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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

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Lamb, S. E. (Sallie E.), Lall, Ranjit, Hansen, Zara, Withers, Emma J., Griffiths, Frances, Szczepura, Ala, Barlow, Julie and Underwood, M. (Martin) M.D.. (2007) 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. BMC Musculoskeletal Disorders, Vol.8 (No.14). . ISSN 1471-2474

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Official URL: http://dx.doi.org/10.1186/1471-2474-8-14

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.

Item Type:	Journal Article
Subjects:	R Medicine > R Medicine (General) B Philosophy. Psychology. Religion > BF Psychology
Divisions:	Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Backache, Cognitive therapy, Clinical trials -- Great Britain
Journal or Publication Title:	BMC Musculoskeletal Disorders
Publisher:	BioMed Central Ltd.
ISSN:	1471-2474
Date:	22 February 2007
Volume:	Vol.8
Number:	No.14
Page Range:
Identification Number:	10.1186/1471-2474-8-14
Status:	Peer Reviewed
Access rights to Published version:	Open Access
Funder:	National Co-ordinating Centre for HTA (Great Britain)
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URI:	http://wrap.warwick.ac.uk/id/eprint/563