Clinical trial NCT02727530: The Effectiveness of the Manual Therapy on Infant Colic (MT-IF)
Official title: The Effects of Visceral Manual Therapy on Infant Colic Symptoms. A Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Colic
Keywords: Infant Colic
Manual Therapy
Effectiveness
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 180
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from parents-reported infant colic severity at 3 weeks
timeFrame: At the start of the study and one week after the second session (three weeks after the start of the study)
Secondary outcomes:
measure: Change from parents-reported infant cry at 3 weeks
timeFrame: At the start of the study and one week after the second session (three weeks after the start of the study)
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla
Study officials:
References:
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. No abstract available.
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. doi: 10.1016/s0378-3782(01)00166-9.
citation: 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.
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. doi: 10.1136/adc.84.2.138.
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.
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 15.
citation: Larsen JH. Infants' colic and belly massage. Practitioner. 1990 Apr 22;234(1487):396-7. No abstract available.