Effectiveness of Kinesiotaping in the Treatment of Acute Ankle Sprains (KINACAS)

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ClinicalTrials.gov Identifier: NCT01995318

Recruitment Status : Completed

First Posted : November 26, 2013

Last Update Posted : March 3, 2015

Sponsor:

Collaborator:

Bagcilar Training and Research Hospital

Information provided by (Responsible Party):

YAHYA AYHAN ACAR, Etimesgut Military Hospital

Study Description

Brief Summary:

Study hypothesis: Kinesiotaping is effective in treatment of acute ankle sprains in emergency department. It enhances Karlsson score more than elastic bandage.

Condition or disease	Intervention/treatment	Phase
Sprain of Ankle	Other: Kinesiotaping	Not Applicable

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Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	73 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Effectiveness of Kinesiotaping in the Treatment of Acute Ankle Sprains
Study Start Date :	July 2013
Actual Primary Completion Date :	July 2013
Actual Study Completion Date :	November 2013

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Elastic bandage Elastic bandage application as one of routine treatment choice of acute ankle sprains.
Kinesiotaping Application of anti-edema kinesiotaping	Other: Kinesiotaping Application of anti-edema type kinesiotaping to injured ankle.

Outcome Measures

Primary Outcome Measures :

Karlsson score enhancement [ Time Frame: 0-3-7 and 28 days after injury ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients in isolated acute ankle sprains in emergency department.

Exclusion Criteria:

Under 18 years
Pregnancy
Fracture
48 hours after injury
Chronic ankle instability
Nurologic deficit in lower extremity
Multipl trauma patients
Ankle, pelvis or knee surgery history

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995318

Locations

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Turkey
Bagcilar Education and Training Hospital
İstanbul, Turkey

Sponsors and Collaborators

Etimesgut Military Hospital

Bagcilar Training and Research Hospital

Investigators

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Study Director:	Yahya A ACAR, MD	Etimesgut Military Hospital Ankara/Turkey

More Information

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Responsible Party:	YAHYA AYHAN ACAR, MD., Etimesgut Military Hospital
ClinicalTrials.gov Identifier:	NCT01995318
Other Study ID Numbers:	YAcar - 1 EtimesgutMH0001 ( Other Identifier: EtimesgutMH0001 )
First Posted:	November 26, 2013 Key Record Dates
Last Update Posted:	March 3, 2015
Last Verified:	November 2013

Keywords provided by YAHYA AYHAN ACAR, Etimesgut Military Hospital:


Kinesiotaping

Additional relevant MeSH terms:

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Sprains and Strains Ankle Injuries Wounds and Injuries Leg Injuries

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