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Title: Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine.
Authors: Vas, Jorge
Rebollo, Angel
Perea-Milla, Emilio
Méndez, Camila
Font, Carlos Ramos
Gómez-Río, Manuel
Martín-Avila, Manuel
Carbrera-Iboleón, Justo
Caballero, M Dolores
Olmos, M Angeles
Aguilar, Inmaculada
Faus, Vicente
Martos, Francisco
metadata.dc.contributor.authoraffiliation: [Vas,J; Aguilar,I] Pain Treatment Unit, Primary Healthcare Centre, Dos Hermanas, Spain. [Rebollo,A; Ramos Font,E; Gómez-Río,M] Service of Nuclear Medicine, Virgen de las Nieves Hospital, Granada, Spain. [Perea-Milla,E] Support Research Unit (Network and Cooperative Research Centers of Epidemiology. CIBERESP); y [Faus,V] Service of Pharmacology, Costa del Sol Hospital, Marbella, Spain. [Méndez,C] Andalusian Public Health System, Sevilla, Spain. [Martín-Avila,M] Armilla Primary Care Center, Granada, Spain. [Carbrera-Iboleón,J] Valle de Lecrin Primary Care Center, Granada, Spain. [Caballero,MD] Pain Clinic, Virgen de las Nieves Hospital, Granada, Spain. [Olmos,MA] Ugijar Primary Care Center, Granada, Spain. [Martos,M] Department of Pharmacology, Malaga University, Spain
Keywords: Terapia por acupuntura;Trastornos migrañosos;Calidad de vida;Atención primaria
metadata.dc.subject.mesh: Medical Subject Headings::Named Groups::Persons::Age Groups::Adult
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Double-Blind Method
Medical Subject Headings::Check Tags::Female
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Check Tags::Male
Medical Subject Headings::Diseases::Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Headache Disorders::Headache Disorders, Primary::Migraine Disorders
Medical Subject Headings::Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Epidemiologic Factors::Effect Modifier, Epidemiologic::Placebo Effect
Medical Subject Headings::Health Care::Health Services Administration::Patient Care Management::Comprehensive Health Care::Primary Health Care
Medical Subject Headings::Disciplines and Occupations::Social Sciences::Quality of Life
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Methods::Research Design
Medical Subject Headings::Geographicals::Geographic Locations::Europe::Spain
Medical Subject Headings::Health Care::Health Services Administration::Quality of Health Care::Outcome and Process Assessment (Health Care)::Outcome Assessment (Health Care)::Treatment Outcome
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Complementary Therapies::Acupuncture Therapy
Issue Date: 2008
Publisher: BioMed Central
Citation: Vas J, Rebollo A, Perea-Milla E, Méndez C, Ramos Font C, Gómez-Río M, et al. Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine. BMC Complement Altern Med; 8:12
Abstract: BACKGROUND Migraine is a chronic neurologic disease that can severely affect the patient's quality of life. Although in recent years many randomised studies have been carried out to investigate the effectiveness of acupuncture as a treatment for migraine, it remains a controversial issue. Our aim is to determine whether acupuncture, applied under real conditions of clinical practice in the area of primary healthcare, is more effective than conventional treatment. METHODS/DESIGN The design consists of a pragmatic multi-centre, three-armed randomised controlled trial, complemented with an economic evaluation of the results achieved, comparing the effectiveness of verum acupuncture with sham acupuncture, and with a control group receiving normal care only. Patients eligible for inclusion will be those presenting in general practice with migraine and for whom their General Practitioner (GP) is considering referral for acupuncture. Sampling will be by consecutive selection, and by randomised allocation to the three branches of the study, in a centralised way following a 1:1:1 distribution (verum acupuncture; sham acupuncture; conventional treatment). Secondly, one patient in three will be randomly selected from each of the acupuncture (verum or sham) groups for a brain perfusion study (by single photon emission tomography). The treatment with verum acupuncture will consist of 8 treatment sessions, once a week, at points selected individually by the acupuncturist. The sham acupuncture group will receive 8 sessions, one per week, with treatment being applied at non-acupuncture points in the dorsal and lumbar regions, using the minimal puncture technique. The control group will be given conventional treatment, as will the other two groups. DISCUSSION This trial will contribute to available evidence on acupuncture for the treatment of migraine. The primary endpoint is the difference in the number of days with migraine among the three groups, between the baseline period (the 4 weeks prior to the start of treatment) and the period from weeks 9 to 12. As a secondary aspect, we shall record the index of laterality and the percentage of change in the mean count per pixel in each region of interest measured by the brain perfusion tomography, performed on a subsample of the patients within the real and sham acupuncture groups. TRIAL REGISTRATION Current Controlled Trials ISRCTN98703707.
Description: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't;
metadata.dc.identifier.doi: 10.1186/1472-6882-8-12
ISSN: 1472-6882 (Online)
Appears in Collections:01- Artículos - AGS Sur de Granada
01- Artículos - APES Costa del Sol
01- Artículos - DAP Metropolitano de Granada
01- Artículos - DSAP Sevilla Sur
01- Artículos - Hospital Virgen de las Nieves
01- Artículos - Servicio Andaluz de Salud

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