Physiotherapy and Osteopathy on Infant Colic

Effectiveness of Manual Therapy Through Osteopathy in the Treatment of Infant Colic.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03326297

Enrollment

120

Registered

2017-10-31

Start date

2017-01-31

Completion date

2020-11-30

Last updated

2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infantile Colic, Manual Therapy

Keywords

Infant Colic, Osteopathy, Stress, Physiotherapy

Brief summary

This study compares the effectiveness of manual therapy (osteopathy) on infant colic versus education to the family, and a third group with no specific intervention.

Detailed description

Infant colic is a problem that affects 10-30% of babies in their first months of life. This research project aims to verify the effectiveness of manual therapy on infant colic. The sample is divided in three groups, performing in the firts one osteopathy manual therapy; in the second one, measures to support and education to the family; and in the third, there is no specific intervention.

Interventions

OTHEROsteopathy manual therapy

Technique for the treatment of parasympathetic innervation, Techniques for the treatment of sympathetic innervation of the digestive system, Functional visceral techniques.

BEHAVIORALMeasures to support and education to the family

Pedagogical intervention in parents and health education

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Weeks to 6 Weeks

Healthy volunteers

Inclusion criteria

* Being diagnosed if Infant Colic.

Exclusion criteria

* Babies diagnosed of other pathologies that justify cries, such as reflux, food intolerances or neurological syndromes. * Premature babies less than 37 weeks gestation, who may be involved in other concomitant pathologies. * Mothers (families) with language barriers, due to the difficulty of collecting data.

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline FCL Questionnaire at 12 weeks of infants' life.	At baseline, at 4 weeks, at 8 weeks, at 12 weeks of infants' life and at 3 months of infants' life	FCL (Fisioterapia en el Cólico del Lactante) QUESTIONNAIRE: Infant colic assessment questionnaire. Group CTS (Ciencias y Técnicas de la Salud) 305 of the University of Seville.

Secondary

Measure	Time frame	Description
Maternal stress in the last month.	At baseline and at 12 weeks of infants' life.	Perceived Stress Questionnaire (PSQ).
Intensity of irritability	At baseline and at 12 weeks of infants' life	Analogue visual scale from 0 to 6.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026