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

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.

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

“…The trial is designed by a team of researchers using a part of the results from the previous pilot and feasibility trial, in which a patient was a member of the trial steering committee 30 32. A patient will be planned to involve in this trial as a member of the trial management group.…”

“…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.…”

“…Moreover, the ABPI appeared better than standard physiotherapy in terms of pain reduction (Visual Analogue Scale for pain intensity), cervical range of motion (CROM) (CROM device), pressure pain threshold (digital pressure algometer) and general health status (EuroQol-5 dimensions 5 levels (EQ-5D-5L)). Furthermore, the number of physiotherapy sessions and the costs of management in the ABPI arm were lower than standard physiotherapy 32. The ABPI was acceptable to physiotherapists and patients, leading to the possibility for it enhancing physiotherapy practice in the future 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.…”