Cranial Osteopathy in Infantile Colic
Cranial Osteopathic Manipulative Therapy in Addition to Usual Care in Excessively Crying Infants, Sometimes Called Colic
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2013
CompletedFirst Posted
Study publicly available on registry
September 16, 2013
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedFebruary 20, 2015
February 1, 2015
2.5 years
September 11, 2013
February 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in daily hours crying time
4 weeks
Secondary Outcomes (1)
Parental Quality of life
4 weeks
Study Arms (2)
Usual NHS care
ACTIVE COMPARATORUsual NHS Care plus Osteopathic Manipulative Therapy
ACTIVE COMPARATORInterventions
Usual NHS care is provided by a health visitor who will diagnose excessively crying infants/infants with colic in the first instance. Parents usually will then have the opportunity to consult their health visitor when needed. The health visitor will provide support and advice on how to manage the condition within their professional remit.
Osteopathic treatment will be provided by experienced osteopaths once a week for up to four weeks, depending on needs. Treatment will be individualised, according to clinical findings, and involves using standard cranial osteopathic techniques. All parents will be able to ask questions.
Eligibility Criteria
You may qualify if:
- healthy, diagnosed with excessive crying by NHS Health Visitors No comorbidities Parents are able to adequately communicate in English
You may not qualify if:
- Currently participating in other therapeutic clinical trials Currently receive manual therapy treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- European School of Osteopathylead
- Sutherland Cranial College of Osteopathycollaborator
- Sutherland Societycollaborator
Study Sites (1)
European School of Osteopathy
Maidstone, Kent, ME14 3DZ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2013
First Posted
September 16, 2013
Study Start
June 1, 2014
Primary Completion
December 1, 2016
Last Updated
February 20, 2015
Record last verified: 2015-02