for infant colic is a common treatment in general practice for doctors educated in medical acupuncture. The investigators plan to study whether the perceived opinion on positive results can be verified in a multi-center clinical trial. The investigators aim to measure the effect of standardized acupuncture treatment, three repeated sessions, on infant colic in a randomized singe blinded prospective multi-center study, starting September 2009. The study will be done in thirteen locations in Norway by specialists in General Practice trained in acupuncture. The investigators intend to include a total of 130 patients, 65 in the intervention group and 65 in the control group.

Official Title
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Effects of Acupuncture in the Treatment of Infant Colic: A Prospective Multi-center Single Blinded Randomized Controlled Study

Conditions
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Infant Colic

Intervention / Treatment
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* Procedure: Acupuncture with Seirin 020x15 mm sterile acupuncture needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants under 3 months of age with birth weight over 2500 g and/or over 36th week of gestation. Further fulfilling Wessel et al criteria for infant colic: Paroxystic uncontrollable crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying per day for more than 3 days a week for more than 3 weeks. Exclusion Criteria: Infants over 3 months of age with birth weight under 2500 g and/or under 36th week of gestation. Not fulfilling Wessel et al criteria for infant colic: Paroxystic uncontrollable crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying pr.day for more than 3 days a week for more than 3 weeks.

Ages Eligible for Study
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Minimum Age: 3 Weeks
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Acupuncture with Seirin 020x15 mm sterile acupuncture needle: Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36 on infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition: Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks. | Procedure: Acupuncture with Seirin 020x15 mm sterile acupuncture needle<br>* Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36.<br>* Other names: Seirin 020x15mm sterile acupuncture needle;|
| No Intervention: Control<br>Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition: Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks. The Control group will have no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Crying Time Per 24 Hour Period. | Crying time per 24 hour period at baseline and post treatment | 6 time points measured: First, second and third intervention day, one day after last intervention, one week after last intervention and one month after last intervention. All time points measured in 24 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents Evaluation of Benefit to the Child. | Parents subjective assessment of the childs condition, on a 5 point scale, with 1 being worse and 5 being completely well. The numbers are the actual evaluations on the time specified. | 5 days, 1 , and 4 weeks after the first treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant Colic, Acupuncture, General Practice