Clinical Trial: Effects of Acupuncture in the Treatment of Infant Colic

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: University of Oslo

Current Primary Outcome: Change in Crying Time Per 24 Hour Period. [ Time Frame: 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. ]

Original Primary Outcome: Reduction in time of crying per 24 hour period. Clinical relevance is defined by 1 hour reduction per 24 hour. [ Time Frame: 1 and 4 weeks after the first treatment ]

Current Secondary Outcome: Parents Evaluation of Benefit to the Child. [ Time Frame: 5 days, 1 , and 4 weeks after the first treatment ]

Original Secondary Outcome: Parents Evaluation of Benefit to the Child. [ Time Frame: 1 and 4 weeks after the first treatment ]

Information By: University of Oslo

Dates:
Date Received: May 21, 2009
Date Started: September 2009
Date Completion:
Last Updated: March 15, 2015
Last Verified: March 2015