Effects of Acupuncture in the Treatment of Infant Colic

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.

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Key information

Conditions

Infant Colic Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases

Age range

3 week–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute of Primary Care and Community Health, Faculty of Medicine, University of Oslo.

Oslo, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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."

Treatment and study plan

Acupuncture with Seirin 020x15 mm sterile acupuncture needle

Procedure

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.

Other names: Seirin 020x15mm sterile acupuncture needle

Primary outcomes

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.

Crying time per 24 hour period at baseline and post treatment

Secondary outcomes

Parents Evaluation of Benefit to the Child.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: May 22, 2009
Registry last updated: Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed