Cranial Osteopathy in Infantile Colic

Not Applicable

• Conditions: Infantile Colic
• Interventions: Other: Usual NHS Care; Other: Osteopathic Manipulative Therapy

• Registration Number: NCT01942928
• Lead Sponsor: European School of Osteopathy

Brief Summary

Background Excessive Crying (Infantile Colic) is one of the most common complaints for which parents seek treatment. These otherwise healthy and well fed infants show no signs of failure to thrive, cry without identifiable cause, fuss a lot and are hard-to-soothe.

Objective To explore the feasibility of running a Randomised Controlled Trial (RCT) that investigates the effectiveness of cranial osteopathy in addition to usual National Health Service (NHS) care in infants with colic.

Methods Pragmatic randomised controlled trial, involving United Kingdom (UK) osteopaths in private practice and NHS health visitors. Parents of 60 excessively crying infants/infants with colic will be recruited by NHS health visitors. Infants will be included into the study if they are healthy (full-term) and aged 1-7 weeks, diagnosed with excessive crying/infantile colic, and have no co-morbidities. Participants will be randomised into the usual NHS care group or the usual NHS care plus cranial osteopathic intervention group.

Usual NHS care will be provided by health visitors and osteopathic treatment will be carried out by experienced osteopaths in private practice.

Primary outcome measures are acceptability and feasibility of intervention procedures. Furthermore, changes in the frequency and duration of crying will be documented in a daily crying diary. Parental quality of life will also be assessed.

This pilot investigation will provide useful information in order to further develop and adapt the current interventions and trial procedures with a view to a full-scale randomised controlled trial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-16
• Study Start: 2014-06
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-20
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• healthy, diagnosed with excessive crying by NHS Health Visitors No comorbidities Parents are able to adequately communicate in English

Exclusion Criteria

• Currently participating in other therapeutic clinical trials Currently receive manual therapy treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual NHS care	Usual NHS Care	-
Usual NHS Care plus Osteopathic Manipulative Therapy	Usual NHS Care	-
Usual NHS Care plus Osteopathic Manipulative Therapy	Osteopathic Manipulative Therapy	-

Primary Outcome Measures

Name	Time	Method
Change in daily hours crying time	4 weeks

Secondary Outcome Measures

Name	Time	Method
Parental Quality of life	4 weeks

Trial Locations

Locations (1)

European School of Osteopathy; 🇬🇧 Maidstone, Kent, United Kingdom