Effect of early supervised physiotherapy on recovery from acute ankle sprain: randomised controlled trialBMJ 2016; 355 doi: https://doi.org/10.1136/bmj.i5650 (Published 16 November 2016) Cite this as: BMJ 2016;355:i5650
- Robert J Brison, professor of emergency medicine1 2 3,
- Andrew G Day, senior biostatistician2 3,
- Lucie Pelland, associate professor of rehabilitation therapy4 5,
- William Pickett, professor of public health sciences1 3,
- Ana P Johnson, associate professor of public health sciences3,
- Alice Aiken, professor of rehabilitation therapy4,
- David R Pichora, professor of surgery5 6,
- Brenda Brouwer, professor of rehabilitation therapy4 5
- 1Queen’s University Department of Emergency Medicine, Kingston, ON, Canada
- 2Kingston General Hospital Research Institute, Kingston, ON, Canada
- 3Queen’s University Department of Public Health Sciences, Kingston, ON, Canada
- 4Queen’s University School of Rehabilitation Therapy, Kingston, ON, Canada
- 5The Human Mobility Research Centre, Kingston General Hospital and Queen’s University, Kingston, ON, Canada
- 6Queen’s University Division of Orthopaedics, Kingston, ON, Canada
- Correspondence to: R J Brison, Queen’s University, Clinical Research Centre, Victory 3, Kingston General Hospital, 76 Stuart Street, Kingston, ON, K7L 2V7, Canada
- Accepted 18 October 2016
Objective To assess the efficacy of a programme of supervised physiotherapy on the recovery of simple grade 1 and 2 ankle sprains.
Design A randomised controlled trial of 503 participants followed for six months.
Setting Participants were recruited from two tertiary acute care settings in Kingston, ON, Canada.
Participants The broad inclusion criteria were patients aged ≥16 presenting for acute medical assessment and treatment of a simple grade 1 or 2 ankle sprain. Exclusions were patients with multiple injuries, other conditions limiting mobility, and ankle injuries that required immobilisation and those unable to accommodate the time intensive study protocol.
Intervention Participants received either usual care, consisting of written instructions regarding protection, rest, cryotherapy, compression, elevation, and graduated weight bearing activities, or usual care enhanced with a supervised programme of physiotherapy.
Main outcome measures The primary outcome of efficacy was the proportion of participants reporting excellent recovery assessed with the foot and ankle outcome score (FAOS). Excellent recovery was defined as a score ≥450/500 at three months. A difference of at least 15% increase in the absolute proportion of participants with excellent recovery was deemed clinically important. Secondary analyses included the assessment of excellent recovery at one and six months; change from baseline using continuous scores at one, three, and six months; and clinical and biomechanical measures of ankle function, assessed at one, three, and six months.
Results The absolute proportion of patients achieving excellent recovery at three months was not significantly different between the physiotherapy (98/229, 43%) and usual care (79/214, 37%) arms (absolute difference 6%, 95% confidence interval −3% to 15%). The observed trend towards benefit with physiotherapy did not increase in the per protocol analysis and was in the opposite direction by six months. These trends remained similar and were never statistically or clinically important when the FAOS was analysed as a continuous change score.
Conclusions In a general population of patients seeking hospital based acute care for simple ankle sprains, there is no evidence to support a clinically important improvement in outcome with the addition of supervised physiotherapy to usual care, as provided in this protocol.
We thank D Emerton, who coordinated data collection, X Sun, who assisted with data analysis, S Dostaler, who assisted with trial development and registration, and I Bielska for maintaining literature reviews. We also thank all participants for their time and commitment to our study and participants involved in the pilot phase of our trial, who provided feedback on our methods and procedures.
Contributors: RJB and AGD were responsible for data integrity and analyses for the study. All authors contributed to the study concept and design. RJB and BB were responsible for data acquisition. AGD, RJB, BB, and WP were responsible for the statistical analysis and interpretation. RJB, AGD, LP, BB, and WP drafted the manuscript. All authors contributed to the critical revision of the manuscript for intellectual content. Study supervision was provided by RJB and BB. RJB is guarantor.
Funding: The study was funded by the Canadian Institutes of Health Research (MCT-94833). The sponsors had no role in the design, conduct, and analysis or involvement in the preparation or submission of the manuscript for publication
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: This study was approved by Queen’s University Health Sciences Research Ethics Board (file No 6004187) and informed consent was given by all patients.
Data sharing: The investigators will share data (with associated coding library) used in developing the results presented in this manuscript on request (from AGD, firstname.lastname@example.org). Anonymised record level data would be made available on request to investigators who have submitted a publicly available proposal for analysis and who have received ethical clearance from their host institution.
Transparency: The lead author affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
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