Acupuncture in Infantile Colic - a Three Armed Randomized Multi Center Trial (ACU-COL)

Infantile Colic Clinical Trial

— ACU-COL  

Official title:

Acupuncture in Infantile Colic - a Three Armed Randomized Multi Center Trial Comparing Acupuncture in a Standardized Point, Acupuncture in Individually Chosen Points and no Acupuncture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761331
• Other study ID #: LU-HSC-KL2013
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 29, 2012
• Last updated: June 25, 2016
• Start date: January 2013
• Est. completion date: May 2015

Study information

• Verified date: June 2016
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Infantile colic is a common problem, affecting 10-20% of newborns. Both the baby and the parents are suffering and there is a risk that the early relationship is disturbed. There is no safe and effective drug and the use of complementary medicine is increasing in spite of weak or no evidence. Acupuncture releases different neurotransmitters and hormones, is calming, gives pain reduction and affects digestion. Therefore it is reasonable that acupuncture can have effect in colic. Acupuncture in infantile colic has shown promising results in the few scientific trials conducted. These trials have evaluated the effect of standardized minimal acupuncture in the acupuncture points Large Intestine 4 (LI4) (two trials) or Stomach 36 (ST36) (one recent trial). In this prospective randomized three armed, multi center study performed at Child Health Centers in three towns, the effect of acupuncture in reducing symptoms in infants, 2-8 weeks old, with colic will be investigated. Two types of acupuncture: standardized minimal acupuncture in LI4 and individualized acupuncture in different points according to symptoms will be compared to an untreated group. Parents (who register the infants crying) and the nurse they meet at the study CHC are blinded.

Parents will get information about the trial from nurses and doctors at Child Health Centers (CHC) or from a web-site (www.spädbarnskolik.se). Parents who are interested in letting their infant participate in the trial get further information and sign informed consent. The trial is approved by the ethical board at Lund University.

Infant´s crying, fussing, sleep, feeding and stooling will be registered in a diary during a baseline week. Infants who cry/fuss more than three hours/day, more than three days during this week is included and randomized. Beside their ordinary contacts with their Child Health Center (CHC), infants and their parents are invited to visit a study CHC twice a week for two weeks, where they meet a nurse for about 20 minutes. Parents can describe their situation, discuss the infant´s symptoms and get advice. This nurse is blinded to which group the infant is randomized to. She carries the baby to another room and hands over the infant to a nurse, trained in acupuncture. The acupuncture nurse randomizes the infants to one of three groups, following a randomization list produced by the research department at Lund University Hospital. Group A will get standardized 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. Group B will get individualized 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 after discussions with experienced pediatric acupuncturists. Needles are retained for maximum one minute. Group C will not get acupuncture but will otherwise be treated similarly: they will be with the acupuncture nurse for five minutes while she holds the hand of the baby and talks to it in a calm voice. The acupuncture nurse make notes about bleeding and other possible side effects, and if the baby is crying. After approximately five minutes the acupuncture nurse calls the study nurse who carries the baby back to the parents. At every visit the study nurse asks parents if they have noticed any side effects, and asks if parents believe their baby gets acupuncture or not.

During the two intervention weeks and one week after the last visit to the study CHC parents register the infants behavior daily in a diary. Statistical analyses will be made from the diaries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 8 Weeks

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic
• Infantile Colic

Intervention

Other:
• Acupuncture
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.

Locations

Country	Name	City	State
Sweden	Arlöv vårdcentral, BVC	Arlöv	Skåne
Sweden	Askims vårdcentral, BVC	Askim	Västra Götaland
Sweden	Tullgårdens BVC	Karlskrona
Sweden	Valla Vårdcentral, BVC	Linköping	Östergötland

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Ekhagastiftelsen

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in hours of sleep	Hours of sleep per day	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	No
Other	side effects	At each visit parents will be asked by the study nurse whether they have noticed any side effects that they believe can be associated with acupuncture. One week after the last visit they will, by telephone, be asked the same question by the study coordinator.	each of the four visits to the study CHC and one week after the last visit	Yes
Other	Blinding	At each visit parents will be asked by the study nurse whether they believe that their infant is allocated to acupuncture or not. One week after the last visit they will, by telephone, be asked the same question by the study coordinator.	each of the four visits to the study CHC and one week after the last visit	No
Primary	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	No
Secondary	change in stooling	The frequency of stooling per day	mean values for stooling during the baseline week, during each of the two intervention weeks and during the week after the last treatment	No