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

Not Applicable

Completed

• Conditions: Infant Colic
• Interventions: Other: ADVICES; Other: VISCERAL MANUAL THERAPY-ADVICES

• Registration Number: NCT02727530
• Lead Sponsor: University of Seville

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-03-29
• Status Verified: 2016-04
• Study Start: 2016-04
• Study First Posted: 2016-04-04
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP RECEIVING ADVICES	ADVICES	Subjects will receive advices.
GROUP RECEIVING VISCERAL MANUAL THERAPY-ADVICES	ADVICES	Subjects will receive 2 manual therapy sessions and advices.
GROUP RECEIVING VISCERAL MANUAL THERAPY-ADVICES	VISCERAL MANUAL THERAPY-ADVICES	Subjects will receive 2 manual therapy sessions and advices.

Primary Outcome Measures

Name	Time	Method
Change from parents-reported infant colic severity at 3 weeks	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

Secondary Outcome Measures

Name	Time	Method
Change from parents-reported infant cry at 3 weeks	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

Trial Locations

Locations (1)

Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla; 🇪🇸 Sevilla, Spain