Moxibustion

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Study protocol

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Correcting non cephalic presentation with moxibustion: study protocol for a multi-centre randomised controlled trial in general practice
Jorge Vas*1, José Manuel Aranda2, Mercedes Barón3, Emilio Perea-Milla4, Camila Méndez5, Carmen Ramírez6, Inmaculada Aguilar1, Manuela Modesto1, Ana María Lara7,Francisco Martos8 and Antonio J García-Ruiz8
Address: 1Pain Treatment Unit, Primary Healthcare Centre, Dos Hermanas, Spain, 2San Andrés-Torcal Primary Healthcare Centre, Málaga, Spain, 3El Lugar Primary Healthcare Centre, Chiclana de la Frontera, Spain, 4Support Research Unit (Network and Cooperative Research Centres of Epidemiology. CIBERESP), Costa del Sol Hospital, Marbella, Spain, 5AndalusianPublic Health System, Sevilla, Spain, 6Doña Mercedes Primary Healthcare Centre, Dos Hermanas, Spain, 7Gonzalo Bilbao, Primary Healthcare Centre, Sevilla, Spain and 8Department of Pharmacology, Malaga University, Spain Email: Jorge Vas* - jorgef.vas.sspa@juntadeandalucia.es; José Manuel Aranda - regules@samfyc.es; Mercedes Barón - merbaron@terra.es; Emilio Perea-Milla - eperea@hcs.es; Camila Méndez -camila.mendez@juntadeandalucia.es; Carmen Ramírez - maracaquince@yahoo.es; Inmaculada Aguilar - iaguilar42@mixmail.com; Manuela Modesto - manumodelop@hotmail.com; Ana María Lara - amlara57@hotmail.com; Francisco Martos - fmartos@uma.es; Antonio J García-Ruiz - ajgr@uma.es * Corresponding author

Published: 21 May 2008 BMC Complementary and Alternative Medicine 2008, 8:22doi:10.1186/1472-6882-8-22

Received: 5 May 2008 Accepted: 21 May 2008

This article is available from: http://www.biomedcentral.com/1472-6882/8/22 © 2008 Vas et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in anymedium, provided the original work is properly cited.

Abstract
Background: Non cephalic presentation in childbirth involves various risks to both the mother and the foetus. The incidence in Spain is 3.8% of all full-term pregnancies. The most common technique used to end the gestation in cases of non cephalic presentation is that of caesarian section, and although it provokes a lower rate ofmorbi-mortality than does vaginal delivery in such situations, there remains the possibility of traumatic injury to the foetal head and neck, while maternal morbidity is also increased. The application of heat (moxibustion) to an acupuncture point, in order to correct non cephalic presentation, has been practised in China since ancient times, but as yet there is insufficient evidence of its realeffectiveness. Methods/Design: The experimental design consists of a multi-centre randomised controlled trial with three parallel arms, used to compare real moxibustion, sham moxibustion and the natural course of events, among pregnant women with a non cephalic presentation and a gestational duration of 33–35 weeks (estimated by echography). The participants in the trial will be blinded to bothinterventions. The results obtained will be analyzed by professionals, blinded with respect to the allocation to the different types of intervention. In addition, we intend to carry out a economic analysis. Discussion: This trial will contribute to the development of evidence concerning moxibustion in the correction of non cephalic presentations. The primary outcome variable is the proportion of cephalicpresentations at term. As secondary outcomes, we will evaluate the proportion of cephalic presentations at week 38 of gestation, determined by echography, together with the safety of the technique, the specificity of moxibustion and the control of the blinding process. This study has been funded by the Health Ministry of the Andalusian Regional Government. Trial registration: Current Controlled...