Effects of Osteopathic Manual Therapy on Infant Colic

NCT ID: NCT04841590

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2024-12-30

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).

Conditions

Colic, Infantile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group

The experimental group (EG) will receive treatment through the use of manual physiotherapy techniques such as mobilization techniques in the spinal column, cranial techniques and visceral mobilization applied by gentle pressure, according to the therapist's diagnostic criteria after performing palpatory and mobility tests.

Group Type: EXPERIMENTAL

Intervention of the experimental group (EG)

Intervention Type: OTHER

Treatment through the use of manual physiotherapy techniques such as mobilization techniques in the spinal column, cranial techniques and visceral mobilization applied by gentle pressure, according to the therapist's diagnostic criteria after performing palpatory and mobility tests.

Control Group

The control group (CG) will not receive any treatment

Group Type: SHAM_COMPARATOR

Control Group (CG)

Intervention Type: OTHER

Subjects in the control group (CG) will not receive any treatment

Interventions

Intervention of the experimental group (EG)

Treatment through the use of manual physiotherapy techniques such as mobilization techniques in the spinal column, cranial techniques and visceral mobilization applied by gentle pressure, according to the therapist's diagnostic criteria after performing palpatory and mobility tests.

Intervention Type: OTHER

Control Group (CG)

Subjects in the control group (CG) will not receive any treatment

Intervention Type: OTHER

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.

• Minimum Eligible Age: 2 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

David Nuñez Fernandez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Nuñez Fernandez, PT, MsC

Role: PRINCIPAL_INVESTIGATOR

University of Seville

Locations

Clinica de Fisioterapia y Osteopatía M4

Granada, Granada, Spain

Hospital del Sureste

Madrid, Madrid, Spain

Fisioterapia y Osteopatía David Nuñez

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

380263

Identifier Type: -

Identifier Source: org_study_id