NCT03326297

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

3.4 years

First QC Date

October 17, 2017

Last Update Submit

November 11, 2020

Conditions

Infantile ColicManual Therapy

Keywords

Infant ColicOsteopathyStressPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline FCL Questionnaire at 12 weeks 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.

    At baseline, at 4 weeks, at 8 weeks, at 12 weeks of infants' life and at 3 months of infants' life

Secondary Outcomes (2)

  • Maternal stress in the last month.

    At baseline and at 12 weeks of infants' life.

  • Intensity of irritability

    At baseline and at 12 weeks of infants' life

Study Arms (3)

Osteopathy manual therapy

EXPERIMENTAL

Osteopathy manual therapy applying the following treatment: Technique for the treatment of parasympathetic innervation, Techniques for the treatment of sympathetic innervation of the digestive system, Functional visceral techniques.

Other: Osteopathy manual therapy

Measures to support and education to the family

ACTIVE COMPARATOR

Measures to support and education to the family that consist on pedagogical intervention in parents, health education.

Behavioral: Measures to support and education to the family

No specific intervention

NO INTERVENTION

No specific intervention, prescriptions by pediatrician

Interventions

Osteopathy manual therapyOTHER

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

Osteopathy manual therapy
Measures to support and education to the familyBEHAVIORAL

Pedagogical intervention in parents and health education

Measures to support and education to the family

Eligibility Criteria

Age3 Weeks - 6 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being diagnosed if Infant Colic.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Almería

Almería, 04120, Spain

Location

Related Publications (23)

  • Gudmundsson G. Infantile colic: is a pain syndrome. Med Hypotheses. 2010 Dec;75(6):528-9. doi: 10.1016/j.mehy.2010.07.014. Epub 2010 Aug 21.

    PMID: 20729004BACKGROUND

  • Kim JS. Acute abdominal pain in children. Pediatr Gastroenterol Hepatol Nutr. 2013 Dec;16(4):219-24. doi: 10.5223/pghn.2013.16.4.219. Epub 2013 Dec 31.

    PMID: 24511517BACKGROUND

  • Cohen-Silver J, Ratnapalan S. Management of infantile colic: a review. Clin Pediatr (Phila). 2009 Jan;48(1):14-7. doi: 10.1177/0009922808323116. Epub 2008 Oct 2.

    PMID: 18832537BACKGROUND

  • Akman I, Kuscu K, Ozdemir N, Yurdakul Z, Solakoglu M, Orhan L, Karabekiroglu A, Ozek E. Mothers' postpartum psychological adjustment and infantile colic. Arch Dis Child. 2006 May;91(5):417-9. doi: 10.1136/adc.2005.083790. Epub 2006 Feb 1.

    PMID: 16452109BACKGROUND

  • Alcantara J, Alcantara JD, Alcantara J. The chiropractic care of infants with colic: a systematic review of the literature. Explore (NY). 2011 May-Jun;7(3):168-74. doi: 10.1016/j.explore.2011.02.002.

    PMID: 21571236BACKGROUND

  • Miller-Loncar C, Bigsby R, High P, Wallach M, Lester B. Infant colic and feeding difficulties. Arch Dis Child. 2004 Oct;89(10):908-12. doi: 10.1136/adc.2003.033233.

    PMID: 15383432BACKGROUND

  • Anabrees J, Indrio F, Paes B, AlFaleh K. Probiotics for infantile colic: a systematic review. BMC Pediatr. 2013 Nov 15;13:186. doi: 10.1186/1471-2431-13-186.

    PMID: 24238101BACKGROUND

  • Levitzky S, Cooper R. Infant colic syndrome--maternal fantasies of aggression and infanticide. Clin Pediatr (Phila). 2000 Jul;39(7):395-400. doi: 10.1177/000992280003900703.

    PMID: 10914303BACKGROUND

  • Hall B, Chesters J, Robinson A. Infantile colic: a systematic review of medical and conventional therapies. J Paediatr Child Health. 2012 Feb;48(2):128-37. doi: 10.1111/j.1440-1754.2011.02061.x. Epub 2011 Apr 7.

    PMID: 21470331BACKGROUND

  • Sung V, Collett S, de Gooyer T, Hiscock H, Tang M, Wake M. Probiotics to prevent or treat excessive infant crying: systematic review and meta-analysis. JAMA Pediatr. 2013 Dec;167(12):1150-7. doi: 10.1001/jamapediatrics.2013.2572.

    PMID: 24100440BACKGROUND

  • Cetinkaya B, Basbakkal Z. The effectiveness of aromatherapy massage using lavender oil as a treatment for infantile colic. Int J Nurs Pract. 2012 Apr;18(2):164-9. doi: 10.1111/j.1440-172X.2012.02015.x.

    PMID: 22435980BACKGROUND

  • Tekgunduz KS, Gurol A, Apay SE, Caner I. Effect of abdomen massage for prevention of feeding intolerance in preterm infants. Ital J Pediatr. 2014 Nov 14;40:89. doi: 10.1186/s13052-014-0089-z.

    PMID: 25394549BACKGROUND

  • Savino F, Ceratto S, De Marco A, Cordero di Montezemolo L. Looking for new treatments of Infantile Colic. Ital J Pediatr. 2014 Jun 5;40:53. doi: 10.1186/1824-7288-40-53.

    PMID: 24898541BACKGROUND

  • 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: 24228748BACKGROUND

  • Savino F, Tarasco V. New treatments for infant colic. Curr Opin Pediatr. 2010 Dec;22(6):791-7. doi: 10.1097/MOP.0b013e32833fac24.

    PMID: 20859207BACKGROUND

  • Ernst E. Chiropractic treatment for gastrointestinal problems: a systematic review of clinical trials. Can J Gastroenterol. 2011 Jan;25(1):39-40. doi: 10.1155/2011/910469.

    PMID: 21258667BACKGROUND

  • Wiberg KR, Wiberg JM. A retrospective study of chiropractic treatment of 276 danish infants with infantile colic. J Manipulative Physiol Ther. 2010 Sep;33(7):536-41. doi: 10.1016/j.jmpt.2010.08.004.

    PMID: 20937431BACKGROUND

  • Miller JE, Newell D, Bolton JE. Efficacy of chiropractic manual therapy on infant colic: a pragmatic single-blind, randomized controlled trial. J Manipulative Physiol Ther. 2012 Oct;35(8):600-7. doi: 10.1016/j.jmpt.2012.09.010.

    PMID: 23158465BACKGROUND

  • Miller JE, Phillips HL. Long-term effects of infant colic: a survey comparison of chiropractic treatment and nontreatment groups. J Manipulative Physiol Ther. 2009 Oct;32(8):635-8. doi: 10.1016/j.jmpt.2009.08.017.

    PMID: 19836599BACKGROUND

  • 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: 11159288BACKGROUND

  • Wiberg JM, Nordsteen J, Nilsson N. The short-term effect of spinal manipulation in the treatment of infantile colic: a randomized controlled clinical trial with a blinded observer. J Manipulative Physiol Ther. 1999 Oct;22(8):517-22. doi: 10.1016/s0161-4754(99)70003-5.

    PMID: 10543581BACKGROUND

  • Posadzki P, Lee MS, Ernst E. Osteopathic manipulative treatment for pediatric conditions: a systematic review. Pediatrics. 2013 Jul;132(1):140-52. doi: 10.1542/peds.2012-3959. Epub 2013 Jun 17.

    PMID: 23776117BACKGROUND

  • Dobson D, Lucassen PL, Miller JJ, Vlieger AM, Prescott P, Lewith G. Manipulative therapies for infantile colic. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD004796. doi: 10.1002/14651858.CD004796.pub2.

    PMID: 23235617BACKGROUND

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

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

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 31, 2017

Study Start

January 1, 2017

Primary Completion

June 1, 2020

Study Completion

November 1, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations

ES(1)