Physiotherapy and Osteopathy on Infant Colic

November 11, 2020 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain, 04120
        • Universidad de Almeria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 weeks to 1 month (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: Osteopathy manual therapy
Technique for the treatment of parasympathetic innervation, Techniques for the treatment of sympathetic innervation of the digestive system, Functional visceral techniques.
ACTIVE_COMPARATOR: 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.
Behavioral: Measures to support and education to the family
Pedagogical intervention in parents and health education
NO_INTERVENTION: No specific intervention
No specific intervention, prescriptions by pediatrician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline FCL Questionnaire at 12 weeks of infants' life.
Time Frame: 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.
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.
Time Frame: At baseline and at 12 weeks of infants' life.
Perceived Stress Questionnaire (PSQ).
At baseline and at 12 weeks of infants' life.
Intensity of irritability
Time Frame: At baseline and at 12 weeks of infants' life
Analogue visual scale from 0 to 6.
At baseline and at 12 weeks of infants' life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

June 1, 2020

Study Completion (ACTUAL)

November 1, 2020

Study Registration Dates

First Submitted

October 17, 2017

First Submitted That Met QC Criteria

October 25, 2017

First Posted (ACTUAL)

October 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 11, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-0021-2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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