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Date: October 5th, 2017
Reference: Brison et al. Effect of early supervised physiotherapy on recovery from acute ankle sprain: randomised controlled trial. BMJ Nov 2016.
Guest Skeptic: Dr. Steve Joseph. Steve completed his Sport Medicine fellowship training with the Fowler Kennedy Sport Medicine Clinic in 2017. He served with the Canadian Forces as a Medical Officer and Flight Surgeon. Steve is currently an Assistant Professor in the Department of Family Medicine at Western University working at the Fowler Clinic and the Roth McFarlane Hand and Upper Limb Centre.
Case: A 43-year-old male presents to your local rural emergency department Monday morning after rolling his ankle during his usual weekend pickup basketball game. He is Ottawa Ankle Rule positive but the x-ray shows no fracture.
Background: We have covered the Ottawa Ankle Rules (tools) early in Season#1 (SGEM#3). The Ottawa Ankle Rules are probably the most validated clinical decision instrument that have ever been published.
The Ottawa Ankle Rules have been validated down to five years of age and can be used to safely rule out ankle fractures.
These rules were created by the team in Ottawa lead by Dr. Ian Stiell who is a Legend of Emergency Medicine. You know what they say, those who published the clinical decision instruments get to make the rules.
Ankle sprains are one of the most common and burdensome injuries and are associated with a high rate of visits to an emergency department. Current evidence and clinical standards for acute management of simple sprains (Grade I and II) is limited and not well defined. This includes the role of supervised physiotherapy acutely.
There are some smaller studies in the past that have shown elements of physiotherapy to be of benefit in athlete populations.
- Hupperets et al. Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain: randomised controlled trial. BMJ 2009
- Janssen et al. Bracing superior to neuromuscular training for the prevention of self-reported recurrent ankle sprains: a three-arm randomised controlled trial. Br J Sports Med.
However, these studies deal with ankle sprains in a specific group as compared to a generalized emergency department population.
Clinical Question: Does a supervised physiotherapy program result in improved recovery from acute ankle sprains compared to usual care in adult patients presenting to an emergency department or urgent care clinic.
Reference: Brison et al. Effect of early supervised physiotherapy on recovery from acute ankle sprain: randomised controlled trial. BMJ Nov 2016.
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Population: Patient 16 years of age or older with a clinical diagnosis of a Grade I/II ankle sprain presenting to the emergency department or urgent care clinic within 72 hours of injury.
- Exclusion:Injury mechanisms that were inconsistent with a ligamentous sprain; the attending emergency physician determining the need for immobilization of the injured ankle or surgery based on clinical findings; presentation with concomitant injuries; other mobility limiting conditions; inability to accommodate the time intensive study protocol; and a declared plan to seek physiotherapy for treatment outside the study protocol.
- Intervention: Early supervised physiotherapy and usual care
- Comparison: Usual care (medical assessment, one page written summary of instruction for basic management of the injury at home, including ankle protection, R.I.C.E., pain medication as needed, graduated weight bearing activities, and set expectation for recovery. No physiotherapy was discussed).
- Outcome:
- Primary Outcome: Absolute proportion of patients achieving excellent recovery at three months (defined as greater than or equal to 450/500 on foot and ankle outcome score – FAOS)
- Secondary Outcome: FAOS at one and six months
Authors’ 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 in addition to usual care, as provided in this protocol.
Quality Checklist for Randomized Clinical Trials:
- The study population included or focused on those in the emergency Department. Yes
- The patients were adequately randomized. Yes
- The randomization process was concealed. Yes
- The patients were analyzed in the groups to which they were randomized. Yes
- The study patients were recruited consecutively (i.e. no selection bias). Unsure
- The patients in both groups were similar with respect to prognostic factors. Yes
- All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No
- All groups were treated equally except for the intervention Yes
- Follow-up was complete (i.e. at least 80% for both groups). Yes
- All patient-important outcomes were considered. Yes
- The treatment effect was large enough and precise enough to be clinically significant. No
Key Results: A total of 504 patients were recruited for the study (254 physiotherapy group and 250 usual care group). The mean age was about 31 years, slightly more women and about 70% were considered Grade II sprains.
No statistically or clinically significant difference between groups.
- Primary Outcome: Excellent Recovery at Three Months
- 43% physiotherapy group vs. 37% usual care group
- Absolute difference of 6% (95% CI -3% to 15%, p=0.26)
- Secondary Outcomes: No difference at one or six months
- One Month: 11% vs. 15% (95% CI -9% to 3%, p=27)
- Six Months: 57% vs. 62% (95% CI -5% to 5%, p=26)
- Subgroup Analysis: One small subgroup analysis by age (age under 30 at 3 months) has statistical significance for intervention. Subgroup analysis should be considered hypothesis generating only because the study was not powered for these outcomes.
- Selection Bias: Only about 1/3 (504/1,566) of eligible patients presenting with a simple ankle sprain were ultimately included in the study for a variety of reasons. Clinical judgement was used for both inclusion and exclusion of patients. This could have introduced selection bias. Given the hypothesis that physiotherapy would provide benefit, you would think the bias would have been in favor of the intervention, however that was not demonstrated.
- Blinding: The patients were not blinded to the treatment allocation. Patients were also not to reveal the allocation to blinded research staff. However, blinding may have been broken. Even if blinding was broken the bias should have favored the physiotherapy group.
- Power: They powered the study to find a 15% difference because that is what was considered clinically significant. For the primary outcome, they only found a 6% absolute difference in the intention-to- treat analysis. However, the 95% CI did go up to 15% in favor of the intervention. When they did their per-protocol analysis the effect size went down to only 2% (95% CI -8% to 13%, p=42).
- Selection of Instruments: The FAOS is a self-reporting scale. Self-reporting scales have their own inherent weaknesses. The FAOS has been considered to have content validity, construct validity and reliability. However, it is lacking in evidence for responsiveness. Responsiveness is ability of the tool to detect changes in a patient’s status over time. There are other instruments available to assess ankle sprains but they too have limitations (Martin and Irrgang 2007 and Shultz et el 2013).
- Standardized Physiotherapy: It is good to have a standardized protocol to follow for the intervention. However, their standardized physiotherapy program did not allow the use of bracing, taping, or manual therapies. These are often part of a physiotherapy program for sprained ankles. In addition, the true optimal dose, timing and intensity of ankle sprain rehabilitation is not known.
Comment on Authors’ Conclusion Compared to SGEM Conclusion: We generally agree with the authors’ conclusions.
SGEM Bottom Line: The current evidence does not support the referral of adult patients presenting to the emergency department or urgent care clinic with a simple ankle sprain for physiotherapy.
Case Resolution: The weekend warrior is diagnosed with a Grade I sprain and is given instructions for usual ankle sprain care.
Clinical Application: This is a good study to suggest that for the general population presenting to the emergency department or urgent care centre, outpatient physiotherapy is unlikely to provide benefit. However, we do have some evidence of benefit demonstrated in other studies looking at athletes. So, it all depends. In some cases further assessment by a sports medicine physician and referral to physiotherapy may be reasonable.
What do I tell my patient? Just roll with it…you have sprained your ankle. This should heal over time. It might take you a little longer than when you were a teenager. Get some rest, we will put on a tensor bandage to remind you to behave yourself and you can take some over-the-counter pain medicine if you want. Most people have an excellent recovery but it can take months. We do not have any evidence that physiotherapy can speed up your recovery. However, if you pain is getting worse, your function is going down or you are concerned then get in to see your family physician.
Keener Kontest: Last weeks’ winner was Simon McCormick. Simon is a consultant in EM at Rotherham Hospital in Yorkshire. He knew Withnail and I was the cult movie that a character advocates for the use of “unadulterated child’s piss” in an attempt to avoid a driving under the influence (DUI) charge.
Listen to the SGEM podcast on iTunes to hear this weeks’ keener question. If you know the answer, then send an email to TheSGEM@gmail.com with “keener” in the subject line. The first correct answer will receive a cool skeptical prize.
Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine.
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