Effectiveness of a multidisciplinary BIOPSYCHOSOCIAL intervention for non-specific SUBACUTE low back pain in a working population: a cluster randomized clinical trial.

BACKGROUND: Low back pain (LBP) is a multifactorial condition with individual and societal impact that affects populations globally. Current guidelines for the treatment of LBP recommend pharmacological and non-pharmacological strategies. The aim of this study was to compare usual clinical practice with the effectiveness of a biopsychosocial multidisciplinary intervention in reducing disability, severity of pain and improving quality of life in a working population of patients with subacute (2-12 weeks), non-specific LBP. METHODS: Longitudinal cluster randomized clinical trial conducted in 39 Primary Health Care Centres (PHCC) of Barcelona, with patients aged 18-65 years (n = 501; control group = 239; 26 PHCC, intervention group = 262; 13 PHCC). The control group received usual clinical care. The intervention group received usual clinical care plus a biopsychosocial multidisciplinary intervention, which consisted of physiotherapy, cognitive-behavioural therapy and medication. The main outcomes were changes in the Roland Morris Disability Questionnaire (RMDQ), and the minimal clinically important differences. Secondary outcomes were changes in the McGill Pain (MGPQ) and Quality of Life (SF-12) questionnaires. Assessment was conducted at baseline, 3 and 12 months. Analysis was by intention-to-treat and analyst-blinded. Multiple imputations were used. RESULTS: Of the 501 enrolled patients, 421 (84%) provided data at 3 months, and 387 (77.2%) at 12 months. Mean age was 46.8 years (SD: 11.5) and 64.7% were women. In the adjusted analysis of the RMDQ outcome, only the intervention group showed significant changes at 3 months (- 1.33 points, p = 0.005) and at 12 months (- 1.11 points, p = 0.027), but minimal clinically important difference were detected in both groups. In the adjusted analysis of the RMDQ outcome, the intervention group improvement more than the control group at 3 months (- 1.33 points, p = 0.005) and at 12 months (- 1.11 points, p = 0.027). The intervention group presented a significant difference. Both groups presented a minimal clinically important difference, but more difference in the intervention group. The intervention group presented significant differences in the MGPQ scales of current pain intensity and VAS scores at 3 months. No statistically significant differences were found in the physical and mental domains of the SF-12. CONCLUSIONS: A multidisciplinary biopsychosocial intervention in a working population with non-specific subacute LBP has a small positive impact on disability, and on the level of pain, mainly at short-term, but no difference on quality of life. TRIAL REGISTRATION: ISRCTN21392091 (17 oct 2018) (Prospectively registred).

Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial.

BACKGROUND: Non-specific low back pain is a common cause for consultation with the general practitioner, generating increased health and social costs. This study will analyse the effectiveness of a multidisciplinary intervention to reduce disability, severity of pain, anxiety and depression, to improve quality of life and to reduce the incidence of chronic low back pain in the working population with non-specific low back pain, compared to usual clinical care. METHODS/DESIGN: A Cluster randomised clinical trial will be conducted in 38 Primary Health Care Centres located in Barcelona, Spain and its surrounding areas. The centres are randomly allocated to the multidisciplinary intervention or to usual clinical care. Patients between 18 and 65 years old (n = 932; 466 per arm) and with a diagnostic of a non-specific sub-acute low back pain are included. Patients in the intervention group are receiving the recommendations of clinical practice guidelines, in addition to a biopsychosocial multidisciplinary intervention consisting of group educational sessions lasting a total of 10 hours. The main outcome is change in the score in the Roland Morris disability questionnaire at three months after onset of pain. Other outcomes are severity of pain, quality of life, duration of current non-specific low back pain episode, work sick leave and duration, Fear Avoidance Beliefs and Goldberg Questionnaires. Outcomes will be assessed at baseline, 3, 6 and 12 months. Analysis will be by intention to treat. The intervention effect will be assessed through the standard error of measurement and the effect-size. Responsiveness of each scale will be evaluated by standardised response mean and receiver-operating characteristic method. Recovery according to the patient will be used as an external criterion. A multilevel regression will be performed on repeated measures. The time until the current episode of low back pain takes to subside will be analysed by Cox regression. DISCUSSION: We hope to provide evidence of the effectiveness of the proposed biopsychosocial multidisciplinary intervention in avoiding the chronification of low back pain, and to reduce the duration of non-specific low back pain episodes. If the intervention is effective, it could be applied to Primary Health Care Centres. TRIAL REGISTRATION: ISRCTN21392091.

[Cardiovascular disease epidemiology and risk factors in primary care]. / Epidemiología de las enfermedades cardiovasculares y factores de riesgo en atención primaria.

INTRODUCTION AND OBJECTIVES: To study the prevalence of and risk factors for cardiovascular disease in primary care. PATIENTS AND METHOD: A cross-sectional study was carried out at an urban health center in Barcelona, Spain. In total, 2248 patients > or =15 years old were selected randomly from medical records. The study investigated cardiovascular diseases such as ischemic heart disease, cerebrovascular disease and peripheral arterial disease, and cardiovascular risk factors such as age, sex, smoking, high blood pressure, hypercholesterolemia, hypertriglyceridemia, and diabetes mellitus. RESULTS: The patients' mean age was 49.1 (18.9) years and 53.5% were male. Cardiovascular risk factor prevalences were: smoking, 35.2%; high blood pressure, 33.7%; hypercholesterolemia, 21.9%; hypertriglyceridemia,12.7%; and diabetes mellitus, 15.8%. Overall, 57.9% of patients had at least 1 cardiovascular risk factor. Significantly more males presented with each risk factor (P<.05), apart from high blood pressure. The prevalence of all risk factors, except smoking, increased with age until 74 years and then stabilized, except high blood pressure, which continued to increase. Around 10% had cardiovascular disease, with myocardial ischemia in 5.5%, cerebrovascular disease in 3.7%, and peripheral arterial disease in 2.4%. All except cerebrovascular disease were significantly more common in males (P<.05). The prevalence of cardiovascular disease was low in individuals <55 years old, particularly women, and increased with age for all forms of disease. Some 68.3% were > or =65 years old. CONCLUSIONS: The high prevalence of cardiovascular risk factors was confirmed. Cardiovascular disease was more common in males and the elderly.

Epidemiología de las enfermedades cardiovasculares y factores de riesgo en atención primaria / Cardiovascular disease epidemiology and risk factors in primary care

Introdución y objetivos. Estudiar la prevalencia de las enfermedades cardiovasculares y sus factores de riesgo en atención primaria. Pacientes y método. Estudio descriptivo transversal realizado en un centro de salud urbano de Barcelona (España).Se incluyó a 2.248 pacientes ≥ 15 años, seleccionados mediante muestreo aleatorio simple del archivo de historias clínicas. Se estudiaron las siguientes enfermedades cardiovasculares: cardiopatía isquémica, enfermedad cerebrovascular y arteriopatía periférica de extremidades inferiores, y los siguientes factores de riesgo cardiovascular: edad, sexo, tabaquismo, hipertensión arterial, hipercolesterolemia, hipertrigliceridemia y diabetes mellitus. Resultados. La edad media fue de 49,1 ± 18,9 años y un 53,5% era mujer. La prevalencia de los factores de riesgo cardiovascular fue: tabaquismo, 35,2%; hipertensión arterial, 33,7%; hipercolesterolemia, 21,9%; hipertrigliceridemia,12,7%, y diabetes melitus, 15,8%. El 57,9%presentó al menos 1 factor de riesgo. Los varones presentaron una proporción superior (p < 0,05) excepto en la hipertensión arterial. Su prevalencia aumentó con la edad(excepto en el tabaquismo) hasta los 74 años, en que se estabilizó, excepto en la hipertensión, que siguió aumentando. Tenían alguna enfermedad cardiovascular el10,0% de los pacientes: cardiopatía isquémica el 5,5%;enfermedad cerebrovascular el 3,7% y arteriopatía periférica de extremidades inferiores el 2,4%. Fueron más frecuentes en varones (p < 0,05), excepto la enfermedad cerebrovascular. Su prevalencia fue baja en < 55 años(especialmente en mujeres) y aumentó con la edad en todas las enfermedades cardiovasculares, correspondiendo el 68,3% a pacientes de ≥ 65 años. Conclusiones. Se confirma la elevada prevalencia delos factores de riesgo cardiovascular en nuestro medio. Las enfermedades cardiovasculares son especialmente frecuentes en varones y ancianos

Introduction and objectives. To study the prevalence of and risk factors for cardiovascular disease in primary care. Patients and method. A cross-sectional study was carried out at an urban health center in Barcelona, Spain. In total, 2248 patients ≥15 years old were selected randomly from medical records. The study investigated cardiovascular diseases such as ischemic heart disease, cerebrovascular disease and peripheral arterial disease, and cardiovascular risk factors such as age, sex, smoking, high blood pressure, hypercholesterolemia, hypertriglyceridemia, and diabetes mellitus. Results. The patients’ mean age was 49.1 (18.9) years and 53.5% were male. Cardiovascular risk factor prevalences were: smoking, 35.2%; high blood pressure, 33.7%;hypercholesterolemia, 21.9%; hypertriglyceridemia,12.7%;and diabetes mellitus, 15.8%. Overall, 57.9% of patients had at least 1 cardiovascular risk factor. Significantly more males presented with each risk factor (P<.05), apart from high blood pressure. The prevalence of all risk factors, except smoking, increased with age until 74 years and then stabilized, except high blood pressure, which continued to increase. Around 10% had cardiovascular disease, with myocardial ischemia in 5.5%, cerebrovascular disease in3.7%, and peripheral arterial disease in 2.4%. All except cerebrovascular disease were significantly more common in males (P<.05). The prevalence of cardiovascular disease was low in individuals <55 years old, particularly women, and increased with age for all forms of disease. Some 68.3% were ≥65 years old. Conclusions. The high prevalence of cardiovascular risk factors was confirmed. Cardiovascular disease was more common in males and the elderly

[Association between clustering of cardiovascular risk factors and the risk of cardiovascular disease]. / Asociación entre la agrupación (clustering) de factores de riesgo cardiovascular y el riesgo de enfermedad cardiovascular.

BACKGROUND: Cardiovascular diseases are the main cause of mortality in Spain. The aim of this work was to study the association between clustering of cardiovascular risk factors and the risk of suffering major cardiovascular events: ischemic cardiopathy, cerebrovascular disease and peripheral arteriopathy of the lower limbs. METHOD: A descriptive transversal study was carried out in a city health centre, with a total of 2248 patients selected by simple random sampling of the clinical records with a mean age of 15 years. The data were obtained by examining the clinical records and estimating Odds Ratios (OR) for any cardiovascular event (n = 224), ischemic cardiopathy (n = 123), cerebrovascular disease (n = 84) and peripheral arteriopathy (n = 55) in relation to the number of cardiovascular risk factors. The cardiovascular risk factors included in the study were smoking, arterial hypertension, hypercholesterolemia, hypertriglyceridemia, diabetes and obesity. The OR was adjusted for age and sex. RESULTS: The percentage of patients with 0, 1, 2, 3 and 4-6 cardiovascular risk factors was 39.1, 32.8, 17.5, 6.9 and 3.7 respectively. The OR for experiencing a cardiovascular event associated to 1, 2, 3 and 4-6 cardiovascular risk factors was 1.6 (CI95%: 0.9-2.7), 2.8 (CI95%: 1.7-4.7), 3.6 (CI95%: 1.9-6.5) and 5.6 (CI95%: 2.9-10.8), respectively. The OR for ischemic cardiopathy associated to the same risk levels were 2.3 (CI95%: 1.1-4.6), 2.5 (CI95%: 1.2-5.2), 5.3 (CI95%: 2.4-11.5) and 6.2 (CI95%: 2.7-14.3), respectively. For cardiovascular disease, the OR were 1.1 (CI95%: 0.5-2.5), 2.3 (CI95%: 1.2-5.3), 2.4 (CI95%: 1.0-5.9) and 5.6 (CI95%: 2.2-14.1), respectively. The OR for peripheral arteriopathy were 2.1 (CI95%: 0.8-5.9), 3.7 (CI95%: 1.3-10.5), 3.3 (CI95%: 1.0-11.1) and 6.1 (CI95%: 1.8-20.3), respectively. CONCLUSIONS: The addition of cardiovascular risk factors is associated with an increased risk of cardiovascular events. This finding emphasises the need for prevention of cardiovascular risk factors in primary care.

Asociación entre la agrupación (clustering) de factores de riesgo cardiovascular y el riesgo de enfermedad cardiovascular / Association between Clustering of Cardiovascular Risk Factors and the Risk of Cardiovascular Disease

Fundamento: Las enfermedades cardiovasculares constituyen la principal causa de mortalidad en España. El objetivo del estudio es estudiar la asociación entre la agrupación (clustering) de factores de riesgo cardiovascular y el riesgo de padecer eventos cardiovasculares mayores: cardiopatía isquémica, enfermedad cerebrovascular y arteriopatía periférica de extremidades inferiores.Método: Se realizó un estudio descriptivo transversal, rea lizado en un centro de salud urbano. Se estudiaron 2.248 historias clínicas de personas con edad igual o superior a 15 años, seleccionadas mediante muestreo aleatorio simple. Los datos se obtuvieron por revisión de las historias clínicas, estimando la odds ratio (OR) para padecer algún evento cardiovascular (n = 224), cardiopatía isquémica (n = 123), enfermedad cerebrovascular (n = 84) y arteriopatía periférica (n = 55) respecto al número de factores de riesgo cardiovascular. Se incluyeron los factores de riesgo cardiovascular tabaquismo, hipertensión arterial, hipercolesterolemia, hipertrigliceridemia, diabetes y obesidad. La OR fue ajustada por edad y sexo.Resultados: El porcentaje de pacientes con 0,1, 2, 3 y 4-6 factores de riesgo cardiovascular fue de 39,1, 32,8, 17,5, 6,9 y 3,7 respectivamente. Las OR para el riesgo de tener algún evento cardiovascular asociada a 1, 2, 3 y 4-6 factores de riesgo cardiovascular fueron de 1,6 (IC95 per cent: 0,9-2,7), 2,8 (IC95 per cent: 1,7-4,7), 3,6 (IC95 per cent: 1,9-6,5) y 5,6 (IC95 per cent: 2,9-10,8), respectivamente. Las OR para la cardiopatía isquémica, asociada a los mismos niveles de riesgo, fueron de 2,3 (IC95 per cent: 1,1-4,6), 2,5 (IC95 per cent: 1,2-5,2), 5,3 (IC95 per cent: 2,4-11,5) y 6,2 (IC95 per cent: 2,7-14,3), respectivamente. Para la enfermedad cerebrovascular las OR fueron 1,1 (IC95 per cent: 0,5-2,5), 2,3 (IC95 per cent: 1,2-5,3), 2,4 (IC95 per cent: 1,0-5,9) y 5,6 (IC95 per cent: 2,2-14,1), respectivamente. Las OR para la arteriopatía periférica fueron 2,1 (IC95 per cent: 0,8-5,9 ), 3,7 (IC95 per cent: 1,3-10,5), 3,3 (IC95 per cent: 1,0-11,1) y 6,1 (IC95 per cent: 1,8-20,3), respectivamente.Conclusiones: La adición de factores de riesgo cardiovascular se asocia a un aumento del riesgo de eventos cardiovasculares. Este hecho refuerza la necesidad de realizar una prevención primaria de los factores de riesgo cardiovascular (AU)