Physiotherapy and Osteopathy on Infant Colic

Infantile Colic Clinical Trial

Official title:

Effectiveness of Manual Therapy Through Osteopathy in the Treatment of Infant Colic.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326297
• Other study ID #: PI-0021-2015
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: November 2020

Study information

• Verified date: November 2020
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Infant colic is a problem that affects 10-30% of babies in their first months of life. This research project aims to verify the effectiveness of manual therapy on infant colic. The sample is divided in three groups, performing in the firts one osteopathy manual therapy; in the second one, measures to support and education to the family; and in the third, there is no specific intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Weeks

Eligibility

Inclusion Criteria:

• Being diagnosed if Infant Colic.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Colic
• Infantile Colic
• Manual Therapy

Intervention

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

Behavioral:
• Measures to support and education to the family
Pedagogical intervention in parents and health education

Locations

Country	Name	City	State
Spain	Universidad de Almería	Almería

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

References & Publications (23)

Akman I, Kusçu 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. Epub 2006 Feb 1. — View Citation

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.2011.02.00. Review. — View Citation

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. Review. — View Citation

Çetinkaya 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. — View Citation

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. Review. — View Citation

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:CD004796. doi: 10.1002/14651858.CD004796.pub2. Review. — View Citation

Ernst E. Chiropractic treatment for gastrointestinal problems: a systematic review of clinical trials. Can J Gastroenterol. 2011 Jan;25(1):39-40. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Levitzky S, Cooper R. Infant colic syndrome--maternal fantasies of aggression and infanticide. Clin Pediatr (Phila). 2000 Jul;39(7):395-400. — View Citation

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. — View Citation

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. — View Citation

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. — 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

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. Review. — View Citation

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. Review. — View Citation

Savino F, Tarasco V. New treatments for infant colic. Curr Opin Pediatr. 2010 Dec;22(6):791-7. doi: 10.1097/MOP.0b013e32833fac24. Review. — 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 15. — View Citation

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. Review. — View Citation

Tekgündüz KS, Gürol 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maternal stress in the last month.	Perceived Stress Questionnaire (PSQ).	At baseline and at 12 weeks of infants' life.
Secondary	Intensity of irritability	Analogue visual scale from 0 to 6.	At baseline and at 12 weeks of infants' life