Back to resultsPhysiotherapy and Osteopathy on Infant Colic
Primary Purpose
Infantile Colic, Manual Therapy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Osteopathy manual therapy
Measures to support and education to the family
Sponsored by
About this trial
This is an interventional treatment trial for Infantile Colic focused on measuring Infant Colic, Osteopathy, Stress, Physiotherapy
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.
Sites / Locations
- Universidad de Almería
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Osteopathy manual therapy
Measures to support and education to the family
No specific intervention
Arm Description
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 that consist on pedagogical intervention in parents, health education.
No specific intervention, prescriptions by pediatrician
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Maternal stress in the last month.
Perceived Stress Questionnaire (PSQ).
Intensity of irritability
Analogue visual scale from 0 to 6.
Full Information
NCT ID
NCT03326297
First Posted
October 17, 2017
Last Updated
November 11, 2020
Sponsor
Universidad de Almeria
1. Study Identification
Unique Protocol Identification Number
NCT03326297
Brief Title
Physiotherapy and Osteopathy on Infant Colic
Official Title
Effectiveness of Manual Therapy Through Osteopathy in the Treatment of Infant Colic.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
November 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Colic, Manual Therapy
Keywords
Infant Colic, Osteopathy, Stress, Physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Osteopathy manual therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Measures to support and education to the family
Arm Type
Active Comparator
Arm Description
Measures to support and education to the family that consist on pedagogical intervention in parents, health education.
Arm Title
No specific intervention
Arm Type
No Intervention
Arm Description
No specific intervention, prescriptions by pediatrician
Intervention Type
Other
Intervention Name(s)
Osteopathy manual therapy
Intervention Description
Technique for the treatment of parasympathetic innervation, Techniques for the treatment of sympathetic innervation of the digestive system, Functional visceral techniques.
Intervention Type
Behavioral
Intervention Name(s)
Measures to support and education to the family
Intervention Description
Pedagogical intervention in parents and health education
Primary Outcome Measure Information:
Title
Change from baseline FCL Questionnaire at 12 weeks of infants' life.
Description
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.
Time Frame
At baseline, at 4 weeks, at 8 weeks, at 12 weeks of infants' life and at 3 months of infants' life
Secondary Outcome Measure Information:
Title
Maternal stress in the last month.
Description
Perceived Stress Questionnaire (PSQ).
Time Frame
At baseline and at 12 weeks of infants' life.
Title
Intensity of irritability
Description
Analogue visual scale from 0 to 6.
Time Frame
At baseline and at 12 weeks of infants' life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Weeks
Maximum Age & Unit of Time
6 Weeks
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Universidad de Almería
City
Almería
ZIP/Postal Code
04120
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
20729004
Citation
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Physiotherapy and Osteopathy on Infant Colic
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