Cranial Osteopathy in Infantile Colic

European School of Osteopathy

Status: Unknown

Conditions: Infantile Colic

Treatments: Other: Osteopathic Manipulative Therapy; Other: Usual NHS Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01942928

ESO-001-2013 (Other Identifier)

ESO-001-colic

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 7 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Usual NHS care

Active Comparator group

Treatment:

Other: Usual NHS Care

Usual NHS Care plus Osteopathic Manipulative Therapy

Active Comparator group

Treatment:

Other: Usual NHS Care

Other: Osteopathic Manipulative Therapy