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

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

²Andalusian Public Health System, Sevilla, Spain

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

⁴Doña Mercedes Primary Healthcare Centre, Dos Hermanas, Spain

⁵Department of Pharmacology, Malaga University, Spain

author email corresponding author email

BMC Complementary and Alternative Medicine 2008, 8:36doi: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.