Effectiveness of Kinesiotaping in the Treatment of Acute Ankle Sprains (KINACAS)
Primary Purpose
Sprain of Ankle
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiotaping
Sponsored by
About this trial
This is an interventional treatment trial for Sprain of Ankle focused on measuring Kinesiotaping
Eligibility 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
Sites / Locations
- Bagcilar Education and Training Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Other
Arm Label
Elastic bandage
Kinesiotaping
Arm Description
Elastic bandage application as one of routine treatment choice of acute ankle sprains.
Application of anti-edema kinesiotaping
Outcomes
Primary Outcome Measures
Karlsson score enhancement
Secondary Outcome Measures
Full Information
NCT ID
NCT01995318
First Posted
November 20, 2013
Last Updated
March 2, 2015
Sponsor
Etimesgut Military Hospital
Collaborators
Bagcilar Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01995318
Brief Title
Effectiveness of Kinesiotaping in the Treatment of Acute Ankle Sprains
Acronym
KINACAS
Official Title
Effectiveness of Kinesiotaping in the Treatment of Acute Ankle Sprains
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Etimesgut Military Hospital
Collaborators
Bagcilar Training and Research Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sprain of Ankle
Keywords
Kinesiotaping
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elastic bandage
Arm Type
Placebo Comparator
Arm Description
Elastic bandage application as one of routine treatment choice of acute ankle sprains.
Arm Title
Kinesiotaping
Arm Type
Other
Arm Description
Application of anti-edema kinesiotaping
Intervention Type
Other
Intervention Name(s)
Kinesiotaping
Intervention Description
Application of anti-edema type kinesiotaping to injured ankle.
Primary Outcome Measure Information:
Title
Karlsson score enhancement
Time Frame
0-3-7 and 28 days after injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yahya A ACAR, MD
Organizational Affiliation
Etimesgut Military Hospital Ankara/Turkey
Official's Role
Study Director
Facility Information:
Facility Name
Bagcilar Education and Training Hospital
City
İstanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Kinesiotaping in the Treatment of Acute Ankle Sprains
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