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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| No specific intervention | No Intervention | No specific intervention, prescriptions by pediatrician |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathy manual therapy | Other | Technique for the treatment of parasympathetic innervation, Techniques for the treatment of sympathetic innervation of the digestive system, Functional visceral techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal stress in the last month. | Perceived Stress Questionnaire (PSQ). | At baseline and at 12 weeks of infants' life. |
| Intensity of irritability | Analogue visual scale from 0 to 6. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de AlmerÃa | AlmerÃa | 04120 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20729004 | Background | 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. | |
| 24511517 | Background | 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. |
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| ID | Term |
|---|---|
| D003085 | Colic |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Measures to support and education to the family | Behavioral | Pedagogical intervention in parents and health education |
|
| At baseline and at 12 weeks of infants' life |
| 18832537 | Background | 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. |
| 16452109 | Background | 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. |
| 21571236 | Background | 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. |
| 15383432 | Background | 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. |
| 24238101 | Background | 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. |
| 10914303 | Background | 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. |
| 21470331 | Background | 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. |
| 24100440 | Background | 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. |
| 22435980 | Background | 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. |
| 25394549 | Background | 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. |
| 24898541 | Background | 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. |
| 24228748 | Background | 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. |
| 20859207 | Background | Savino F, Tarasco V. New treatments for infant colic. Curr Opin Pediatr. 2010 Dec;22(6):791-7. doi: 10.1097/MOP.0b013e32833fac24. |
| 21258667 | Background | 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. |
| 20937431 | Background | 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. |
| 23158465 | Background | 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. |
| 19836599 | Background | 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. |
| 11159288 | Background | 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. |
| 10543581 | Background | 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. |
| 23776117 | Background | 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. |
| 23235617 | Background | 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. |
| 41793293 | Derived | Martinez-Lentisco MDM, Carreno-Segura S, Leon-Morillas F, Garcia-Torrecillas JM. Impact of an Educational Programme in Primary Care for mothers With Infant Colic Babies: Quasi-Experimental Study. Clin Pediatr (Phila). 2026 Jul;65(7):887-893. doi: 10.1177/00099228261423662. Epub 2026 Mar 7. |