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Completed

NCT Number: NCT03326297

Physiotherapy and Osteopathy on 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.

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Key information

Conditions

Infantile Colic Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Manual Therapy

Age range

3 week–6 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Almería

Almería, 04120, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Osteopathy manual therapy

Other

Technique for the treatment of parasympathetic innervation, Techniques for the treatment of sympathetic innervation of the digestive system, Functional visceral techniques.

Measures to support and education to the family

Behavioral

Pedagogical intervention in parents and health education

Primary outcomes

  1. 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.

Secondary outcomes

  1. Maternal stress in the last month.

    Time frame: At baseline and at 12 weeks of infants' life.

    Perceived Stress Questionnaire (PSQ).

  2. Intensity of irritability

    Time frame: At baseline and at 12 weeks of infants' life

    Analogue visual scale from 0 to 6.

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 31, 2017
Registry last updated
Nov 13, 2020

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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