• Bmc Musculoskel Dis · Jan 2007

    Randomized Controlled Trial

    Design considerations in a clinical trial of a cognitive behavioural intervention for the management of low back pain in primary care: Back Skills Training Trial.

    • Sarah E Lamb, Ranjit Lall, Zara Hansen, Emma J Withers, Frances E Griffiths, Ala Szczepura, Julie Barlow, Martin R Underwood, and Back Skills Training Trial (BeST) Team.
    • Warwick Clinical Trials Unit, Health Sciences Institute, Warwick Medical School, University of Warwick, Coventry, UK. s.lamb@warwick.ac.uk
    • Bmc Musculoskel Dis. 2007 Jan 1;8:14.

    BackgroundLow back pain (LBP) is a major public health problem. Risk factors for the development and persistence of LBP include physical and psychological factors. However, most research activity has focused on physical solutions including manipulation, exercise training and activity promotion.Methods/DesignThis randomised controlled trial will establish the clinical and cost-effectiveness of a group programme, based on cognitive behavioural principles, for the management of sub-acute and chronic LBP in primary care. Our primary outcomes are disease specific measures of pain and function. Secondary outcomes include back beliefs, generic health related quality of life and resource use. All outcomes are measured over 12 months. Participants randomised to the intervention arm are invited to attend up to six weekly sessions each of 90 minutes; each group has 6-8 participants. A parallel qualitative study will aid the evaluation of the intervention.DiscussionIn this paper we describe the rationale and design of a randomised evaluation of a group based cognitive behavioural intervention for low back pain.

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