Research Article: A cluster randomised, double-blind pilot and feasibility trial of an active behavioural physiotherapy intervention for acute whiplash-associated disorder (WAD)II

Date Published: May 9, 2019

Publisher: Public Library of Science

Author(s): Taweewat Wiangkham, Joan Duda, M. Sayeed Haque, Jonathan Price, Alison Rushton, Belinda J Gabbe.

http://doi.org/10.1371/journal.pone.0215803

Abstract

Whiplash-associated disorder (WAD) causes substantial social and economic burden, with ≥70% patients classified as WADII (neck complaint and musculoskeletal sign(s)). Effective management in the acute stage is required to prevent development of chronicity; an issue for 60% of patients. An Active Behavioural Physiotherapy Intervention (ABPI) was developed to address both physical and psychological components of WAD. The ABPI is a novel complex intervention designed through a rigorous sequential multiphase project to prevent transition of acute WAD to chronicity. An external pilot and feasibility cluster randomised double-blind (assessor, participants) parallel two-arm clinical trial was conducted in the UK private sector. The trial compared ABPI versus standard physiotherapy to evaluate trial procedures and feasibility of the ABPI for managing acute WADII in preparation for a future definitive trial. Six private physiotherapy clinics were recruited and cluster randomised using a computer-generated randomisation sequence. Twenty-eight (20 ABPI, 8 standard physiotherapy) participants [median age 38.00 (IQR = 21.50) years] were recruited. Data were analysed descriptively with a priori establishment of success criteria. Ninety-five percent of participants in the ABPI arm fully recovered (Neck Disability Index ≤4, compared to 17% in the standard physiotherapy arm); required fewer treatment sessions; and demonstrated greater improvement in all outcome measures (pain intensity, Cervical Range of Motion, Pressure Pain Threshold, EuroQol-5 Dimensions) except for the Impact of Events Scale and Fear Avoidance Beliefs Questionnaire. The findings support the potential value of the ABPI, and that an adequately powered definitive trial to evaluate effectiveness (clinical, cost) is feasible with minor modifications to procedures.

Partial Text

Whiplash-associated disorders (WAD) describe a range of presentations that may be seen following whiplash injury owing to a wide variety of possible symptoms.[1] WAD is most commonly a consequence of road traffic accidents.[1] WAD is a major public health problem, with high annual economic costs estimated as $242 billion for the USA[2] and €180 billion for Europe.[3] Paralleling increasing healthcare costs are reduced work productivity and earning capacity.[4, 5] For example in Denmark, a decline of 20–25% in employment propensity was observed in the 2 years following a whiplash injury.[4] Insurance companies have also reported an increase in whiplash related costs,[6] particularly in the UK where insurance claim costs are considerable as individuals are largely managed within the private sector by the insurance companies.[6–12] The undesirable title of the ‘whiplash capital of Europe’ has been conferred on the UK by the Association of British Insurers, with estimates that 1 in 140 individuals make claims related to whiplash injury annually.[10] A total of 450,000–580,000 whiplash claims have been reported annually from road traffic accidents in the UK,[13] with estimates for the costs of personal injury claims rising from £7 to £14 billion over a 10 year period.[10] Interestingly, while the costs of whiplash are increasing, the number of patients experiencing WAD is likely to be stable.[13]

The trial was registered (BioMed Central, ISRCTN84528320) and conducted according to a pre-defined published protocol[37] in order to minimise potential biases, and subsequent deviations were reported. Research methods and reporting were in accordance with the CONSORT 2010 statement: extension to cluster randomised trials.[38] The trial is reported in line with the CONSORT 2010 statement: extension to randomised pilot and feasibility trials[39] (although the CONSORT statement was published after the protocol was developed).

This is the first trial investigating WAD management in the UK private insurance setting, and highlights the challenges for future research. The findings suggest that the ABPI is feasible (with regard to procedures, sample size and modified collection of data for cost-effectiveness analysis) and valuable (higher proportion of completely recovered participants, fewer treatment sessions, and reduced physiotherapy management costs than the standard physiotherapy). The findings support the appropriateness of conducting a future definitive trial to evaluate the effectiveness of the ABPI for the management of acute WADII with minor modifications.

 

Source:

http://doi.org/10.1371/journal.pone.0215803

 

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