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

Primary Purpose

Infant Colic

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

VISCERAL MANUAL THERAPY-ADVICES

ADVICES

About this trial

This is an interventional treatment trial for Infant Colic focused on measuring Infant Colic, Manual Therapy, Effectiveness

Eligibility Criteria

1 Day - 180 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

GROUP RECEIVING VISCERAL MANUAL THERAPY-ADVICES

GROUP RECEIVING ADVICES

Arm Description

Subjects will receive 2 manual therapy sessions and advices.

Subjects will receive advices.

Outcomes

Primary Outcome Measures

Change from parents-reported infant colic severity at 3 weeks

Evaluated by the infant colic severity scale

Secondary Outcome Measures

Change from parents-reported infant cry at 3 weeks

Evaluated by cry-related items of the infant colic severity scale

Full Information

NCT ID

NCT02727530

First Posted

March 29, 2016

Last Updated

July 11, 2016

Sponsor

University of Seville

1. Study Identification

Unique Protocol Identification Number

NCT02727530

Brief Title

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

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Seville

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infant Colic

Keywords

Infant Colic, Manual Therapy, Effectiveness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GROUP RECEIVING VISCERAL MANUAL THERAPY-ADVICES

Arm Type

Experimental

Arm Description

Subjects will receive 2 manual therapy sessions and advices.

Arm Title

GROUP RECEIVING ADVICES

Arm Type

Experimental

Arm Description

Subjects will receive advices.

Intervention Type

Other

Intervention Name(s)

VISCERAL MANUAL THERAPY-ADVICES

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

ADVICES

Intervention Description

Advices for parents to improve the management of infant colic

Primary Outcome Measure Information:

Title

Change from parents-reported infant colic severity at 3 weeks

Description

Evaluated by the infant colic severity scale

Time Frame

At the start of the study and one week after the second session (three weeks after the start of the study)

Secondary Outcome Measure Information:

Title

Change from parents-reported infant cry at 3 weeks

Description

Evaluated by cry-related items of the infant colic severity scale

Time Frame

At the start of the study and one week after the second session (three weeks after the start of the study)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

180 Days

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

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

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

13214956

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.

Results Reference

result

PubMed Identifier

11408103

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.

Results Reference

result

PubMed Identifier

19691620

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.

Results Reference

result

PubMed Identifier

11159288

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.

Results Reference

result

PubMed Identifier

21835014

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.

Results Reference

result

PubMed Identifier

24228748

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.

Results Reference

result

PubMed Identifier

2367295

Citation

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

Results Reference

result

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

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