Effects of Acupuncture in the Treatment of Infant Colic

Phase 2

Completed

Interventions: Procedure: Acupuncture with Seirin 020x15 mm sterile acupuncture needle

Brief Summary: 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.

Recruitment & Eligibility

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."

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture with Seirin 020x15 mm sterile acupuncture needle	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.

Primary Outcome Measures

Name	Time	Method
Change in Crying Time Per 24 Hour Period.	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.	Crying time per 24 hour period at baseline and post treatment

Secondary Outcome Measures

Name	Time	Method
Parents Evaluation of Benefit to the Child.	5 days, 1 , and 4 weeks after the first treatment	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.