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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN: ISRCTN58719694.
authors.affiliation: 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.
authors.forename: Anna
authors.initials: A
authors.lastname: Berenguera
authors.forename: Enriqueta
authors.initials: E
authors.lastname: Pujol-Ribera
authors.forename: Teresa
authors.initials: T
authors.lastname: Rodriguez-Blanco
authors.forename: Concepció
authors.initials: C
authors.lastname: Violan
authors.forename: Marc
authors.initials: M
authors.lastname: Casajuana
authors.forename: Nelleke
authors.initials: N
authors.lastname: de Kort
authors.forename: Marta
authors.initials: M
authors.lastname: Trapero-Bertran
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D016000:Cluster Analysis; D015331:Cohort Studies; D003131:Combined Modality Therapy / Q000379:methods*; D003362:Cost-Benefit Analysis / Q000379:methods*; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000191:economics* / Q000523:psychology / Q000534:rehabilitation*; D008297:Male; D008875:Middle Aged; D018710:Pain Clinics / Q000639:trends*; D010353:Patient Education as Topic / Q000379:methods*; D016037:Single-Blind Method; D013030:Spain / Q000453:epidemiology; D055815:Young Adult