Most physiotherapists try to incorporate evidence into their practice. So what do we do when a large trial published in a well read journal comes along and states that what we are doing is ineffective compared to minimal intervention? The British Medical Journal (BMJ) just published a study in November of 2016 on ankle sprains, comparing physiotherapy treatment to usual care (1). The outcomes, as you might have guessed by now, showed no difference between the two treatment interventions for Grade 1 and 2 sprains. Does this mean we should cease and desist from treating ankle sprains now? How does this information compare with other studies on ankle sprains and are there any issues with the BMJ study design?
The BMJ study from Brison et al. had an impressive study design and I can see why it was published in a high profile journal. There was over 500 participants in a randomized study with a specific treatment protocol. The usual care group received advice and education on conventional RICE treatment, use of analgesics, graduated weight bearing activities, and expected prognosis. The experimental group was advised to attend physiotherapy for exercise therapy and provided with a home exercise program. Outcome measures were performed at a three and six month follow-up and authors attempted to control for confounding variables as best they could.
Now from a clinical perspective, there does appear to be some limitations: the physiotherapy intervention was both limited with respect to scope and dosage. On average, participants attended 3 sessions of physiotherapy, likely not enough to impact the overall outcome. To impact the outcome the patient should be individually challenged near the boundaries of their current level of function, then sent home equipped with a progressive home exercise program with the potency to stimulate change. Again what is the probability 3 sessions of physiotherapy spread over three to six months leads to a full recovery? To belabour the point, in the Brison et al trial, proprioceptive and isotonic strength exercises were not supposed to start until 3-weeks post-injury! If it's a low grade sprain should we not start exposing patients to these in week 1 or by at least week 2 ?!? Isn't there a whole host of evidence on the benefits of early mobilization and proprioceptive exercise with ankle(2), knee(3), and hamstring(4) injuries…? Nonetheless, the physiotherapy protocol used in the trial was very rigid and if there is one thing we have seen over the last decade is that a “one-size fits all” treatment plans typically have limited efficacy leading to results such as “no difference” or “small effect sizes” across different treatment arms.
There are limitations with every study, but how does the Brison et al study then stack up previous trials for ankle sprains? In 2010, Bleakley and colleagues published an interesting RCT in the BMJ. They investigated the effect of early administration or “accelerated” use of therapeutic exercises versus a RICE protocol starting the first week after an acute ankle sprain (2). The researchers randomized 101 patients with mild ankle sprains to one of the two groups and guess what they found? Significant improvements in short-term ankle function compared with standard treatment! But in the end both groups finished on common ground, regressed toward the mean or reached “good” ankle function at 16-weeks. How they got to the end point differed and in our opinion matters. Wouldn't we want our patient's to hit their goals sooner rather than later? Authors then went on to say the early benefits of exercise found in this study “challenges popular advice on protection and rest for ankle sprains of minor and moderate severity.” Hmm, the Brison et al article did not start proprioceptive exercise until week 3, but the Bleakley et al. trial suggests we may want to start these early. What would you do?
Beyond missing the mark on a pragmatic graded exercise program there was no manual therapy provided to patients in the Brison trial despite there being evidence that manual therapy can improve short term outcomes in patients with ankle sprains. So with a closer look, can we ask again, did this study truly and accurately represent current best-evidence physiotherapy versus usual care? Where does the evidence lie with the use of manual therapy for acute ankle sprains?
It appears that if we get the exercise dosage right, usual care doesn't stand up in the short term. After exercise and usual care, there are other tools physiotherapists typically use for ankle sprains - manual therapy. So what does the literature have to say about manual therapy when it is added to the mix? Let us begin with a small RCT from Green et al., where authors compared RICE to RICE plus AP talocrural mobilizations. All subjects attended 3 to 6 treatments over a two-week period receiving RICE and education, with the experimental group receiving manual therapy every session. The results showed the addition of manual therapy to a conventional RICE protocol resulted in fewer treatments since subjects regained pain-free dorsiflexion (i.e. the discharge or success criteria) and stride speed` faster than RICE alone (5). This is just one small example highlighting the effects of manual therapy but there are many others looking at the positive short-term effects of MWM’s, mobilizations, and manipulations. One noteworthy study by Whitman et al found that 75% of the study population (n=64/85) with acute ankle sprain experienced success with manual therapy and general mobility exercises after 3 treatment sessions (7). They also went on to publish a clinical prediction rule to help identify those people with inversion ankle sprains likely to respond to manual therapy (FYI: symptoms worse when standing, worse in evening, navicular drop greater than 5.0 mm, and distal tibiofibular joint hypomobility). To date, this rule has not been validated, but nonetheless one exists.
Looking at a more pragmatic, less rigid but rigorous study, Cleland et al randomized 74 subjects with grade 1 or 2 ankle sprain to receive manual therapy plus exercise (MT-Ex) or exercise only. In both groups the treating therapist tailored the interventions to each subject's needs depending on the identified impairments and were treated over a 4-week period. The manual therapy came in the form of thrust and non-thrust joint mobilizations, similar to the Whitman et al study, directed at the proximal and distal tibiofibular joint, subtalar and talocrural joints. The outcomes of this trial found that the MT-Ex group outperformed the exercise only group. More specifically, the MT-Ex groups functional abilities improved from 66% to 87% at 4 weeks and to 97% at 6 months. This is a near full recovery for all subjects receiving manual therapy and exercise! Compare that to those only doing exercise which still saw improvement, but to a lesser extent: 73% at 4 weeks and 88% at 6 months. Hey, 88% is still pretty darn good. Other work has been done by Truyols-Domínguez et al investigating the addition of soft-tissue work to a program consisting of joint mobilization and exercise. Although both groups improved, a statistically greater improvement in pain and function was seen at the 1-month follow-up favoring the group that got it all - exercise, joint mobs, and soft-tissue work. All this to say is that poking and stretching the muscles and skin in various directions may provide additional effects.
This is not the first time and likely will not be the last time a large trial has been published and demonstrated a lack of efficacy for physiotherapy. In 2004, Frost et al. made headlines when their study that was published in the BMJ found treatments by a physiotherapist did not help low back pain outcomes compared to a single session of education (9). Again, this study had issues that decreased its clinical applicability: the control group got an hour of education with a physiotherapist on the importance of being active while the intervention group averaged five treatment sessions. This is particularly relevant considering 50% of all patient’s low back pain had persisted for greater than six months. Looking back 11 years later with our understanding of pain sciences, the patients in the control group probably received the most efficacious treatment - education and reassurance on remaining active. Similarly, back in 2013, Coombes et al published a trial on lateral epicondylalgia in JAMA. News quickly ran that physiotherapy and cortisone were ineffective for elbow pain. But when looking beyond the headlines and at the study in more detail, even though at 1 year all outcomes between the treatment arms were no different, the journey that led to the end point told a different story. To that end, the cortisone group had the best early improvement but 50% became symptomatic again at one year (10). In contrast, the physiotherapy group experienced early positive change in function and pain but did not experience any recurrence of symptoms at one year. So perhaps the headline should have read, Get PT 1st! Cortisone leads to short term gain but long term pain.
The latest BMJ study is not enough to change my clinical practice patterns but provides an opportunity to reflect on the body of literature regarding ankle sprains. With emerging research that challenges our profession and biases, remember to look through a critical lens and consider the existing evidence base before throwing the baby out with the bathwater and always make efforts to see where the article fits in your current practice. With this in mind, where does the Brison et al article fit? Depending on your bias, perhaps this study highlights the importance of a multimodal treatment plan that includes exercise and manual therapy compared to a stand alone exercise program. Instead, to some this study could lend insight into the importance of dosing an exercise program appropriately and tailoring it to the individual to help patients reach their personal goals. If that's the case, then is manual therapy still required?
Brison et al. Effect of early supervised physiotherapy on recovery from acute ankle sprain: randomised controlled trial. BMJ. 2016.
- Bleakley et al. Effect of accelerated rehabilitation on function after ankle sprain: randomised controlled trial. BMJ. 2010.
- Eitzen et al. A Progressive 5-Week Exercise Therapy Program Leads to Significant Improvement in Knee Function Early After Anterior Cruciate Ligament Injury. JOSPT. 2010.
Sherry et al. A Comparison of 2 Rehabilitation Programs in the Treatment of Acute Hamstring Strains. JOSPT. 2002.
Green et al. A Randomized Controlled Trial of a Passive Accessory Joint Mobilization on Acute Ankle Inversion Sprains. Physical Therapy. 2001.
Efficacy of Thrust and Non-thrust Manipulation and Exercise With or Without the Addition of Myofascial Therapy for the Management of Acute Inversion Ankle Sprain: A Randomized Clinical Trial
Whitman et al. Predicting Short-Term Response to Thrust and Non-thrust Manipulation and Exercise in Patients Post Inversion Ankle Sprain. JOSPT. 2009.
- Cleland et al. Manual Physical Therapy and Exercise Versus Supervised Home Exercise in the Management of Patients With Inversion Ankle Sprain: A Multicenter Randomized Clinical Trial. JOSPT. 2013.
- Frost et al. Randomised controlled trial of physiotherapy compared with advice for low back pain. BMJ. 2004.
- Coombes et la. Effect of Corticosteroid Injection, Physiotherapy, or Both on Clinical Outcomes in Patients With Unilateral Lateral Epicondylalgia: A Randomized Controlled Trial. JAMA. 2013.