Open Access Study protocol

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 Lamb12*, Ranjit Lall1, Zara Hansen1, Emma J Withers1, Frances E Griffiths3, Ala Szczepura4, Julie Barlow5, Martin R Underwood6 and the Back Skills Training Trial (BeST) Team

Author Affiliations

1 Warwick Clinical Trials Unit, Health Sciences Institute, Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK

2 Kadoorie Critical Care Research Centre, University of Oxford, Oxford OX3 9DU, UK

3 Primary Health Care Studies, Health Sciences Institute, Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK

4 Clinical Sciences Institute, Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK

5 Interdisciplinary Research Centre in Health, Faculty of Health & Life Sciences, Coventry University CV1 5FB, Coventry, UK

6 Centre for Health Sciences, Queen Mary University of London E1 4NS, UK

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BMC Musculoskeletal Disorders 2007, 8:14  doi:10.1186/1471-2474-8-14

Published: 22 February 2007

Abstract

Background

Low 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/Design

This 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.

Discussion

In this paper we describe the rationale and design of a randomised evaluation of a group based cognitive behavioural intervention for low back pain.