Effects of Acupuncture in the Treatment of Infant Colic

NCT ID: NCT00907621

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-12-31

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.

Conditions

Infant Colic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acupuncture

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.

Group Type: EXPERIMENTAL

Acupuncture with Seirin 020x15 mm sterile acupuncture needle

Intervention Type: 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.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Seirin 020x15mm sterile acupuncture needle

Eligibility Criteria

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."

• Minimum Eligible Age: 3 Weeks
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Arne Fetveit

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Holgeir Skjeie, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Oslo, , Norway

Countries

Norway

References

Skjeie H, Skonnord T, Fetveit A, Brekke M. Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice. Scand J Prim Health Care. 2013 Dec;31(4):190-6. doi: 10.3109/02813432.2013.862915. Epub 2013 Nov 15.

Reference Type: RESULT

PMID: 24228748 (View on PubMed)

Skjeie H, Skonnord T, Fetveit A, Brekke M. A pilot study of ST36 acupuncture for infantile colic. Acupunct Med. 2011 Jun;29(2):103-7. doi: 10.1136/aim.2010.003590. Epub 2011 Mar 29.

Reference Type: DERIVED

PMID: 21450707 (View on PubMed)

Other Identifiers

infant colic

Identifier Type: -

Identifier Source: org_study_id