NCT01761331

Brief Summary

The purpose of this prospective randomized three armed, multi center study is to compare the effect of two types of acupuncture and no acupuncture in 2-8 weeks old infants with infantile colic. Group A will get standardized minimal acupuncture in LI4, group B will get individualized acupuncture in different points according to symptoms and group C will not get acupuncture. Parents (who register the infants crying) and the nurse they meet at the study CHC are blinded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

2.3 years

First QC Date

December 29, 2012

Last Update Submit

June 25, 2016

Conditions

Infantile Colic

Keywords

infant, colic, crying, acupuncture, stooling, sleep

Outcome Measures

Primary Outcomes (1)

  • change in crying

    Difference over time and between groups in reduction in % of colicky crying, crying and fussing in minutes/day

    mean values for crying during the baseline week, during each of the two intervention weeks and during the week after the last treatment

Secondary Outcomes (1)

  • change in stooling

    mean values for stooling during the baseline week, during each of the two intervention weeks and during the week after the last treatment

Other Outcomes (3)

  • Change in hours of sleep

    mean values for sleep and length of undisturbed sleep during the baseline week, during each of the two intervention weeks and during the week after the last treatment

  • side effects

    each of the four visits to the study CHC and one week after the last visit

  • Blinding

    each of the four visits to the study CHC and one week after the last visit

Study Arms (3)

Group A: Standardized acupuncture

ACTIVE COMPARATOR

Infants come to the clinic twice a week for three weeks. Parents meet a nurse and hand the infant to her. The nurse brings the infant to a room where another nurse, trained in acupuncture, is alone with the infant for five minutes. Intervention: Infants in the standardized acupuncture group get minimal acupuncture: one needle is inserted about 3 mm in the point LI4 on the infants hands, unilaterally, for 2-10 seconds and then withdrawn.

Other: Acupuncture

Group B: Individualized acupuncture

ACTIVE COMPARATOR

Infants come to the clinic twice a week for three weeks. Parents meet a nurse and hand the infant to her. The nurse brings the infant to a room where another nurse, trained in acupuncture, is alone with the infant for five minutes. Infants in the individualized acupuncture group get acupuncture in points chosen by the acupuncturists according to symptoms: maximum 5 needles are inserted about 3 mm in points recommended in a guideline produced for the trial. Needles are retained for maximum one minute.

Other: Acupuncture

Group C: No acupuncture

NO INTERVENTION

Infants come to the clinic twice a week for three weeks. Parents meet a nurse and hand the infant to her. The nurse brings the infant to a room where another nurse, trained in acupuncture, is alone with the infant for five minutes. The nurse hold the infant´s hand and talks to it but no acupuncture is given.

Interventions

AcupunctureOTHER

Minimal standardized acupuncture: one needle is inserted about 3 mm in the point LI4 on the infants hands, unilaterally, for 2-10 seconds and then withdrawn. Individualized acupuncture: maximum 5 needles are inserted, about 3 mm deep, in points chosen by the acupuncturists according to symptoms, in points recommended in a guideline produced for the trial. Needles are retained for maximum one minute.

Group A: Standardized acupunctureGroup B: Individualized acupuncture

Eligibility Criteria

Age2 Weeks - 8 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • otherwise healthy infants
  • crying/fussing more than three hours/day more than three days in the same week
  • has tried cow´s milk protein free diet for at least five days

You may not qualify if:

  • born before week 36
  • has tried acupuncture treatment
  • dont gain weight properly
  • taking other medicine than dimethicone or lactobacillus reuteri
  • parents who don´t understand Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Arlöv vårdcentral, BVC

Arlöv, Skåne County, 232 38, Sweden

Location

Askims vårdcentral, BVC

Askim, Västra Götaland County, 436 32, Sweden

Location

Tullgårdens BVC

Karlskrona, 371 85, Sweden

Location

Valla Vårdcentral, BVC

Linköping, Östergötland County, 582 16, Sweden

Location

Related Publications (3)

  • Landgren K, Hallstrom I, Tiberg I. The effect of two types of minimal acupuncture on stooling, sleeping and feeding in infants with colic: secondary analysis of a multicentre RCT in Sweden (ACU-COL). Acupunct Med. 2021 Apr;39(2):106-115. doi: 10.1177/0964528420920308. Epub 2020 May 6.

    PMID: 32375501DERIVED

  • Landgren K, Hallstrom I. Effect of minimal acupuncture for infantile colic: a multicentre, three-armed, single-blind, randomised controlled trial (ACU-COL). Acupunct Med. 2017 Jun;35(3):171-179. doi: 10.1136/acupmed-2016-011208. Epub 2017 Jan 16.

    PMID: 28093383DERIVED

  • Landgren K, Tiberg I, Hallstrom I. Standardized minimal acupuncture, individualized acupuncture, and no acupuncture for infantile colic: study protocol for a multicenter randomized controlled trial - ACU-COL. BMC Complement Altern Med. 2015 Sep 14;15:325. doi: 10.1186/s12906-015-0850-x.

    PMID: 26370560DERIVED

MeSH Terms

Conditions

ColicCrying

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNonverbal CommunicationCommunicationBehavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Kajsa Landgren, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 29, 2012

First Posted

January 4, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 28, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(4)