Acupuncture in Infantile Colic - A Randomised Trial.

NCT05894798 | Withdrawn

• 1 other identifier: 230524
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

About 10 per cent of all new born babies in Sweden have infant colic. This may affect the the whole family and the early connection between the baby and the parents. Although, there are no effective and safe treatment. Acupuncture is an environmental friendly method that affects pain, anxiety, sleep and the function of gastrointestinal system. Several studies have shown various results, and there are a need for high-qualitative randomised controlled trials to investigate the proposed effect further. 128 children will be randomised into two groups; acupuncture at LI4 or no acupuncture, parents will be blinded. Statistical calculations will be performed on the content of the diaries (bowel movement frequency, crying time, feeding). Registration of crying/crying in connection with acupuncture treatment, i.e. when the needle touches the skin or later until the needle is removed and 30 seconds after.

Conditions

Infant, Newborn, Diseases; Colic, Infantile; Acupuncture

Keywords

Infant colic; pain; primary healthcare; gastrointestinal

Outcome Measures

Primary Outcomes (2)

• Crying and screaming

  Registration of crying and screaming during the acupuncture at each visit

  During acupuncture

• Colic symptoms

  Change in colic symptoms during the treatment period, comparison between groups. information will be collected by the diaries the parents write during the intervention period

  Baseline to 3 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The acupuncture nurse holds the child by the hand and speaks to it calmly for about a minute. The children receive acupuncture at point LI 4 in the grip of the thumb on the upper side of the hand, bilaterally, with a sterile disposable needle with dimensions 0.20 x 13 mm. The stitch is approximately three mm deep. The needle is allowed to remain in place for about 30 seconds

Other: Acupuncture

Controll

NO INTERVENTION

The children in the control group do not receive acupuncture. However, they spend the same amount of time with the acupuncture nurse, are addressed and are touched in the same way as the children in the intervention group, but do not get stung.

Interventions

Acupuncture OTHER

Acupuncture at point LI 4 in the thumb grip on the upper side of the hand, bilaterally, with a sterile disposable needle of dimension 0.20 x 13 mm. The stitch is approximately three mm deep. The needle is allowed to remain in place for about 30 seconds

Intervention

Eligibility Criteria

• Age: 2 Weeks - 9 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Otherwise healthy infants, born in week 37 or later, aged 2 - 9 weeks who, according to diary entries, scream/whine for at least 3 hours/day for at least 3 days in the same week. The child has undergone a medical examination at BB or later with no pathological findings. The child takes no medicines or only the dietary supplement Semper Magdroppar. At least one parent understands and speaks Swedish.

You may not qualify if:

• Children who have lost more than one channel on their weight curve. Children who received acupuncture

Sponsors & Collaborators

• Region Skane: lead

Related Publications (39)

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Related Links

• SBU - Swedish Agency for Health Technology Assessment and Assessment of Social Services. Does acupuncture relieve colic? (in Swedish)
• Rikshandboken i barnhälsovård (in Swedish; The national handbook in child health care)

MeSH Terms

Conditions

Infant, Newborn, Diseases; Colic; Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Veronica Milos Nymberg

  Lund University/ Region Skane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 8, 2023
• Study Start (Estimated): December 1, 2050
• Primary Completion (Estimated): December 1, 2060
• Study Completion (Estimated): December 1, 2060
• Last Updated: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share