Acupuncture in Infantile Colic - A Randomised Trial.

Acupuncture Clinical Trial

Official title:

Acupuncture in Infantile Colic - A Randomised Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05894798
• Other study ID #: 230524
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 2027

Study information

• Verified date: June 2023
• Source: Region Skane
• Contact: Veronica Milos Nymberg, Ass. Prof.
• Phone: +46 (0)733565679
• Email: veronica.milos_nymberg[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Among all newborn babies in Sweden, about 10% have infant colic. Currently, there is no effective and safe treatment for infant colic, while there is an increase in the use of complementary methods to reduce the infant's suffering. Infant colic is defined as "crying and whining more than three hours/day more than three days/week" and affects about 10% of all newborn babies, starting when the baby is about two weeks old and usually stopping at 3-4 months of age. A complementary method used against pain in the Western world is acupuncture, a treatment method with ancient roots in Asia. It involves thin needles being inserted at specific points on the body. The needle sticks stimulate neurotransmitters, and hormones are released in the central nervous system. Acupuncture is an environmentally friendly treatment with few side effects and promotes the inherent ability to self-heal. Acupuncture has been shown in several studies to be a safe and effective method that affects pain, anxiety, sleep, and the function of the gastrointestinal system. Studies have shown both shorter crying time with lower intensity. Therefore, there is a reasonableness in acupuncture being able to alleviate infant colic. However, systematic reviews have not been able to show significant differences in symptoms between children who received acupuncture and those who did not. The reviews also described that the studies used different points on the body for treatment and that the acupuncture needles remained for various lengths of time (5-30 seconds). This led to their conclusion that more high-quality randomised studies are needed to investigate the treatment method further. Purpose To examine the effect of minimal acupuncture at a single point (LI4) on infants with colic compared to no acupuncture. Method: The parents register the baby's crying, feeding, sleep and bowel movements in a diary (appendix 1) for seven consecutive days, constituting a baseline. According to the diary registration, the infants who have colic are included and come twice a week for three weeks to a nurse at a selected child health centre (BVC). The children will be randomised into two groups; acupuncture at LI4 or no acupuncture. The parents will not know which group the child belongs to. The parents will fill in the same diary type as the baseline during the two intervention weeks. 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. This registration will also be done in the control group, where the handling of children is the same but without acupuncture. Expected result This study can provide further evidence on whether acupuncture is an effective treatment method for alleviating symptoms of infant colic, as well as further highlighting any experience of pain associated with treatment. The attitude towards complementary approaches among parents with infants showing colic symptoms will also be investigated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Weeks to 9 Weeks

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acupuncture
• Colic
• Colic, Infantile
• Infant, Newborn, Diseases

Intervention

Other:
• Acupuncture
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

Locations

Country	Name	City	State
Sweden	Laröd Health care Center	Helsingborg	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crying and screaming	Registration of crying and screaming during the acupuncture at each visit	During acupuncture
Primary	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

External Links

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