title: Study protocol of effectiveness 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
  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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN21392091.
authors.affiliation: Institut d'Investigació en Atenció Primària Jordi Gol, Institut Català de la Salut, 08007 Barcelona, Spain.
authors.forename: Teresa
authors.initials: T
authors.lastname: Rodriguez-Blanco
authors.forename: Isabel
authors.initials: I
authors.lastname: Fernández-San-Martin
authors.forename: Montserrat
authors.initials: M
authors.lastname: Balagué-Corbella
authors.forename: Anna
authors.initials: A
authors.lastname: Berenguera
authors.forename: Jenny
authors.initials: J
authors.lastname: Moix
authors.forename: Elena
authors.initials: E
authors.lastname: Montiel-Morillo
authors.forename: Esther
authors.initials: E
authors.lastname: Núñez-Juárez
authors.forename: Maria J
authors.initials: MJ
authors.lastname: González-Moneo
authors.forename: Magda
authors.initials: M
authors.lastname: Pie-Oncins
authors.forename: Raquel
authors.initials: R
authors.lastname: Martín-Peñacoba
authors.forename: Mercè
authors.initials: M
authors.lastname: Roura-Olivan
authors.forename: Montse
authors.initials: M
authors.lastname: Núñez-Juárez
authors.forename: Enriqueta
authors.initials: E
authors.lastname: Pujol-Ribera
mesh_terms: D000208:Acute Disease; D000328:Adult; D000700:Analgesics / Q000627:therapeutic use; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D004651:Employment; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000523:psychology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic; D026741:Physical Therapy Modalities; D013030:Spain; D055815:Young Adult
chemical_list: D000700:Analgesics