Physiotherapy and Osteopathy on Infant Colic

Not Applicable

Completed

• Conditions: Infantile Colic; Manual Therapy
• Interventions: Other: Osteopathy manual therapy; Behavioral: Measures to support and education to the family

• Registration Number: NCT03326297
• Lead Sponsor: Universidad de Almeria

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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-31
• Primary Completion: 2020-06
• Status Verified: 2020-11
• Study Completion: 2020-11
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Being diagnosed if Infant Colic.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osteopathy manual therapy	Osteopathy manual therapy	Osteopathy manual therapy applying the following treatment: Technique for the treatment of parasympathetic innervation, Techniques for the treatment of sympathetic innervation of the digestive system, Functional visceral techniques.
Measures to support and education to the family	Measures to support and education to the family	Measures to support and education to the family that consist on pedagogical intervention in parents, health education.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Universidad de Almería; 🇪🇸 Almería, Spain