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A pilot study of ST36 acupuncture for infantile colic
Holgeir Skjeie1, Trygve Skonnord, Arne Fetveit
1Department of General Practice/Family Medicine, Institute of Health and Society, University of Oslo, Oslo, Norway. h-skjeie@frisurf.no
Insights
This pilot study refined an acupuncture trial for infantile colic. Key changes included improving blinding validation for parents, essential for accurate symptom assessment in infants.
Area of Science:
- Pediatrics
- Integrative Medicine
- Clinical Trial Design
Background:
- Infantile colic significantly impacts infant well-being and parental stress.
- Acupuncture presents a potential non-pharmacological treatment option for infantile colic.
- Standardized trial protocols are crucial for evaluating acupuncture's efficacy.
Purpose of the Study:
- To assess the feasibility of a proposed acupuncture trial design for infantile colic.
- To refine intervention and blinding procedures for a main trial.
Main Methods:
- An open, randomized, single-blinded controlled pilot trial.
- Infants with colic received standardized acupuncture at the ST36 point or no treatment.
- Parents and assistants were blinded; blinding validation questions were used.
Main Results:
- The pilot study identified necessary improvements in standardization and blinding procedures.
- Blinding validation questions were deemed essential for accurate assessment.
- Adjustments were made to the main study protocol based on pilot findings.
Conclusions:
- Pilot studies are vital for optimizing clinical trial protocols, especially in pediatric populations.
- Effective blinding validation is critical in no-treatment controlled acupuncture trials involving parental assessment.
- Reporting blinding validation methods and results enhances trial transparency and reliability.
Objective:
To conduct a pilot study to assess the feasibility of a proposed design of an acupuncture trial to relieve symptoms of infantile colic.
Method:
An open randomised single-blinded controlled trial, using standardised bilateral treatment of the acupuncture point ST36. Infants fulfilling Wessel's definition of infantile colic were included.
Patients:
were randomised to active treatment or to no-treatment control. General practitioners (GPs) educated in Western medical acupuncture did the interventions. Parents and GPs' assistants were blinded. Active treatment was the bilateral insertion of 0.20×15 mm Seirin needles to 12 mm depth at ST36. The intervention consisted of daily treatments of 30 s duration for three consecutive workdays. Blinding was done with a red point mark on the skin and circular adhesive dressing covering. The parents were asked two blinding validation questions in the course of the study period. The primary end point was the effect of the intervention assessed as change in crying time per 24 h measured with a crying registration form.
Results:
The authors improved the standardisation and changed the blinding procedure as a result of the pilot study. Blinding validation questions were considered necessary. The changes made in the main study protocol are discussed.
Conclusion:
The pilot study led to important changes that were implemented into the final trial protocol. Blinding validation is essential in no-treatment controlled trials of acupuncture on infants, where the parents are blinded assessors of symptom reduction. The authors suggest that blinding validation questions, and the answers to these questions, should be reported. Clinical Trial Registry Identifier: NCT00907621.