A cluster randomised, double-blind pilot and feasibility trial of an active behavioural physiotherapy intervention for acute whiplash-associated disorder (WAD)II
Open accessAbstract
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.
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Some pilot trial publications have effectively reported pilot trial findings in a similar format to GRADE Summary of Findings tables.
“some pilot trial publications have effectively reported pilot trial findings in a similar format [32–35].”
From Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting (2023) · cites this paper as [35]
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Mellor, K., Albury, C., Dutton, S. J., Eldridge, S., & Hopewell, S. (2023) · Pilot and Feasibility Studies · doi:10.1186/s40814-023-01291-5 · Cited by 145 · see citing works
- Authors
- Wiangkham, T., Duda, J., Haque, M. S., Price, J., & Rushton, A.
- Affiliations
- Naresuan University (TH)
- University of Birmingham (GB)
- Birmingham Community Healthcare NHS Trust (GB)
- Corresponding author
- Rushton, Alison
- Venue
- PLOS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2019-05-09
- Volume
- 14
- Issue
- 5
- Pages
- e0215803
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC6508700
- OpenAlex
- W2944217298
- Cited by
- 22
- References
- 89
- Citations by year
- 2025: 2 · 2024: 1 · 2023: 5 · 2022: 4 · 2021: 5 · 2020: 3 · 2019: 1
- FWCI
- 2.01
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS ONE (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- University of Birmingham Research Portal (University of Birmingham) (publishedVersion, cc-by)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Figshare (submittedVersion, cc-by)
- Funders
- National Institute for Health and Care Research (ICA-PCAF-2018-01-117)
- Topics
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Automotive and Human Injury Biomechanics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy-related medical research
- Keywords
- whiplash-associated disorders, acute whiplash, complex interventions, chronicity prevention, neck pain, physiotherapy, feasibility, Neck Disability Index, cervical range of motion, pressure pain threshold, fear-avoidance beliefs, psychological factors
- MeSH terms
- Adult, Aged, Aged, 80 and over, Behavior Therapy, Double-Blind Method, Feasibility Studies, Female, Humans, Male, Middle Aged, Whiplash Injuries, Treatment Outcome, Physical Therapy Modalities, Young Adult
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