Open Access Study protocol

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

Anna Berenguera1, Enriqueta Pujol-Ribera1*, Teresa Rodriguez-Blanco1, Concepció Violan1, Marc Casajuana1, Nelleke de Kort1 and Marta Trapero-Bertran2

Author Affiliations

1 Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Institut Català de la Salut, C/Gran Via de les Corts Catalanes 587 àtic, 08007 Barcelona, Spain

2 Health Economics Research Group (Herg), Brunel University, Kingston Lane, Uxbridge, Middlesex UB83PH, Great Britain

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BMC Musculoskeletal Disorders 2011, 12:194  doi:10.1186/1471-2474-12-194

Published: 22 August 2011

Abstract

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