Objectives To estimate the effect of cranial osteopathy on the general health and wellbeing, including physical functioning, of children with cerebral palsy.
Design Pragmatic randomised controlled trial.
Participants 142 children from Greater London and the South West of England, aged 5–12 years with cerebral palsy.
Intervention Participants were randomised to six sessions of cranial osteopathy with a registered osteopath or a waiting list with partial attention control (parents invited to participate in two semistructured interviews).
Primary outcome measures Blind assessment of motor function by physiotherapists using the Gross Motor Function Measure-66 (GMFM-66) and quality of life using the Child Health Questionnaire (CHQ) PF50 at 6 months.
Secondary outcome measures Parents' assessment of global health and sleep at 6 months, pain and sleep diaries at 10 weeks and 6 months, CHQ PF50 at 10 weeks and quality of life of main carer (Short Form 36) at 10 weeks and 6 months.
Results Compared with children in the control group, children in the osteopathy group demonstrated no statistically significant differences in GMFM-66 (mean difference 4.9, 95% CI −4.4 to 14.1), CHQ Physical Summary Score (mean difference 2.2, 95% CI −3.5 to 8.0) or CHQ Psychological Summary Score (mean difference 3.4, 95% CI −0.8 to 7.7). There were no significant differences between groups with respect to pain; sleep (either ‘time asleep’ or ‘time to sleep’); or main carer's quality of life.
Compared with children in the control group, carers of children receiving cranial osteopathy were nearly twice as likely to report that their child's global health had ‘improved’ at 6 months rather than ‘decreased’ or ‘remained the same’ (38% vs 18%; odds ratio 2.8, 95% CI 1.1 to 6.9).
Conclusions This trial found no statistically significant evidence that cranial osteopathy leads to sustained improvement in motor function, pain, sleep or quality of life in children aged 5–12 years with cerebral palsy nor in quality of life of their carers.
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Funding The study was funded by Cerebra. The funder monitored the trial progress through a trial steering committee chaired by Professor Alan Emond. Trial data were monitored by a data monitoring committee subgroup chaired by Dr Paul Ewings. The funders had no part in the design of the study; the collection, analysis, and interpretation of the data; the writing of the report; and the decision to submit the article for publication. SL, NB, KW and VE were also partially supported by the National Institute for Health Research (NIHR) PenCLAHRC. The study sponsor was the Royal Devon and Exeter Hospital.
Competing interests None.
Ethical approval The study was approved by Southwest Research Ethics Committee (06/MRE06/1) in April 2007. The parents/legal guardians of all children enrolled gave their informed consent for their child to participate.
Provenance and peer review Not commissioned; externally peer reviewed.