Effect of early supervised physiotherapy on recovery from acute ankle sprain: randomised controlled trial

Abstract

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.Trial registration ISRCTN 74033088 (www.isrctn.com/ISRCTN74033088).

Fig 1 Schematic representation of standardised programme of supervised physiotherapy, showing stages of progression, treatment goals for each stage, and criteria for progression or discharge. PRICE=protection, rest, ice, compression, elevation; ROM=range of motion; AROM=active ROM

Fig 2 Patient flow showing loss to follow-up, withdrawal, and missing data by study arm and outcome assessment period. Counts below randomisation are accumulative, with numbers in each box adding up to total number of patients allocated to given arm. Withdrawn=patients who actively refused to participate in further treatment or follow-up; lost to follow-up=patients who could not be contacted for current month assessment; missing FAOS=patients for whom FAOS at specified time point was not obtained

Fig 3 Intent to treat analysis of change in FAOS from baseline. Estimates are based on restricted maximum likelihood using all available FAOS scores from all patients

Fig 4 Per protocol analyses of change in FAOS from baseline. Estimates are based on restricted maximum likelihood using all available FAOS scores from all patients

Fig 5 Sensitivity analysis for missing FAOS data to assess “excellent” recovery at three months, plotting predicted proportion of recovery among 25 unknown participants in physiotherapy arm to predicted proportion among 36 unknown participants in control arm. Main axes (bottom and left) show percentages and secondary axes (top and right) show counts

Fig 6 Intent to treat analysis of change in clinical and biomechanical measures from baseline. All estimates reported as increase from baseline, with exception of figure of eight measure of oedema, which is reported as decrease from baseline, so that greater increase is consistently favourable. Estimates based on restricted maximum likelihood using all available measures from all randomised participants

Fig 7 Per protocol analyses of change in clinical and biomechanical measures from baseline. All estimates reported as increase from baseline, with exception of figure of eight measure of oedema, which is reported as decrease from baseline, so that greater increase is consistently favourable. Estimates based on restricted maximum likelihood using all available measures from all randomised participants