Tape versus semirigid versus lace-up ankle support in the treatment of acute lateral ankle ligament injury.

Injury to the anterolateral ligament complex of the ankle, or ankle sprain, is
a common problem in acute care practice. Incidence numbers for casualty
departments in the Netherlands disclose that approximately 80.000 registered
patients are treated each year for an acute ankle injury. The incidence is
estimated at 1 per 10.000 people per day and ankle sprains form about a quarter
of all sports injuries. Some sports (basketball, soccer and volleyball) have a
particularly high incidence of ankle injuries. Ankle sprains may lead to
persisting symptoms in 30-40% of all patients.
The lateral ankle ligament complex is formed by the anterior-talofibular, the
calcaneal fibular and the posterior-talofibular ligaments (respectively ATFL,
CFL, and PTFL).7 However, the number of ligaments injured does not affect the
prognosis and is therefore not considered relevant for the treatment either.
The most common mechanism of injury is supination and adduction (usually
referred to as inversion) of the plantar-flexed foot.
Ankle inversion injuries are usually classified according to a 3-stage grading
system: Grade I is a mild stretching of the ligament with no instability of the
joint, grade II is a partial rupture of the ligament with mild instability of
the joint, and grade III involves complete rupture of the ligaments with
instability of the joint. Due to pain and swelling, classification of patients
is often only possible after 4 to 5 days.
Primary treatment of inversion injuries is performed by different medical
disciplines, varying from primary health care and emergency physicians to
orthopaedic and trauma surgeons.5 The three main modalities of treatment for
inversion injuries are: 1) operative treatment, 2) conservative treatment by
immobilization with a plaster cast or splint and 3) functional conservative
treatment.
Today, the majority of patients are initially treated functionally. A Cochrane
Systematic Review about surgical versus conservative treatment for acute ankle
ligament injuries was inconclusive due to insufficient evidence, but
conservative treatment showed not be inferior either. A second Cochrane
Systematic Review showed that functional treatment is superior to
immobilization as conservative treatment for ankle ligament injuries. In
combination with financial and practical consideration and the possibility for
secondary reconstruction, initial functional treatment seems to be the best
treatment option for most of the patients.
Functional treatment usually consists of early mobilisation with full weight
bearing with external ankle support, e.g. tape, elastic bandage or a (lace-up)
brace, often combined with coordination training. Based on the best evidence
available, the Dutch CBO formulated the following consensus guideline about
ankle ligament injuries. Patients with a distortion without a rupture of their
lateral ankle ligament complex can be treated with a supporting elastic bandage
for a few days. The patient is allowed to walk and bear weight with normal
unwinding of their feet as soon as possible. When the patient has a rupture of
their lateral ankle ligament complex the treatment has to be adjusted to the
patient*s individual demands. A disadvantage of using a brace is that the
patient has to apply it by himself, whereas the advantage of taping is that the
doctor is responsible for correct application of the tape. A disadvantage of
taping is the potential risk of loosening of the tape and local skin
irritations, such as contact dermatitis and folliculitis. The treatment period
should be 6 weeks.
There is no high level evidence, with regard to clinical or financial outcome,
for the superiority of taping or bracing. According to the Cochrane Systematic
Review concerning different functional treatment options (tape, semi rigid
support, lace up support) for acute ankle ligament injuries *there is no most
effective treatment both clinically and in costs based on currently available
randomised trials. High quality, sufficiently powered randomised trials are
warranted to compare the effectiveness of different functional strategies for
treatment of an acute ankle sprain. An analysis of both direct and indirect
costs of different functional therapies should be incorporated as costs may
vary between strategies.

Two recent randomised trials show that the use of an ankle brace for the
treatment of lateral ankle ligament sprains produces better short term results
compared with standard management with an elastic support bandage.

Although most physicians probably consider the clinical result as most
important outcome, the socio-economic consequences of ankle sprains in general
are enormous. The costs for ankle injuries in the seventies were estimated at
approximately 35 million US dollars per million people. A Harvard study from
1983 estimated the annual costs for ankle ligament injuries in the US at
approximately 2 billion US dollars. Adjusted for inflation, today this would
equal 3.65 billion US dollars. In 1995, Zeegers estimated the total
socio-economic costs of ankle sprains in the Netherlands at approximately 1.3
billion Dutch guilders. Apart from direct cost (material, visits to emergency
department, outpatient clinic and consultant fees), these estimates include
indirect costs, like loss of income and incapacity to work during (part) of the
rehabilitation period.

The objective of this study is to compare tape versus semi rigid support versus
lace up brace treatment for acute lateral ankle ligament injuries with regard
to clinical outcome and cost effectiveness.

This study is designed as a single blind prospective randomized controlled
trial to evaluate the difference in functional outcome after treatment with
tape versus semi-rigid versus lace-up ankle support (brace) for grade II and
III acute lateral ankle ligament injuries. The patients will be randomly
allocated into one of the three groups. Randomization will be performed by
computer. Blinding of patients is not possible, but the observer will be
blinded at eight weeks and six months. Analysis of the data will be performed
in a blinded fashion.

Group 1 will be treated with adhesive non-elastic tape for six weeks. Group 2
will be treated with a semi-rigid brace for six weeks. Group 3 will be treated
with a lace up ankle support. Use and application will be explained by the
researcher using a standardised protocol. In case of complications another
treatment will be started but the patient will be evaluated according to the
intention to treat principle. Apart from the investigated treatment, patients
will undergo the same rehabilitation program: active range of motion training,
weight bearing as tolerated, and use of crutches until the pain subsides and
full weight bearing is reached. The use of additional treatment (ultrasound,
cryotherapy, laser, homeopathy and physiotherapy) will not be allowed.
Analgesics are allowed, with the exclusion of non-steroidal anti-inflammatory
drugs (NSAID*s) and morphine-mimetic drugs following the CBO guidelines.

The purpose and consequently the benefit of our study is to determine the
optimal non-surgical treatment for acute lateral ankle ligament injury, tape,
brace or lace-up brace treatment. To our knowledge there are no potential risks
for the included patients, as both treatments have been described as being safe
with little chance of complications. Only for tape, skin local irritations,
such as contact dermatitis and folliculitis, were reported. These complications
will resolve without any problem and can be reduced by practising proper
technique. The tape bandage can be too tight.