Tape versus semi-rigid ankle support in the treatment of acute lateral ankle ligament injury.

1. Karlsson scoring scale 37

We ask the patient to fill out a questionnaire regarding the function of the

ankle joint. The score includes eight items based on a subjective evaluation of

stability, pain, swelling and stiffness in relation to activities of everyday

life, sports and recreational activities, running, stair climbing and working

ability. The maximum score is 100 points. (Appendix B)



Excellent 90-100 points

Good 80-89 points

Fair 60-79 points

Poor <=60 points

2. Foot and Ankle Outcome Score. FAOS (Appendix A).34, 35

· FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living

(ADL), Function in sport and recreation (Sport Rec), and foot and ankle-related

Quality of Life (QOL). The last week is taken into consideration when answering

the questionnaire. Standardized answer options are given (% Likert boxes) and

each question gets a score from 0 to 4. A normalized score (100 indicating no

symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

The result can be plotted as an outcome profile.

· FAOS content is based on the Knee injury and Osteoarthritis Outcome Score

(KOOS) 34, content validity was confirmed by 213 patients with ankle

instability. 35

· FAOS was developed to assess the patients* opinion about a variety of foot

and ankle related problems. FAOS is patient-administered and takes about 10

minutes to fill out.

3. Return to work

· Time to return to work

· Work at level / below level / no return to work

4. Return to sports.

· Time to return to sports

· Sports at level / below level /no return to sports

5. Pain

· VAS score 0-10: 0 = no pain, 10 = unbearable pain

6. Objective instability

· Objective instability of the ankle is either measured during physical

examination using the TTT (>=90 or >= 30 difference with uninjured ankle) The

talar tilt test or inversion stress test is performed in the same position and

a varus force is applied to the heel. In maximal dorsiflexion the contribution

of the subtalar joint is minimised and the calcaneo-fibular ligament is taut.

This is a test predominantly of the calcaneo-fibular ligament. The second test

is the Anterior Drawer Test (ADT). The patient sits on a bench with the legs

hanging downwards. The knee joint is flexed and the foot held in 150 plantar

flexion. First the healthy ankle is examined. Examination is performed

according to van Dijk. 38 The examiner assigned one of the four predetermined

numbers to each examined ankle joint, based on the estimated anterior

displacement of the talus relative to the tibia.

o 0 = 0-2mm, 1 = 3-5mm, 2 = 6-10mm and 3 = 11-15mm.

· Because the manual ADT is of a subjective nature we measure the instability

with the dynamic anterior ankle tester (DAAT). 39 The principle of the test is

to apply a force impulse tot the calcaneus, within the muscle reflex time, and

to measure anterior-posterior translation and mediolateral rotation. The

highest and the lowest score were discarded and the mean of the three remaining

scores counted as the result of the test.

7. Range of motion

· Degrees maximum dorsiflexion to plantarflexion

· Limited: yes / no (>5 degrees, compared to healthy side)

8. Recurrent inversion injury

· Yes/no

· Number of sprains per month

9. Complications / Adverse events

· Any event leading to discontinuation of study participation and temporary or

permanent physical damage due to the treatment under investigation (Local skin

irritations (contact dermatitis and folliculitis), sensory deficit, stiffness,

muscle atrophy)

· Yes / no

· Total number of complications per patient and per group

10. Tegner activity level (modified, Appendix C) 33

· Mean per group

11. EuroQol

The EuroQol (EQ5D) is a health related quality of life instrument that

provides a single index of an individual*s quality of life. It consists of 5

dimensions resulting in 243 possible health states.

12. Preference of the patient for brace or tape treatment.

· (Tape/Brace)

13. Compliance

· How many days did you not wear the brace?

· Tape compliance is always 100%

14.Economic evaluation

. The main objective of the economic evaluation is to assess

the cost effectiveness and cost-utility of brace and tape therapy of acute

lateral ankle ligament injury. The economic evaluation will be performed from a

societal perspective, implying that all relevant costs, such as costs of the

intervention, other health care costs, patient and family costs and costs of

production loss will be used as economic indicators