Clinical trial NCT04841590: Effects of Osteopathic Manual Therapy on Infant Colic
Official title: Effects of Osteopathic Manual Therapy on Infant Colic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colic, Infantile
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled experimental clinical trial will be conducted where the evaluator and parents will be blinded to the allocation group for each subject
Primary purpose: TREATMENT

Brief 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) 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 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Total hours of crying per day
timeFrame: At the beginning of the study (pre-intervention)
measure: Total hours of crying per day
timeFrame: 1 week after the first intervention
measure: Total hours of crying per day
timeFrame: 2 weeks after the first intervention
measure: Total hours of crying per day
timeFrame: 3 weeks after the first intervention
measure: Total hours of crying per day
timeFrame: Finally at 4 weeks from the first intervention
measure: Frequency of episodes
timeFrame: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
measure: Frequency of episodes
timeFrame: 1 week after the first intervention
measure: Frequency of episodes
timeFrame: 2 weeks after the first intervention
measure: Frequency of episodes
timeFrame: 3 weeks after the first intervention
measure: Frequency of episodes
timeFrame: Finally at 4 weeks from the first intervention
Secondary outcomes:
measure: Colic Severity
timeFrame: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
measure: Hours of sleep
timeFrame: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
measure: Stool
timeFrame: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
measure: Use of drugs
timeFrame: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Clinica de Fisioterapia y Osteopatía M4
city: Madrid
country: Spain
facility: Hospital del Sureste
city: Madrid
country: Spain
facility: Fisioterapia y Osteopatía David Nuñez
Study officials:
affiliation: University of Seville
name: David Nuñez Fernandez, PT, MsC
role: PRINCIPAL_INVESTIGATOR
References: