Infantile Colic Clinical Trial
Official title:
Effectiveness of Manual Therapy Through Osteopathy in the Treatment of Infant Colic.
NCT number | NCT03326297 |
Other study ID # | PI-0021-2015 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | November 2020 |
Verified date | November 2020 |
Source | Universidad de Almeria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad de Almería | Almería |
Lead Sponsor | Collaborator |
---|---|
Universidad de Almeria |
Spain,
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
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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
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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
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 |
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