Cargando…
Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic 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 impr...
Autores principales: | , , , , , , , , , , , , |
---|---|
Formato: | Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2010
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2820035/ https://www.ncbi.nlm.nih.gov/pubmed/20067619 http://dx.doi.org/10.1186/1472-6963-10-12 |
_version_ | 1782177340745318400 |
---|---|
author | Rodriguez-Blanco, Teresa Fernández-San-Martin, Isabel Balagué-Corbella, Montserrat Berenguera, Anna Moix, Jenny Montiel-Morillo, Elena Núñez-Juárez, Esther González-Moneo, Maria J Pie-Oncins, Magda Martín-Peñacoba, Raquel Roura-Olivan, Mercè Núñez-Juárez, Montse Pujol-Ribera, Enriqueta |
author_facet | Rodriguez-Blanco, Teresa Fernández-San-Martin, Isabel Balagué-Corbella, Montserrat Berenguera, Anna Moix, Jenny Montiel-Morillo, Elena Núñez-Juárez, Esther González-Moneo, Maria J Pie-Oncins, Magda Martín-Peñacoba, Raquel Roura-Olivan, Mercè Núñez-Juárez, Montse Pujol-Ribera, Enriqueta |
author_sort | Rodriguez-Blanco, Teresa |
collection | PubMed |
description | 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 |
format | Text |
id | pubmed-2820035 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2010 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-28200352010-02-11 Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic sub-acute low back pain in the working population: cluster randomised trial Rodriguez-Blanco, Teresa Fernández-San-Martin, Isabel Balagué-Corbella, Montserrat Berenguera, Anna Moix, Jenny Montiel-Morillo, Elena Núñez-Juárez, Esther González-Moneo, Maria J Pie-Oncins, Magda Martín-Peñacoba, Raquel Roura-Olivan, Mercè Núñez-Juárez, Montse Pujol-Ribera, Enriqueta BMC Health Serv Res Study protocol 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 BioMed Central 2010-01-12 /pmc/articles/PMC2820035/ /pubmed/20067619 http://dx.doi.org/10.1186/1472-6963-10-12 Text en Copyright ©2010 Rodriguez-Blanco 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 Rodriguez-Blanco, Teresa Fernández-San-Martin, Isabel Balagué-Corbella, Montserrat Berenguera, Anna Moix, Jenny Montiel-Morillo, Elena Núñez-Juárez, Esther González-Moneo, Maria J Pie-Oncins, Magda Martín-Peñacoba, Raquel Roura-Olivan, Mercè Núñez-Juárez, Montse Pujol-Ribera, Enriqueta Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic sub-acute low back pain in the working population: cluster randomised trial |
title | Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic sub-acute low back pain in the working population: cluster randomised trial |
title_full | Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic sub-acute low back pain in the working population: cluster randomised trial |
title_fullStr | Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic sub-acute low back pain in the working population: cluster randomised trial |
title_full_unstemmed | Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic sub-acute low back pain in the working population: cluster randomised trial |
title_short | Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic sub-acute low back pain in the working population: cluster randomised trial |
title_sort | study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic sub-acute low back pain in the working population: cluster randomised trial |
topic | Study protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2820035/ https://www.ncbi.nlm.nih.gov/pubmed/20067619 http://dx.doi.org/10.1186/1472-6963-10-12 |
work_keys_str_mv | AT rodriguezblancoteresa studyprotocolofeffectivenessofabiopsychosocialmultidisciplinaryinterventionintheevolutionofnonspeficicsubacutelowbackpainintheworkingpopulationclusterrandomisedtrial AT fernandezsanmartinisabel studyprotocolofeffectivenessofabiopsychosocialmultidisciplinaryinterventionintheevolutionofnonspeficicsubacutelowbackpainintheworkingpopulationclusterrandomisedtrial AT balaguecorbellamontserrat studyprotocolofeffectivenessofabiopsychosocialmultidisciplinaryinterventionintheevolutionofnonspeficicsubacutelowbackpainintheworkingpopulationclusterrandomisedtrial AT berengueraanna studyprotocolofeffectivenessofabiopsychosocialmultidisciplinaryinterventionintheevolutionofnonspeficicsubacutelowbackpainintheworkingpopulationclusterrandomisedtrial AT moixjenny studyprotocolofeffectivenessofabiopsychosocialmultidisciplinaryinterventionintheevolutionofnonspeficicsubacutelowbackpainintheworkingpopulationclusterrandomisedtrial AT montielmorilloelena studyprotocolofeffectivenessofabiopsychosocialmultidisciplinaryinterventionintheevolutionofnonspeficicsubacutelowbackpainintheworkingpopulationclusterrandomisedtrial AT nunezjuarezesther studyprotocolofeffectivenessofabiopsychosocialmultidisciplinaryinterventionintheevolutionofnonspeficicsubacutelowbackpainintheworkingpopulationclusterrandomisedtrial AT gonzalezmoneomariaj studyprotocolofeffectivenessofabiopsychosocialmultidisciplinaryinterventionintheevolutionofnonspeficicsubacutelowbackpainintheworkingpopulationclusterrandomisedtrial AT pieoncinsmagda studyprotocolofeffectivenessofabiopsychosocialmultidisciplinaryinterventionintheevolutionofnonspeficicsubacutelowbackpainintheworkingpopulationclusterrandomisedtrial AT martinpenacobaraquel studyprotocolofeffectivenessofabiopsychosocialmultidisciplinaryinterventionintheevolutionofnonspeficicsubacutelowbackpainintheworkingpopulationclusterrandomisedtrial AT rouraolivanmerce studyprotocolofeffectivenessofabiopsychosocialmultidisciplinaryinterventionintheevolutionofnonspeficicsubacutelowbackpainintheworkingpopulationclusterrandomisedtrial AT nunezjuarezmontse studyprotocolofeffectivenessofabiopsychosocialmultidisciplinaryinterventionintheevolutionofnonspeficicsubacutelowbackpainintheworkingpopulationclusterrandomisedtrial AT pujolriberaenriqueta studyprotocolofeffectivenessofabiopsychosocialmultidisciplinaryinterventionintheevolutionofnonspeficicsubacutelowbackpainintheworkingpopulationclusterrandomisedtrial |