Context: Cranial osteopathic manipulative medicine (OMM) involves the manipulation of the primary respiratory mechanism to improve structure and function in children and adults.
Objective: To identify and critically evaluate the literature regarding the clinical efficacy of cranial OMM.
Data sources: The clinical keywords "cranial manipulation" OR "osteopathy in the cranial field" OR "cranial osteopathy" OR "craniosacral technique" were searched in the following electronic databases: EMBASE, MEDLINE In-Process & Other Non-Indexed Citations, The Cochrane Central Register of Controlled Trials, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and AMED (Alternative Medicine). Searches were conducted in April 2011 with no date restriction for when the studies were completed.
Study selection: Randomized controlled trials and observational studies that measured the effectiveness of cranial OMM on humans were included in the study. Exclusion criteria included non-English language articles, studies not relevant to cranial OMM, animal studies, and studies in which there was no clear indication of the use of cranial OMM. Studies that described the use of cranial OMM with other treatment modalities and that did not perform subgroup analysis were also excluded. The present study did not have criteria regarding type of disease.
Data extraction: Outcome measures on pain, sleep, quality of life, motor function, and autonomic nervous system function were extracted. The methodological quality of the trials was assessed using the Downs and Black checklist.
Data synthesis: Of the 8 studies that met the inclusion criteria, 7 were randomized controlled trials and 1 was an observational study. A range of cranial OMM techniques used for the management of a variety of conditions were identified in the included studies. Positive clinical outcomes were reported for pain reduction, change in autonomic nervous system function, and improvement of sleeping patterns. Methodological Downs and Black quality scores ranged from 14 to 23 points out of a maximum of 27 points (overall median score, 16).
Conclusion: The currently available evidence on the clinical efficacy of cranial OMM is heterogeneous and insufficient to draw definitive conclusions. Because of the moderate methodological quality of the studies and scarcity of available data, further research into this area is needed.