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Completed

NCT Number: NCT02727530

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

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.

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Key information

Age range

1 day–180 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla

Seville, Sevilla, 41009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VISCERAL MANUAL THERAPY-ADVICES

Other

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.

ADVICES

Other

Advices for parents to improve the management of infant colic

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2016
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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