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

IntroductionWhiplash-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.Methods and analysisTwo 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).Ethics and disseminationThis trial is approved by the University of Birmingham Ethics Committee (ERN_15-0542).Trial registration numberISRCTN84528320.

Pragmatic cluster randomised double-blind pilot and feasibility trial of an active behavioural physiotherapy intervention for acute non-specific neck pain: a mixed-methods protocol

“…Although whiplash-associated disorders (WAD) and non-specific neck pain can be different in the mechanism of injury and severity, their conditions and clinical characteristics are similar 24–27. An active behavioural physiotherapy intervention (ABPI) may, therefore, be useful in managing patients with non-specific neck pain based on the findings of the previous Acute Whiplash Injury Study (AWIS) pilot and feasibility trial 28–32. The findings demonstrated that 95% of the patients who received the ABPI fully recovered at 3 months follow-up, whereas approximately 17% of the patients who received standard physiotherapy fully recovered using a cut-off on the Neck Disability Index (NDI) ≤4 30–32.…”

“…An active behavioural physiotherapy intervention (ABPI) may, therefore, be useful in managing patients with non-specific neck pain based on the findings of the previous Acute Whiplash Injury Study (AWIS) pilot and feasibility trial 28–32. The findings demonstrated that 95% of the patients who received the ABPI fully recovered at 3 months follow-up, whereas approximately 17% of the patients who received standard physiotherapy fully recovered using a cut-off on the Neck Disability Index (NDI) ≤4 30–32. This suggests that the ABPI could prevent chronicity among the patients with WADII (≥3 months is classified as chronic stage) 33.…”

“…Originally, the ABPI was developed through a sequential multiphase project using rigorous, precise and transparent methodologies in order to manage the patients with acute WAD 28–32. The ABPI is a flexible complex intervention combining active physiotherapy and behavioural intervention (underpinned by social cognitive theory focusing self-efficacy enhancement) 28–31.…”

“…Originally, the ABPI was developed through a sequential multiphase project using rigorous, precise and transparent methodologies in order to manage the patients with acute WAD 28–32. The ABPI is a flexible complex intervention combining active physiotherapy and behavioural intervention (underpinned by social cognitive theory focusing self-efficacy enhancement) 28–31. It contains logical concept and phases (ie, understanding, maturity, stamina and coping) covering both physical and psychological management,29–31 which seems to be suitable to address the problems in the patients with non-specific neck pain.…”

“…The ABPI is a flexible complex intervention combining active physiotherapy and behavioural intervention (underpinned by social cognitive theory focusing self-efficacy enhancement) 28–31. It contains logical concept and phases (ie, understanding, maturity, stamina and coping) covering both physical and psychological management,29–31 which seems to be suitable to address the problems in the patients with non-specific neck pain. Owing to no report of WAD as a health problem in Thailand but non-specific neck pain being a substantial problem34 and possible value of the ABPI, the ABPI is, therefore, first investigate as a pilot and feasibility clinical trial in order to manage the patients with acute non-specific neck pain in a public Thai physiotherapy setting.…”