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

Infant Colic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727530
• Other study ID #: USeville-RMartinez
• Status: Completed
• Phase: N/A
• First received: March 29, 2016
• Last updated: July 11, 2016
• Start date: April 2016
• Est. completion date: July 2016

Study information

• Verified date: April 2016
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Health authority: SPAIN: PORTAL DE ÉTICA DE LA INVESTIGACIÓN BIOMÉDICA DE ANDALUCÍA
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 180 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic
• Infant Colic

Intervention

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.
• ADVICES
Advices for parents to improve the management of infant colic

Locations

Country	Name	City	State
Spain	Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Ernst E. Chiropractic spinal manipulation for infant colic: a systematic review of randomised clinical trials. Int J Clin Pract. 2009 Sep;63(9):1351-3. doi: 10.1111/j.1742-1241.2009.02133.x. Review. — View Citation

Larsen JH. Infants' colic and belly massage. Practitioner. 1990 Apr 22;234(1487):396-7. — View Citation

Olafsdottir E, Forshei S, Fluge G, Markestad T. Randomised controlled trial of infantile colic treated with chiropractic spinal manipulation. Arch Dis Child. 2001 Feb;84(2):138-41. — View Citation

Reinthal M, Lund I, Ullman D, Lundeberg T. Gastrointestinal symptoms of infantile colic and their change after light needling of acupuncture: a case series study of 913 infants. Chin Med. 2011 Aug 11;6:28. doi: 10.1186/1749-8546-6-28. — View Citation

Skjeie H, Skonnord T, Fetveit A, Brekke M. Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice. Scand J Prim Health Care. 2013 Dec;31(4):190-6. doi: 10.3109/02813432.2013.862915. Epub 2013 Nov — View Citation

WESSEL MA, COBB JC, JACKSON EB, HARRIS GS Jr, DETWILER AC. Paroxysmal fussing in infancy, sometimes called colic. Pediatrics. 1954 Nov;14(5):421-35. — View Citation

Wurmser H, Laubereau B, Hermann M, Papousek M, von Kries R. Excessive infant crying: often not confined to the first 3 months of age. Early Hum Dev. 2001 Aug;64(1):1-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No