Physiotherapy and Osteopathy on Infant Colic

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infantile Colic, Manual Therapy

Intervention / Treatment
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* Other: Osteopathy manual therapy
* Behavioral: Measures to support and education to the family


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Weeks
Maximum Age: 6 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteopathy manual therapy<br>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. | Other: Osteopathy manual therapy<br>* Technique for the treatment of parasympathetic innervation, Techniques for the treatment of sympathetic innervation of the digestive system, Functional visceral techniques.<br>|
| Active Comparator: Measures to support and education to the family<br>Measures to support and education to the family that consist on pedagogical intervention in parents, health education. | Behavioral: Measures to support and education to the family<br>* Pedagogical intervention in parents and health education<br>|
| No Intervention: No specific intervention<br>No specific intervention, prescriptions by pediatrician | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline FCL Questionnaire at 12 weeks 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. | At baseline, at 4 weeks, at 8 weeks, at 12 weeks of infants' life and at 3 months of infants' life | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant Colic, Osteopathy, Stress, Physiotherapy