Open Access Study protocol

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

Teresa Rodriguez-Blanco1, Isabel Fernández-San-Martin2, Montserrat Balagué-Corbella3, Anna Berenguera1, Jenny Moix4, Elena Montiel-Morillo5, Esther Núñez-Juárez6, Maria J González-Moneo7, Magda Pie-Oncins7, Raquel Martín-Peñacoba8, Mercè Roura-Olivan2, Montse Núñez-Juárez9 and Enriqueta Pujol-Ribera1*

Author Affiliations

1 Institut 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 SAP Litoral, Institut Català de la Salut, C/Lope de Vega 138, 08005, Barcelona, Spain

3 Societat Catalana de Medicina Familiar i Comunitària (CAMFIC), C/Portaferrissa n°8 Pral, 08002 Barcelona, Spain

4 Facultat de Psicologia, Universitat Autònoma de Barcelona, 08193 Bellaterra, Barcelona, Spain

5 Hospital de Sant Pau, C/Sant Antoni Maria Claret 167,08025 Barcelona, Spain

6 SAP de suport al Diagnostic i Tractament, Institut Català de la Salut, Av. De les Drassanes, 17-21, 08001 Barcelona, Spain

7 EAP Verneda Nord, Institut Català de la Salut, Pl. de la Infància, s/n, 08020, Barcelona, Spain

8 EAP Manso, Institut Català de la Salut, Manso 19, 08015 Barcelona, Spain

9 Hospital Clínic i Provincial de Barcelona, Villarroel 170, 08036, Barcelona, Spain

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BMC Health Services Research 2010, 10:12  doi:10.1186/1472-6963-10-12

Published: 12 January 2010

Abstract

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