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Infantile ColicNCT03326297

Physiotherapy and Osteopathy on Infant Colic

A study testing Osteopathy manual therapy and Measures to support and education to the family in people with Infantile Colic and Manual Therapy, run by Universidad de Almeria at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 3 to 6 weeks
Conditions the study is for
Infantile Colic, Manual Therapy
What is being tested?
Osteopathy manual therapy and Measures to support and education to the family
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSpain
Study dates
Jan 2017to Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 6 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Being diagnosed if Infant Colic.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad de Almería

    Almería, 04120

Other trials in Spain

About this study

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

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.

Read the detailed 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.

Being tested
Osteopathy manual therapy, Measures to support and education to the family
Keywords
Infant Colic, Osteopathy, Stress, Physiotherapy
Medical subject headings
Colic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Osteopathy manual therapyOther

    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 familyBehavioural

    Pedagogical intervention in parents and health education

Study groups in NCT03326297
Study groupRoleWhat they receive
Osteopathy manual therapyExperimentalOsteopathy 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.
Receives: Other: Osteopathy manual therapy
Measures to support and education to the familyActive comparatorMeasures to support and education to the family that consist on pedagogical intervention in parents, health education.
Receives: Behavioral: Measures to support and education to the family
No specific interventionNo interventionNo specific intervention, prescriptions by pediatrician

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

  1. Maternal stress in the last month.

    Perceived Stress Questionnaire (PSQ).

    Measured: At baseline and at 12 weeks of infants' life.

  2. Intensity of irritability

    Analogue visual scale from 0 to 6.

    Measured: At baseline and at 12 weeks of infants' life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2017
  2. Study startJan 2017
  3. Primary completionJun 2020
  4. Study completionNov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03326297
Sponsor's protocol ID
PI-0021-2015
Status last verified
Nov 2020
First submitted
17 Oct 2017
Last updated
13 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 20729004

  • 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.

    PubMed 24511517

  • 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.

    PubMed 18832537

  • 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.

    PubMed 16452109

  • 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.

    PubMed 21571236

  • 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.

    PubMed 15383432

  • 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.

    PubMed 24238101

  • 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.

    PubMed 10914303

  • 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.

    PubMed 21470331

  • 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.

    PubMed 24100440

  • 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.

    PubMed 22435980

  • 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.

    PubMed 25394549

  • 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.

    PubMed 24898541

  • 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.

    PubMed 24228748

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

    PubMed 20859207

Questions about this trial

What is this clinical trial studying?

A study testing Osteopathy manual therapy and Measures to support and education to the family in people with Infantile Colic and Manual Therapy, run by Universidad de Almeria at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline FCL Questionnaire at 12 weeks of infants' life. (time frame: At baseline, at 4 weeks, at 8 weeks, at 12 weeks of infants' life and at 3 months of infants' life). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03326297, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.

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