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Open Access Study protocol

Randomised controlled study in the primary healthcare sector to investigate the effectiveness and safety of auriculotherapy for the treatment of uncomplicated chronic rachialgia: a study protocol

Jorge Vas1*, Inmaculada Aguilar1, M Ángeles Campos1, Camila Méndez2, Emilio Perea-Milla3, Manuela Modesto1, Paloma Caro4, Francisco Martos5 and Antonio J García-Ruiz5

Author Affiliations

1 Pain Treatment Unit, Primary Healthcare Centre, Dos Hermanas, Spain

2 Andalusian Public Health System, Sevilla, Spain

3 Support Research Unit (Public Health and Epidemiology Network Biomedical Research Centre. CIBERESP), Costa del Sol Hospital, Marbella, Spain

4 Doña Mercedes Primary Healthcare Centre, Dos Hermanas, Spain

5 Department of Pharmacology, Malaga University, Spain

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BMC Complementary and Alternative Medicine 2008, 8:36  doi:10.1186/1472-6882-8-36

Published: 6 July 2008

Abstract

Background

Uncomplicated chronic rachialgia is a highly prevalent complaint, and one for which therapeutic results are contradictory. The aim of the present study is to evaluate the effectiveness and safety of treatment with auriculopressure, in the primary healthcare sector, carried out by trained healthcare professionals via a 30-hour course.

Methods/Design

The design consists of a multi-centre randomized controlled trial, with placebo, with two parallel groups, and including an economic evaluation. Patients with chronic uncomplicated rachialgia, whose GP is considering referral for auriculopressure sensory stimulation, are eligible for inclusion. Sampling will be by consecutive selection, and randomised allocation to one of the two study arms will be determined using a centralised method, following a 1:1 plan (true auriculopressure; placebo auriculopressure). The implants (true and placebo) will be replaced once weekly, and the treatment will have a duration of 8 weeks. The primary outcome measure will be the change in pain intensity, measured on a visual analogue scale (VAS) of 100 mm, at 9 weeks after beginning the treatment. A follow up study will be performed at 6 months after beginning treatment. An assessment will also be made of the changes measured in the Spanish version of the McGill Pain Questionnaire, of the changes in the Lattinen test, and of the changes in quality of life (SF-12). Also planned is an analysis of cost-effectiveness and also, if necessary, a cost-benefit analysis.

Discussion

This study will contribute to developing evidence on the use of auriculotherapy using Semen vaccariae [wang bu liu xing] for the treatment of uncomplicated chronic rachialgia.

Trial registration

Current Controlled Trials ISRCTN01897462.