Abstract
BackgroundNon-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/DesignA 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.DiscussionWe 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 RegistrationISRCTN21392091
Highlights
Non-specific low back pain is a common cause for consultation with the general practitioner, generating increased health and social costs
If the intervention is effective, it could be applied to Primary Health Care Centres
This study showed that, management of the patients is consistent with the recommendations based on evidence, after two months of treatment, the pain continued in 37% and had worsened in 10% of patients [5]
Summary
Non-specific LBP is a prevalent disorder and a common reason for patient visit to GPs. We have assumed that the usual clinical care is homogeneous among clinicians that will participate in the study, namely, the standardized clinical guidelines of the Catalan Health Institute, “Clinical Practice Guidelines in the Pathology of the Lumbar Spine in Adults”, to which most of the GPs taking part in the study will belong. The five domains for clinical research that should be used in all LBP studies (symptoms, function, general well-being, work disability, and satisfaction with care) will be considered [41] Another strength is the variety of the risk factors addressed (demographic, clinical, psychological, social and professional characteristics), which enables an analysis of interrelations and allows identification and/or confirms the risk factors for chronic LBP. One notable aspect of the biopsychosocial multidisciplinary intervention is the promotion of the transdisciplinarity [43] between professionals, where team members feel empowered by the contribution of other colleagues
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