title: 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.
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
  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.
  
  
  CONCLUSIONS
  In this paper we describe the rationale and design of a randomised evaluation of a group based cognitive behavioural intervention for low back pain.
authors.affiliation: Warwick Clinical Trials Unit, Health Sciences Institute, Warwick Medical School, University of Warwick, Coventry, UK. s.lamb@warwick.ac.uk
authors.forename: Sarah E
authors.initials: SE
authors.lastname: Lamb
authors.forename: Ranjit
authors.initials: R
authors.lastname: Lall
authors.forename: Zara
authors.initials: Z
authors.lastname: Hansen
authors.forename: Emma J
authors.initials: EJ
authors.lastname: Withers
authors.forename: Frances E
authors.initials: FE
authors.lastname: Griffiths
authors.forename: Ala
authors.initials: A
authors.lastname: Szczepura
authors.forename: Julie
authors.initials: J
authors.lastname: Barlow
authors.forename: Martin R
authors.initials: MR
authors.lastname: Underwood
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002985:Clinical Protocols / Q000592:standards; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D005239:Fear / Q000523:psychology; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000523:psychology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010147:Pain Measurement / Q000379:methods; D010342:Patient Acceptance of Health Care / Q000523:psychology / Q000706:statistics & numerical data; D018579:Patient Selection; D011320:Primary Health Care / Q000191:economics / Q000379:methods*; D011788:Quality of Life / Q000523:psychology; D012107:Research Design; D006113:United Kingdom