Effects of Osteopathic Manual Therapy on Infant Colic

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    75
  • sponsor
    University of Seville
Updated on 23 May 2022
physiotherapy
manual therapy
infantile colic

Summary

Infant colic (CL) is a common disorder that affects approximately 8-33% of newborns during the first months of life. Typically defined as "crying that lasts at least 3 hours a day, and occurs at least 3 days a week over a 3-week period." Osteopathic manual therapy is presented as an effective and safe alternative to CL treatment.

The main objective of the study is to quantify possible changes in daily crying hours and hours of sleep, the severity of CL, the frequency of episodes, changes in stool and possible adverse effects.

The study hypothesis argues that the application of osteopathic manual therapy in babies with CL produces an improvement in the hours of daily crying, the frequency of episodes, the severity of colic and the hours of sleep. A controlled RCT will be performed where the evaluator and the parents will be blinded with respect to the allocation group for each subject. Subjects who meet the inclusion and exclusion criteria will be randomly assigned to the experimental group (EG), placebo group (PG) and control group (CG) using a table of random numbers by a person from outside the research. The EG diagnosis treatment using techniques of osteopathic manual therapy, vertebral mobilization, cranial techniques and visceral mobilization, according to the diagnostic criteria of the therapist. The PG will be made up of those subjects who have been randomly assigned to said group, and completed with those whose parents do not accept the condition of blinding. Subjects belonging to this group will receive the application of the turned off ultrasound applied to the abdominal region for 10 minutes. The CG has no treatment.

A total of 3 procedures were performed, one per week, problems with the chronology in all groups (days 0, 7 and 14 if required).

The therapist in charge of performing the operations will be a Physiotherapist and Osteopath with more than 10 years of experience.

The evaluations will be carried out by a healthcare professional with more than 10 years of experience. The evaluator will be blinded. Parents blinded with respect to the allocation group of each subject until the end of the study.

To analyze the main variable of the study (total hours of excessive crying per day), use the crying diary completed by the parents. The Infantile Colic Severity Questionnaire (ICSQ) will be applied to evaluate the secondary variables (sleep, feces, frequency of episodes and severity of colic).

Details
Condition Colic, Infantile
Treatment Control group (CG), Intervention of the experimental group (EG), Placebo Group (PG)
Clinical Study IdentifierNCT04841590
SponsorUniversity of Seville
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Inconsolable crying for more than 3 hours a day, at least 3 days a week for at least 3 weeks
Age 2 - 12 weeks
Gestation equal to or greater than 38 weeks
Birth weight equal to or greater than 2,500 grams
Weight gain of at least 150 grams. per week
Appropriate pediatric general physical examination (height, weight, head circumference and psychomotor development)
Sign the informed consent

Exclusion Criteria

Signs and / or symptoms of other pathologies
Signs of lactose intolerance
Having had benefits with the withdrawal of milk from maternal feeding or the use of milk with hydrolyzed casein
Having received the subjects and / or siblings, previous treatment with Osteopathy and / or Chiropractic
Contraindication to the treatment and / or some of its techniques; presence of congenital malformations
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