Clinical trial NCT03326297: Physiotherapy and Osteopathy on Infant Colic
Official title: Effectiveness of Manual Therapy Through Osteopathy in the Treatment of Infant Colic.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infantile Colic
Manual Therapy
Keywords: Infant Colic
Osteopathy
Stress
Physiotherapy
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline FCL Questionnaire at 12 weeks of infants' life.
timeFrame: At baseline, at 4 weeks, at 8 weeks, at 12 weeks of infants' life and at 3 months of infants' life
Secondary outcomes:
measure: Maternal stress in the last month.
timeFrame: At baseline and at 12 weeks of infants' life.
measure: Intensity of irritability
timeFrame: At baseline and at 12 weeks of infants' life
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Universidad de Almería
Study officials:
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