Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01995318 |
| Other study ID # |
YAcar - 1 |
| Secondary ID |
EtimesgutMH0001 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
November 20, 2013 |
| Last updated |
March 2, 2015 |
| Start date |
July 2013 |
| Est. completion date |
November 2013 |
Study information
| Verified date |
November 2013 |
| Source |
Etimesgut Military Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Turkey: Ministry of Health |
| Study type |
Interventional
|
Clinical Trial Summary
Study hypothesis: Kinesiotaping is effective in treatment of acute ankle sprains in
emergency department. It enhances Karlsson score more than elastic bandage.
Description:
Study design We conducted this prospective, randomized, blinded, clinical study in a
tertiary care setting's ED of which had an annual 600000 visits between July 2013 and
November 2013.
Selection of participants The patients whom reported an acutely twisted ankle were included
in the study. Exclusion criteria were; patients under 18, pregnancy, legally incompetent to
take responsibility, fracture at ankle and/or foot, unstable sprains requiring stabilization
with cast, 48 hours since injury occurrence, multiple injuries, have neurologic deficit at
lower extremities, chronic instability of ankle, had surgical treatment to ankle, knee and
hip.
Interventions After signing an informed consent form, eligible subjects were recruited for
the study and were randomly assigned to a kinesiotaping group or elastic bandage group. The
simple random number table used for randomization. All patients included in the study were
given standard therapy which includes rest for 2 days, elevation of the affected ankle from
heart level, ice application for 20 minutes 3 times per day for 5 days. The kinesiotaping
and elastic bandage were applied for 5 days. . Kinesiotaping group patients received
kinesiotaping applications with Kinesio Tex Gold ® tapes. Lymphatic correction was applied
depending on the size of ankle with 2 fan cut tapes with light paper-off tension on the
medial and lateral aspects of the ankle (3) Both modalities were applied by the same
certified researcher.
Pain scores were obtained using numeric pain rating scale (NPRS) from 0 to 10, with 0
analogous to ''no pain'' and 10 equivalent to ''the most severe pain encountered in life''.
Both groups were used also prescribed non-steroidal anti-inflammatory drugs (NSAID-
diclofenac sodium 75 mg per oral). After regular use for two days, patients were told to
take the additional doses if only they had pain. At the control days, they were questioned
whether they used any additional dose.
Active range of motion (ROM) was measured with a standard manual goniometer when patients
were seated on a treatment table with the knees fully extended (0°) and the feet hanging off
the end of the table.
Follow up measurements were done at 0, 3, 7, and 28 day by a blinded investigator. To
provide blinding, in follow ups patients were seen firstly by researcher who applied the
kinesiotaping or elastic bandage. Then the application was removed and then the follow-up
measurements were done by another researcher who did not know in which group was the patient
randomized. After this measurements, primary researcher applied the therapy again. Study was
registered to clinicaltrials.org website (ClinicalTrials.gov identifier: NCT01995318).
Sample size was calculated as 28 for each group. (mu (0): 40, mu (1): 48, sigma: 15,
two-sided, alpha: 0.05, power of test: 0.80) Outcome measures The primary outcome measure
was ankle joint function which was assessed with Karlsson scoring scale at the day seven.
This is a statistically validated scoring scale devised by Karlsson and Peterson. From a
maximum score of 90, points are given for a series of eight categories assessing the
following areas: pain (20 points), swelling (10 points), instability (subjective) (15
points), stiffness (5 points), stair climbing (10 points), running (10 points), work
activities (15 points), and the use of a support device (5 points) (4).
Secondary outcome measures were ankle girth (swelling) changes, the difference in NPRS
compared with initial presentation and the use of NSAID after 2 days. Ankle girth was
defined as the circumferential measurement of the ankle at the level of both malleoli.
Statistically analysis Statistically analysis were performed by SPSS 15.0 packet programme
(SPSS Inc, Chicago, IL) Normal distribution was assessed by Kolmogorov-Smirnov test.
Differences between groups were analyzed by t-test. For the differences in day 1, 3, and 7
were analyzed with repeated measures variance analysis. Difference between groups in day 28
was analyzed by Mann-Whitney U test. Chi-square test was used to evaluate the difference
between two groups in analgesic use.
