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

NCT02727530 | Completed

• 1 other identifier: USeville-RMartinez
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Colic

Keywords

Infant Colic; Manual Therapy; Effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

GROUP RECEIVING VISCERAL MANUAL THERAPY-ADVICES

EXPERIMENTAL

Subjects will receive 2 manual therapy sessions and advices.

Other: VISCERAL MANUAL THERAPY-ADVICES; Other: ADVICES

GROUP RECEIVING ADVICES

EXPERIMENTAL

Subjects will receive advices.

Other: ADVICES

Interventions

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.

GROUP RECEIVING VISCERAL MANUAL THERAPY-ADVICES

ADVICES OTHER

Advices for parents to improve the management of infant colic

GROUP RECEIVING ADVICES; GROUP RECEIVING VISCERAL MANUAL THERAPY-ADVICES

Eligibility Criteria

• Age: 1 Day - 180 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants with medical diagnostic of colic following Wessel criteria.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

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

Seville, Sevilla, 41009, Spain

Location

Related Publications (7)

• 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. No abstract available.

  PMID: 13214956 RESULT

• 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. doi: 10.1016/s0378-3782(01)00166-9.

  PMID: 11408103 RESULT

• 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.

  PMID: 19691620 RESULT

• 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. doi: 10.1136/adc.84.2.138.

  PMID: 11159288 RESULT

• 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.

  PMID: 21835014 RESULT

• 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 15.

  PMID: 24228748 RESULT

• Larsen JH. Infants' colic and belly massage. Practitioner. 1990 Apr 22;234(1487):396-7. No abstract available.

  PMID: 2367295 RESULT

MeSH Terms

Conditions

Colic

Interventions

Counseling

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 4, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 12, 2016

Record last verified: 2016-04

Locations

ES (1)