A cluster randomised, double-blind pilot and feasibility trial of an active behavioural physiotherapy intervention for acute whiplash-associated disorder (WAD)II.
Taweewat WiangkhamJoan DudaM Sayeed HaqueJonathan PriceAlison B RushtonPublished in: PloS one (2019)
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.
Keyphrases
- clinical trial
- study protocol
- randomized controlled trial
- phase iii
- double blind
- phase ii
- open label
- placebo controlled
- liver failure
- end stage renal disease
- respiratory failure
- healthcare
- chronic kidney disease
- chronic pain
- newly diagnosed
- ejection fraction
- pain management
- aortic dissection
- drug induced
- multiple sclerosis
- patient reported outcomes
- radiation therapy
- systematic review
- physical activity
- cross sectional
- hepatitis b virus
- squamous cell carcinoma
- machine learning
- big data
- mass spectrometry
- patient reported
- extracorporeal membrane oxygenation
- mechanical ventilation
- rectal cancer