title: Acute Whiplash Injury Study (AWIS): a protocol for a cluster randomised pilot and feasibility trial of an Active Behavioural Physiotherapy Intervention in an insurance private setting.
abstract: Whiplash-associated disorder (WAD) causes substantial social and economic burden internationally. Up to 60% of patients with WAD progress to chronicity. Research therefore needs to focus on effective management in the acute stage to prevent the development of chronicity. Approximately 93% of patients are classified as WADII (neck complaint and musculoskeletal sign(s)), and in the UK, most are managed in the private sector. In our recent systematic review, a combination of active and behavioural physiotherapy was identified as potentially effective in the acute stage. An Active Behavioural Physiotherapy Intervention (ABPI) was developed through combining empirical (modified Delphi study) and theoretical (social cognitive theory focusing on self-efficacy) evidence. This pilot and feasibility trial has been designed to inform the design of an adequately powered definitive randomised controlled trial.
  
  
  
  Two parallel phases. (1) An external pilot and feasibility cluster randomised double-blind (assessor and participants), parallel two-arm (ABPI vs standard physiotherapy) clinical trial to evaluate procedures and feasibility. Six UK private physiotherapy clinics will be recruited and cluster randomised by a computer-generated randomisation sequence. Sixty participants (30 each arm) will be assessed at recruitment (baseline) and at 3 months postbaseline. The planned primary outcome measure is the neck disability index. (2) An embedded exploratory qualitative study using semistructured indepth interviews (n=3-4 physiotherapists) and a focus group (n=6-8 patients) and entailing the recruitment of purposive samples will explore perceptions of the ABPI. Quantitative data will be analysed descriptively. Qualitative data will be coded and analysed deductively (identify themes) and inductively (identify additional themes).
  
  
  
  This trial is approved by the University of Birmingham Ethics Committee (ERN_15-0542).
  
  
  
  ISRCTN84528320.
authors.affiliation: School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Taweewat
authors.initials: T
authors.lastname: Wiangkham
authors.affiliation: School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Joan
authors.initials: J
authors.lastname: Duda
authors.affiliation: Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
authors.forename: M Sayeed
authors.initials: MS
authors.lastname: Haque
authors.affiliation: Physio 1st, Birmingham, UK.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Price
authors.affiliation: School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Alison
authors.initials: A
authors.lastname: Rushton
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001521:Behavior Therapy; D005081:Exercise Therapy; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009333:Neck; D017063:Outcome Assessment, Health Care; D017060:Patient Satisfaction; D026741:Physical Therapy Modalities; D010865:Pilot Projects; D017149:Private Sector; D012107:Research Design; D006113:United Kingdom; D014911:Whiplash Injuries / Q000628:therapy*; D055815:Young Adult
keywords: Active Behavioural Physiotherapy Intervention (ABPI); Acute whiplash; Cluster randomisation; Pilot and feasibility; Private setting; Whiplash