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

BACKGROUND: Low back pain (LBP), with high incidence and prevalence rate, is one of the most common reasons to consult the health system and is responsible for a significant amount of sick leave, leading to high health and social costs. The objective of the study is to assess the cost-effectiveness...

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Autores principales: Berenguera, Anna, Pujol-Ribera, Enriqueta, Rodriguez-Blanco, Teresa, Violan, Concepció, Casajuana, Marc, de Kort, Nelleke, Trapero-Bertran, Marta
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3170648/
https://www.ncbi.nlm.nih.gov/pubmed/21859489
http://dx.doi.org/10.1186/1471-2474-12-194
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author Berenguera, Anna
Pujol-Ribera, Enriqueta
Rodriguez-Blanco, Teresa
Violan, Concepció
Casajuana, Marc
de Kort, Nelleke
Trapero-Bertran, Marta
author_facet Berenguera, Anna
Pujol-Ribera, Enriqueta
Rodriguez-Blanco, Teresa
Violan, Concepció
Casajuana, Marc
de Kort, Nelleke
Trapero-Bertran, Marta
author_sort Berenguera, Anna
collection PubMed
description BACKGROUND: Low back pain (LBP), with high incidence and prevalence rate, is one of the most common reasons to consult the health system and is responsible for a significant amount of sick leave, leading to high health and social costs. The objective of the study is to assess the cost-effectiveness and cost-utility analysis of a multidisciplinary biopsychosocial educational group intervention (MBEGI) of non-specific sub-acute LBP in comparison with the usual care in the working population recruited in primary healthcare centres. METHODS/DESIGN: The study design is a cost-effectiveness and cost-utility analysis of a MBEGI in comparison with the usual care of non-specific sub-acute LBP. Measures on effectiveness and costs of both interventions will be obtained from a cluster randomised controlled clinical trial carried out in 38 Catalan primary health care centres, enrolling 932 patients between 18 and 65 years old with a diagnosis of non-specific sub-acute LBP. Effectiveness measures are: pharmaceutical treatments, work sick leave (% and duration in days), Roland Morris disability, McGill pain intensity, Fear Avoidance Beliefs (FAB) and Golberg Questionnaires. Utility measures will be calculated from the SF-12. The analysis will be performed from a social perspective. The temporal horizon is at 3 months (change to chronic LBP) and 12 months (evaluate the outcomes at long term). Assessment of outcomes will be blinded and will follow the intention-to-treat principle. DISCUSSION: We hope to demonstrate the cost-effectiveness and cost-utility of MBEGI, see an improvement in the patients' quality of life, achieve a reduction in the duration of episodes and the chronicity of non-specific low back pain, and be able to report a decrease in the social costs. If the intervention is cost-effectiveness and cost-utility, it could be applied to Primary Health Care Centres. TRIAL REGISTRATION: ISRCTN: ISRCTN58719694
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spelling pubmed-31706482011-09-11 Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial Berenguera, Anna Pujol-Ribera, Enriqueta Rodriguez-Blanco, Teresa Violan, Concepció Casajuana, Marc de Kort, Nelleke Trapero-Bertran, Marta BMC Musculoskelet Disord Study Protocol BACKGROUND: Low back pain (LBP), with high incidence and prevalence rate, is one of the most common reasons to consult the health system and is responsible for a significant amount of sick leave, leading to high health and social costs. The objective of the study is to assess the cost-effectiveness and cost-utility analysis of a multidisciplinary biopsychosocial educational group intervention (MBEGI) of non-specific sub-acute LBP in comparison with the usual care in the working population recruited in primary healthcare centres. METHODS/DESIGN: The study design is a cost-effectiveness and cost-utility analysis of a MBEGI in comparison with the usual care of non-specific sub-acute LBP. Measures on effectiveness and costs of both interventions will be obtained from a cluster randomised controlled clinical trial carried out in 38 Catalan primary health care centres, enrolling 932 patients between 18 and 65 years old with a diagnosis of non-specific sub-acute LBP. Effectiveness measures are: pharmaceutical treatments, work sick leave (% and duration in days), Roland Morris disability, McGill pain intensity, Fear Avoidance Beliefs (FAB) and Golberg Questionnaires. Utility measures will be calculated from the SF-12. The analysis will be performed from a social perspective. The temporal horizon is at 3 months (change to chronic LBP) and 12 months (evaluate the outcomes at long term). Assessment of outcomes will be blinded and will follow the intention-to-treat principle. DISCUSSION: We hope to demonstrate the cost-effectiveness and cost-utility of MBEGI, see an improvement in the patients' quality of life, achieve a reduction in the duration of episodes and the chronicity of non-specific low back pain, and be able to report a decrease in the social costs. If the intervention is cost-effectiveness and cost-utility, it could be applied to Primary Health Care Centres. TRIAL REGISTRATION: ISRCTN: ISRCTN58719694 BioMed Central 2011-08-22 /pmc/articles/PMC3170648/ /pubmed/21859489 http://dx.doi.org/10.1186/1471-2474-12-194 Text en Copyright ©2011 Berenguera et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Berenguera, Anna
Pujol-Ribera, Enriqueta
Rodriguez-Blanco, Teresa
Violan, Concepció
Casajuana, Marc
de Kort, Nelleke
Trapero-Bertran, Marta
Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial
title Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial
title_full Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial
title_fullStr Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial
title_full_unstemmed Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial
title_short Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial
title_sort study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3170648/
https://www.ncbi.nlm.nih.gov/pubmed/21859489
http://dx.doi.org/10.1186/1471-2474-12-194
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