Infantile Colic Clinical Trial
Official title:
Cranial Osteopathic Manipulative Therapy in Addition to Usual Care in Excessively Crying Infants, Sometimes Called Colic
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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