SAS - D.S.A.P. Sevilla Sur

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  • Publication
    Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine.
    (BioMed Central, 2008) 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; [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
    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.
  • Publication
    Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial protocol [ISRCTN65814467]
    (BioMed Central, 2006-04-21) Vas, Jorge; Perea-Milla, Emilio; Mendez, Camila; Silva, Luis Carlos; Herrera Galante, Antonia; Aranda Regules, Jose Manuel; Martinez Barquin, Dulce M; Aguilar, Inmaculada; Faus, Vicente; [Vas,J; Aguilar,I] Unidad de Tratamiento del Dolor, Centro de Salud Dos Hermanas "A", Dos Hermanas, Spain. [Perea-Milla,E] Unidad de Apoyo a la Investigación (Red IRYSS) y [Faus,V] Servicio de Farmacia, Hospital Costa del Sol, Marbella. [Mendez,C] Servicio Protección Civil, Delegación de Gobierno, Cádiz, España. [Silva,LC] Departamento de Investigaciones, INFOMED, Ciudad de la Habana, Cuba. [Herrera Galante,A] Servicio de Rehabilitación, Complejo Hospitalario Carlos Haya, Málaga, Spain. [Aranda Regules,JM] Centro de Salud San Andrés-Torcal, Málaga, Spain. [Martinez Barquin,DM] Unidad de Tratamiento del Dolor. Distrito Sanitario, Málaga, Spain.; The study protocol was developed in 2004 and is funded by the Ministerio de Salud y Consumo – Instituto de Salud Carlos III (File No. PI051191).
    BACKGROUND Low back pain and its associated incapacitating effects constitute an important healthcare and socioeconomic problem, as well as being one of the main causes of disability among adults of working age. The prevalence of non-specific low back pain is very high among the general population, and 60-70% of adults are believed to have suffered this problem at some time. Nevertheless, few randomised clinical trials have been made of the efficacy and efficiency of acupuncture with respect to acute low back pain. The present study is intended to assess the efficacy of acupuncture for acute low back pain in terms of the improvement reported on the Roland Morris Questionnaire (RMQ) on low back pain incapacity, to estimate the specific and non-specific effects produced by the technique, and to carry out a cost-effectiveness analysis. METHODS/DESIGN Randomised four-branch controlled multicentre prospective study made to compare semi-standardised real acupuncture, sham acupuncture (acupuncture at non-specific points), placebo acupuncture and conventional treatment. The patients are blinded to the real, sham and placebo acupuncture treatments. Patients in the sample present symptoms of non specific acute low back pain, with a case history of 2 weeks or less, and will be selected from working-age patients, whether in paid employment or not, referred by General Practitioners from Primary Healthcare Clinics to the four clinics participating in this study. In order to assess the primary and secondary result measures, the patients will be requested to fill in a questionnaire before the randomisation and again at 3, 12 and 48 weeks after starting the treatment. The primary result measure will be the clinical relevant improvement (CRI) at 3 weeks after randomisation. We define CRI as a reduction of 35% or more in the RMQ results. DISCUSSION This study is intended to obtain further evidence on the effectiveness of acupuncture on acute low back pain and to isolate the specific and non-specific effects of the treatment.
  • Publication
    Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220]
    (BioMed Central, 2005-10-14) Vas, Jorge; Perea-Milla, Emilio; Mendez, Camila; Galante, Antonia Herrera; Madrazo, Fernando; Medina, Ivan; Ortega, Caridad; Olmo, Victoria; Perez Fernandez, Francisco; Hernandez, Luz; Seminario, Jose Maria; Brioso, Mauricio; Luna, Francisco; Gordo, Isabel; Godoy, Ana Maria; Jimenez, Carmen; Ruiz, Manuel Anselmo; Montes, Joaquin; Hidalgo, Alonso; Gonzalez-Quevedo, Rosa; Bosch, Pablo; Vazquez, Antonio; Lozano, Juan Vicente; [Vas,J; Brioso,M] Unidad de Tratamiento del Dolor, Centro de Salud Dos Hermanas "A", Dos Hermanas, Spain. [Perea-Milla,E] Unidad de Apoyo a la Investigación (Red IRYSS), Hospital Costa del Sol, Marbella, Spain. [Mendez,C] Servicio de Coordinación de Procesos Asistenciales, Subdirección Asistencial. Servicio Andaluz de Salud, Sevilla, Spain. [Herrera Galante,A; Medina,I; Godoy,AM] Servicio de Rehabilitación, Complejo Hospitalario Carlos Haya, Málaga Spain. [Madrazo,F; Montes,J; Hidalgo,A; Gonzalez-Quevedo,R; Bosch,P;Vazquez,A] Servicio de Rehabilitación, Hospital Valme, Sevilla Spain. [Ortega,C; Jimenez,C] Servicio de Rehabilitación, Hospital Infanta Elena, Huelva Spain. [Olmo,V; Ruiz,MA] Servicio de Rehabilitación, Hospital Infanta Margarita, Cabra, Spain. [Perez Fernandez,F; Hernandez,L] Servicio de Rehabilitación, Hospital General Básico de la Defensa, Cartagena. [Seminario,JM] Servicio de Anestesia y Reanimación; y [Luna,F; Gordo,I] Servicio de Rehabilitación, Hospital Serranía, Ronda. [Lozano,JV] Servicio de Rehabilitación, Hospital Morales Meseguer, Murcia.; The study protocol was developed in 2004 and is cofunded by Fundación Progreso y Salud (File No. 82045) from the recruitment phase until the short term evaluation, and by Consejeria de Salud de la Junta de Andalucia (File No. 136/04) for the long term follow up phases. The publishing of this article is funded by the IRYSS Network.
    BACKGROUND Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). METHODS/DESIGN Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). The patients will be randomised into two groups: 1) experimental (acupuncture + physiotherapy); 2) control (TENS-placebo + physiotherapy); the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA) Scale; as secondary variables, we will record the changes in diurnal pain intensity on a visual analogue scale (VAS), nocturnal pain intensity on the VAS, doses of non-steroid anti-inflammatory drugs (NSAIDs) taken during the study period, credibility scale for the treatment, degree of improvement perceived by the patient and degree of improvement perceived by the evaluator. A follow up examination will be made at 3, 6 and 12 months after the study period has ended. Two types of population will be considered for analysis: per protocol and per intention to treat. DISCUSSION The discussion will take into account the limitations of the study, together with considerations such as the choice of a simple, safe method to treat this shoulder complaint, the choice of the control group, and the blinding of the patients, evaluators and those responsible for carrying out the final analysis.
  • Publication
    Correcting non cephalic presentation with moxibustion: study protocol for a multi-centre randomised controlled trial in general practice.
    (BioMed Central, 2008-05-21) Vas, Jorge; Aranda, José Manuel; Barón, Mercedes; Perea-Milla, Emilio; Méndez, Camila; Ramírez, Carmen; Aguilar, Inmaculada; Modesto, Manuela; Lara, Ana María; Martos, Francisco; García-Ruiz, Antonio J; [Vas,J; Aguilar,I; Modesto,M] Pain Treatment Unit, Primary Healthcare Centre, Dos Hermanas, Spain. [Aranda,JM] San Andrés-Torcal Primary Healthcare Centre, Málaga, Spain. [Barón,M] El Lugar Primary Healthcare Centre, Chiclana de la Frontera, Spain. [Perea-Milla,E] Support Research Unit (Network and Cooperative Research Centres of Epidemiology CIBERESP), Costa del Sol Hospital, Marbella, Spain. [Méndez,C] Andalusian Public Health System, Sevilla, Spain. [Ramírez,C] Doña Mercedes Primary Healthcare Centre, Dos Hermanas, Spain. [Lara,AM] Gonzalo Bilbao, Primary Healthcare Centre, Sevilla, Spain. [Martos,F; García-Ruiz,AJ] Department of Pharmacology, Malaga University, Spain.
    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 of morbi-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 real effectiveness. 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 both interventions. 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 cephalic presentations 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 Trials ISRCTN10634508.
  • Publication
    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.
    (BioMed Central, 2008) Vas, Jorge; Aguilar, Inmaculada; Campos, M Ángeles; Méndez, Camila; Perea-Milla, Emilio; Modesto, Manuela; Caro, Paloma; Martos, Francisco; García-Ruiz, Antonio J; [Vas,J; Aguilar,I; Campos,MA; Modesto,M] Pain Treatment Unit, Primary Healthcare Centre, Dos Hermanas, Spain. [Méndez,C] Andalusian Public Health System, Sevilla, Spain. [Perea-Milla,E] Support Research Unit (Public Health and Epidemiology Network Biomedical Research Centre. CIBERESP), Costa del Sol Hospital, Marbella, Spain. [Caro,P] Doña Mercedes Primary Healthcare Centre, Dos Hermanas, Spain. [García-Ruiz,AJ] Department of Pharmacology, Malaga University, Spain; This study has obtained a grant (No. 07/90058) in a competitive application process of the programme for promoting non-commercial clinical research in the fields of biomedicine and healthcare science, organized by the Spanish Ministry of Health and Consumer Affairs (Carlos III Health Institute). It has obtained another grant (No. 0046/2007), also in a competitive application process, from the programme run by the Andalusian Public Health System for promoting biomedical and healthcare science research to carry out clinical research projects.
    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.
  • Publication
    Brote de brucelosis interprovincial por ingesta de queso fresco sin higienizar
    (Sociedad Andaluza de Medicina Familiar y Comunitaria, 2007) Barroso García, P; Lucerna Méndez, Mª A; Cortés Majo, M; Toranzo Luna, M; Escabias Machuca, FJ; Molina Cano, F; [Barroso García,P] Sección de Epidemiología. Distrito Sanitario de Atención Primaria Levante-Alto Almanzora, Almería. [Lucerna Méndez, MA] Servicio de Prevención. Hospital de Poniente, Almería. [Cortés Majo,M] Sección de Epidemiología. Distrito Sanitario Sevilla Sur. [Toranzo Luna,M; Escabias Machuca,FJ; Molina Cano,F] Centro de Salud de Vélez-Rubio. Zona Básica de Salud de los Vélez.
    Objetivo: Investigar un brote de brucelosis declarado en agosto de 2004 en Vélez-Rubio (Almería), para determinar fuente de infección, mecanismo de transmisión y proponer medidas de prevención. Diseño: Estudio descriptivo y de casos-controles apareados (se seleccionaron tres controles por caso). Emplazamiento: Centros de Salud de Vélez-Rubio y Alcalá de Guadaira. Población: Caso sospechoso/probable: persona con clínica compatible y aglutinación a Brucella positiva, diagnosticado entre julio de 2004 y marzo de 2005; caso confirmado: cuando además se identificó agente causal o comprobó seroconversión. Intervenciones: Como fuentes de información se utilizaron fichas de declaración de enfermedad, encuestas epidemiológicas, historias clínicas e información microbiológica. Se calcularon odds ratio (OR) e intervalos de confianza para estudiar relación entre casos, fuente de infección y mecanismos de transmisión. Se utilizó el test de Chi-cuadrado y corrección de Yates. Resultados: Se identificaron 10 casos (9 en Almería y 1 en Sevilla), 8 probables y 2 confirmados; con edades entre 45 y 81 años. Los síntomas se iniciaron entre mayo y septiembre de 2004. El más frecuente fue fiebre (100%). La OR para ingesta de queso fresco sin higienizar fue de 112 (IC 4,48-16968,94), p< 0,001. Se intervino el ganado fuente de infección. Conclusiones: Se confirmó brote de brucelosis interprovincial por el consumo de queso fresco sin higienizar procedente de venta ambulante. Se identificó la fuente de infección y se realizaron actuaciones por parte de Agricultura.
  • Publication
    Mejora en el uso de tiras para autoanálisis de glucemia capilar
    (Servicio Andaluz de Salud, 2013-06) Unidad de gestión clínica de Farmacia de Atención Primaria de Sevilla; Distritos de Atención Primaria Sevilla, Aljarafe-Norte y Sevilla Sur.
    Objetivos. Adecuar el uso de las tiras de glucemia para autoanálisis del paciente diabético a criterios de uso adecuado, basadas en evidencias.
  • Publication
    Mitochondrial dysfunction and mitophagy activation in blood mononuclear cells of fibromyalgia patients: implications in the pathogenesis of the disease.
    (BioMed Central, 2010-01-28) Cordero, Mario D.; De Miguel, Manuel; Moreno Fernández, Ana M.; Carmona López, Inés M.; Garrido Maraver, Juan; Cotán, David.; Gómez-Izquierdo, Lourdes; Bonal, Pablo; Campa, Francisco; Bullon, Pedro; Navas, Plácido; Sánchez Alcázar, José A.; [Cordero,MD; Garrido Maraver,J; Cotán,D; Navas,P; Sánchez Alcázar,JA] Centro Andaluz de Biología del Desarrollo (CABD), Universidad Pablo de Olavide-CSIC, ISCIII, Sevilla, Spain. [Cordero,MD; Garrido Maraver,J; Cotán,D; Navas,P; Sánchez Alcázar,JA] Centro de Investigación Biomédica en Red de Enfermedades Raras (CIBERER), Universidad Pablo de Olavide-CSIC, ISCIII, Sevilla, Spain. [Cordero,MD; De Miguel,M; Moreno Fernández,AM; Carmona López,IM.] Dpto. Citología e Histología Normal y Patológica, Facultad de Medicina. Universidad de Sevilla, Sevilla, Spain. [Gómez-Izquierdo,L] Departamento de Anatomía Patológica. Hospital Virgen del Rocío, Sevilla, Spain. [Bonal,P; Campa,F] Dpto. de Medicina, Facultad de Medicina. Universidad de Sevilla, Sevilla, Spain. [Campa,F] Distrito Sanitario Sevilla Sur. Facultad de Odontología, Universidad de Sevilla, Sevilla, Spain. [Bullon,P] Departamento de Periodontología, Facultad de Odontología, Universidad de Sevilla, Sevilla, Spain; This work was supported by grants FIS PI080500 and FIS EC08/00076, Ministerio de Sanidad, Spain.
    Introduction. Fibromyalgia is a chronic pain syndrome with unknown etiology. Recent studies have shown some evidence demonstrating that oxidative stress may have a role in the pathophysiology of fibromyalgia. However, it is still not clear whether oxidative stress is the cause or the effect of the abnormalities documented in fibromyalgia. Furthermore, the role of mitochondria in the redox imbalance reported in fibromyalgia also is controversial. We undertook this study to investigate the role of mitochondrial dysfunction, oxidative stress, and mitophagy in fibromyalgia. Methods. We studied 20 patients (2 male, 18 female patients) from the database of the Sevillian Fibromyalgia Association and 10 healthy controls. We evaluated mitochondrial function in blood mononuclear cells from fibromyalgia patients measuring, coenzyme Q10 levels with high-performance liquid chromatography (HPLC), and mitochondrial membrane potential with flow cytometry. Oxidative stress was determined by measuring mitochondrial superoxide production with MitoSOX™ and lipid peroxidation in blood mononuclear cells and plasma from fibromyalgia patients. Autophagy activation was evaluated by quantifying the fluorescence intensity of LysoTracker™ Red staining of blood mononuclear cells. Mitophagy was confirmed by measuring citrate synthase activity and electron microscopy examination of blood mononuclear cells. Results. We found reduced levels of coenzyme Q10, decreased mitochondrial membrane potential, increased levels of mitochondrial superoxide in blood mononuclear cells, and increased levels of lipid peroxidation in both blood mononuclear cells and plasma from fibromyalgia patients. Mitochondrial dysfunction was also associated with increased expression of autophagic genes and the elimination of dysfunctional mitochondria with mitophagy. Conclusions. These findings may support the role of oxidative stress and mitophagy in the pathophysiology of fibromyalgia.