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

<p>Abstract</p> <p>Background</p> <p>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, i...

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Main Authors: Modesto Manuela, Perea-Milla Emilio, Méndez Camila, Campos M Ángeles, Aguilar Inmaculada, Vas Jorge, Caro Paloma, Martos Francisco, García-Ruiz Antonio J
Format: Article
Language:English
Published: BMC 2008-07-01
Series:BMC Complementary and Alternative Medicine
Online Access:http://www.biomedcentral.com/1472-6882/8/36
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author Modesto Manuela
Perea-Milla Emilio
Méndez Camila
Campos M Ángeles
Aguilar Inmaculada
Vas Jorge
Caro Paloma
Martos Francisco
García-Ruiz Antonio J
author_facet Modesto Manuela
Perea-Milla Emilio
Méndez Camila
Campos M Ángeles
Aguilar Inmaculada
Vas Jorge
Caro Paloma
Martos Francisco
García-Ruiz Antonio J
author_sort Modesto Manuela
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN01897462.</p>
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spelling doaj.art-7793f5cc9b644a4085be2f0839578caf2022-12-22T01:22:04ZengBMCBMC Complementary and Alternative Medicine1472-68822008-07-01813610.1186/1472-6882-8-36Randomised controlled study in the primary healthcare sector to investigate the effectiveness and safety of auriculotherapy for the treatment of uncomplicated chronic rachialgia: a study protocolModesto ManuelaPerea-Milla EmilioMéndez CamilaCampos M ÁngelesAguilar InmaculadaVas JorgeCaro PalomaMartos FranciscoGarcía-Ruiz Antonio J<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN01897462.</p>http://www.biomedcentral.com/1472-6882/8/36
spellingShingle Modesto Manuela
Perea-Milla Emilio
Méndez Camila
Campos M Ángeles
Aguilar Inmaculada
Vas Jorge
Caro Paloma
Martos Francisco
García-Ruiz Antonio J
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
BMC Complementary and Alternative Medicine
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url http://www.biomedcentral.com/1472-6882/8/36
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