The Effectiveness of the Manual Therapy on Infant Colic (MT-IF)

July 11, 2016 updated by: Raquel Chillón Martínez, University of Seville

The Effects of Visceral Manual Therapy on Infant Colic Symptoms. A Controlled Clinical Trial

The main goal of this study is to get to know if applying manual therapy will reduce the infant colic symptoms for to improve quality of life of babies and parents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

Infant colic is one of the most common disorders in the first year of baby´s life. It is estimated to affect between 10 to 40 % of healthy born children in their first year of life. To determine the effectiveness of a protocol manual therapy in the treatment of colic, using the Infant Colic Severity Questionnaire, we analyzed two intervention groups: experimental in which children received the protocol manual therapy and counseling to parents and the Control group, in which parents received advice only.

Objectives:

To assess the effectiveness of visceral manual therapy to improve the symptoms on infant colic.

Study Type

Interventional

Enrollment (Actual)

50

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
      • Sevilla, Spain, 41009
        • Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla

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

1 day to 5 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants with medical diagnostic of colic following Wessel criteria.

Exclusion Criteria:

  • Infant's parents without full capacity to answer the survey questions, such as the existence of intellectual disability.
  • Babies with neurological disorders such epilepsy, meningitis, encephalitis, cerebral palsy, spina bifida, hydrocephalus, encephalopathy, Arnold Chiari malformation, syringomyelia and Huntington's disease.
  • Babies with digestive disorders, such Crohn's disease, irritable bowel syndrome, peritonitis, intestinal malabsorption, hepatitis, diverticular bowel disease, esophagitis, Intussusception and Ulcerative Colitis.
  • Babies with congenital diseases such Angelmen syndrome, Down syndrome, cystic fibrosis, haemophilia, Klinefelter syndrome, Neurofibromatosis, Patau syndrome and Tay Sachs syndrome.
  • Babies with traumatology - orthopedic pathologies such idiopathic scoliosis, spondylolisthesis, Perthes disease, Meyer dysplasia, Marfan syndrome, Morquio syndrome and congenital hip dislocation.
  • Babies with dermatological diseases such Atopic dermatitis, staphylococcal scalded skin syndrome, psoriasis, urticaria and disorders of skin pigmentation.
  • Babies who are subjected to drug treatments that are not specific to the treatment of colic.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP RECEIVING VISCERAL MANUAL THERAPY-ADVICES
Subjects will receive 2 manual therapy sessions and advices.
Other: VISCERAL MANUAL THERAPY-ADVICES
The subjects of this group will receive an amount of two sessions of visceral manual therapy that will be applied within two weeks. In the first session will be applied procedures in the most superficial body structures. And, in the second session will be applied procedures in the most deep body structures.
Other: ADVICES
Advices for parents to improve the management of infant colic
Experimental: GROUP RECEIVING ADVICES
Subjects will receive advices.
Other: ADVICES
Advices for parents to improve the management of infant colic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from parents-reported infant colic severity at 3 weeks
Time Frame: At the start of the study and one week after the second session (three weeks after the start of the study)
Evaluated by the infant colic severity scale
At the start of the study and one week after the second session (three weeks after the start of the study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from parents-reported infant cry at 3 weeks
Time Frame: At the start of the study and one week after the second session (three weeks after the start of the study)
Evaluated by cry-related items of the infant colic severity scale
At the start of the study and one week after the second session (three weeks after the start of the study)

Collaborators and Investigators

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

Sponsor

University of Seville

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

April 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USeville-RMartinez

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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