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

Study Overview
=================
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.

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

Conditions
-----------------
Infant Colic

Intervention / Treatment
-----------------
* Other: VISCERAL MANUAL THERAPY-ADVICES
* Other: ADVICES


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 180 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GROUP RECEIVING VISCERAL MANUAL THERAPY-ADVICES<br>Subjects will receive 2 manual therapy sessions and advices. | Other: VISCERAL MANUAL THERAPY-ADVICES<br>* 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.<br>Other: ADVICES<br>* Advices for parents to improve the management of infant colic<br>|
| Experimental: GROUP RECEIVING ADVICES<br>Subjects will receive advices. | Other: ADVICES<br>* Advices for parents to improve the management of infant colic<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from parents-reported infant colic severity at 3 weeks | 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 | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infant Colic, Manual Therapy, Effectiveness