Sprain of AnkleKINACASNCT01995318
Effectiveness of Kinesiotaping in the Treatment of Acute Ankle Sprains
A study testing Kinesiotaping in people with Sprain of Ankle, run by Etimesgut Military Hospital at 1 site in Turkey (Türkiye).
Trial summary
Study hypothesis: Kinesiotaping is effective in treatment of acute ankle sprains in emergency department. It enhances Karlsson score more than elastic bandage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sprain of Ankle
- What is being tested?
- Kinesiotaping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in isolated acute ankle sprains in emergency department.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Education and Training Hospital
Istanbul
About this study
Study hypothesis: Kinesiotaping is effective in treatment of acute ankle sprains in emergency department. It enhances Karlsson score more than elastic bandage.
Read the 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.
- Conditions
- Sprain of Ankle
- Being tested
- Kinesiotaping
- Keywords
- Kinesiotaping
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingOther
Application of anti-edema type kinesiotaping to injured ankle.
| Study group | Role | What they receive |
|---|---|---|
| Elastic bandage | Placebo comparator | Elastic bandage application as one of routine treatment choice of acute ankle sprains. |
| Kinesiotaping | Other | Application of anti-edema kinesiotaping Receives: Other: Kinesiotaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Karlsson score enhancement
Measured: 0-3-7 and 28 days after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sprain of AnkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Etimesgut Military Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bagcilar Training and Research Hospital
- Responsible party
- Principal investigator, YAHYA AYHAN ACAR, Etimesgut Military Hospital
- Investigators
- Yahya A ACAR, MD, Study director, Etimesgut Military Hospital Ankara/Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995318
- Sponsor's protocol ID
- YAcar - 1
- Other IDs
- EtimesgutMH0001
- Acronym
- KINACAS
- Status last verified
- Nov 2013
- First submitted
- 20 Nov 2013
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Kinesiotaping in the Treatment of Acute Ankle Sprains
- ClinicalTrials.gov ID
- NCT01995318
- Acronym / sponsor ID
- KINACAS / YAcar - 1
- Conditions
- Sprain of Ankle
- Keywords
- Kinesiotaping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Etimesgut Military HospitalUniversity, hospital or other
- Collaborators
- Bagcilar Training and Research Hospital
- Study start
- Jul 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elastic bandage | Placebo comparator | –Elastic bandage application as one of routine treatment choice of acute ankle sprains. |
| Kinesiotaping | Other | Other: KinesiotapingApplication of anti-edema kinesiotaping |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in isolated acute ankle sprains in emergency department.
Key exclusion criteria (8 listed)
- Under 18 years
- Pregnancy
- Fracture
- 48 hours after injury
- Chronic ankle instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KinesiotapingApplication of anti-edema type kinesiotaping to injured ankle. | Other | Kinesiotaping |
Primary outcome
Karlsson score enhancement
Time frame: 0-3-7 and 28 days after injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yahya A ACAR, MD study director
Etimesgut Military Hospital Ankara/Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping in people with Sprain of Ankle, run by Etimesgut Military Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Karlsson score enhancement (time frame: 0-3-7 and 28 days after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.