Cranial osteopathy for children with cerebral palsy: a randomised controlled trial
- Katrina Wyatt1,
- Vanessa Edwards1,
- Linda Franck2,
- Nicky Britten1,
- Siobhan Creanor3,
- Andrew Maddick4,
- Stuart Logan1
- 1Peninsula College of Medicine and Dentistry, University of Exeter, Exeter, UK
- 2Department of Family Health Care Nursing University of California, San Francisco, USA
- 3Centre for Health & Environmental Statistics, University of Plymouth, Plymouth, UK
- 4Foundation for Paediatric Osteopathy, London, UK
- Correspondence to Professor Stuart Logan, Peninsula Medical School, Veysey Building, Salmon Pool Lane, Exeter, EX2 4SG, UK; stuart.logan{at}pms.ac.uk
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Contributors SL, NB and VE were applicants on the original grant to the Cerebra Foundation. SL, NB, LF and VE wrote the protocol and VE applied for Ethical and Research Governance approval. VE was trial manager, and together with KW, SL and LF supervised the research and clerical assistants, CL, CM and BA, who visited families, collected and imported data. VE, CL and CM set up the database. NB supervised the qualitative aspects of the trial. AM oversaw the osteopathic aspect of the trial. VE supervised the data cleaning carried out by CL and CM. SC did the final analysis. KW, VE and SL drafted the paper which was commented on by the other authors. SL is the guarantor. All authors had full access to the data (including statistical reports and tables) in the trial and can take responsibility for the integrity of the data and the accuracy of the data analysis.
- Accepted 18 January 2011
- Published Online First 24 February 2011
Abstract
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.
Trial Registration ISRCTN45840554 http://www.controlled-trials.com
Footnotes
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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.
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Competing interests None.
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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.
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Provenance and peer review Not commissioned; externally peer reviewed.
