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Efficacy of Kinesio Taping and Splinting in Ankle Sprain

Primary Purpose

Ankle Sprains

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio taping
Sponsored by
Istanbul Bilgi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprains focused on measuring Ankle Sprains, Kinesio Tape, Splint

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age older than 18 years
  • Presence of ankle sprain without osseous pathology
  • Injury having occurred within the last 72 h

Exclusion Criteria:

  • Presence of fracture, open wound
  • Motor or sensory deficits associated with injury
  • Systemic oedema in the lower extremities related to the heart or kidney, venous diseases
  • Past surgery

Sites / Locations

  • Istanbul Bilgi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Splinting

Kinesio taping

Arm Description

Splinting was applied to the patients' ankle in the second group(n=120). Splint were kept on the patients for 5 days for 23 hours a day. In patients in the splint group, 16-18 layers of cotton gauze (15-cm cast gauze) were applied from the tip of the toes to the beginning of the fibula. Following the gauze application, short leg splint application was performed in a neutral ankle position.

In this study, Kinesio Tape Tex Gold® kinesio tape over lateral ankle (5cm*5m) is used. 120 participants were taped for a lateral ankle sprain. 50-mm wide and 0.5-mm thick KT was applied to the tendinomuscular meridian around the ankle with three I-shaped tapes. Initially, one I-shaped tape was applied along the course of the tibialis anterior muscle, and another I-shaped tape was then applied to the peroneus longus and brevis muscles. The third I-shaped tape was applied from the abductor digiti minimi muscle and wrapped around the ankle in a figure-of-eight shape to the abductor hallucis muscle, surrounding the ankle over the medial and lateral malleoli. The tape was applied to the skin by applying zero tension, and skin problems were avoided.

Outcomes

Primary Outcome Measures

Disability
Foot Function Index: The FFI is designed to measure both current state, defined as the past week, and change in status. It consists of 23 items grouped into three sub-scales. Because the FFI was developed for use with a predominately elderly outpatient population, it was designed to be both short and simple. The number of items was minimized to reflect this consideration. The sub-scales were formed to provide information on three unique aspects of function-foot pain, disability and activity limitation-as they related to foot pathology. A score is derived for each item by dividing the attached horizontal line into 10 equal segments and assigning a number ranging from 0 to 9 to each segment. To obtain a sub-scale score, the item scores for a sub-scale are totaled and then divided by the maximum total possible for all of the sub-scale items which the patient indicated were applicable.

Secondary Outcome Measures

Oedema
Circumference measurement for severity of oedema(metatarsophalangeal joint,ankle circumference,5cm above the ankle,10cm above the ankle)
Pain of ankle
Visual analog scale
Range of motion
Range of motion for the ankle with goniometer

Full Information

First Posted
August 13, 2018
Last Updated
September 4, 2019
Sponsor
Istanbul Bilgi University
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1. Study Identification

Unique Protocol Identification Number
NCT03634280
Brief Title
Efficacy of Kinesio Taping and Splinting in Ankle Sprain
Official Title
Comparison of the Efficacy of Kinesio Taping and Splinting in Acute Treatment of Ankle Ligament Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
September 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Bilgi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Question:Does kinesiotaping(KT) reduce oedema, pain, disability and increase range of joint motion on patients with acute ankle ligament injuries? Design:Two-group, randomised, controlled trial with blinded assessors. Participants:This study included 240 patients with acute ankle sprain.The patients were randomised using randomisation software and divided into two groups each comprising 120 patients. Intervention:Tape and splint were kept on the patients for 5 days. Outcome measures:The following parameters were evaluated before and after treatment: circumference measurement for severity of oedema(metatarsophalangeal joint,ankle circumference,5cm above the ankle,10cm above the ankle),visual analog scale(VAS) pain score,range of motion(ROM) for the ankle with goniometer and disability level via the Foot Function Index (FFI).
Detailed Description
This study included 240 patients with acute ankle sprain admitted to the Emergency Department of Bağcılar Training and Research Hospital. Before initiating the study, approval of the Bağcılar Training and Research Hospital Clinical Investigations Ethics Committee was obtained with a decree number of 2018.05.1.02.045 dated 11/05/2018. The patients were randomised using randomisation software and divided into two groups each comprising 120 patients. Kinesio taping (KT) was applied to the patients in the first group, and splinting was applied to the patients in the second group. Tape and splint were kept on the patients for 5 days. Study inclusion criteria were age older than 18 years, presence of ankle sprain without osseous pathology and injury having occurred within the last 72 h. Exclusion criteria were the presence of fracture, open wound, motor or sensory deficits associated with injury, systemic oedema in the lower extremities related to the heart or kidney, venous diseases and past surgery. The following parameters were evaluated before and after treatment: circumference measurement for severity of oedema (metatarsophalangeal joint, ankle circumference, 5 cm above the ankle, 10 cm above the ankle), VAS pain score, flexion, extension, inversion and eversion range of motion for the ankle with goniometer and disability level via the Foot Function Index (FFI). The FFI is a widely used, self-administered instrument developed to measure the effects of foot pathologies on pain, disability and activity restriction. Turkish validity and reliability studies of FFI have been previously conducted. The FFI consists of 23 items assessed for three subscales: pain, disability and activity restriction. The pain subscale, which includes nine items, measures the level of foot pain in various situations, whereas the disability subscale, which includes nine items, identifies the degree of difficulty in performing various functional activities due to foot problems. The activity restriction subscale, which includes five items, is used to assess activity restriction due to foot problems. Patients score all items using a VAS, taking into account their foot condition 1 week earlier. To calculate subscale and total scale scores, the score of each item is summed, divided by the sum of the maximum scores of the items and multiplied by 100. Higher scores indicate more pain, disability and activity restriction. If the patient is unable to perform activities, such as walking barefoot or using an orthosis, this item may be marked as not valid and removed from the total if possible. Intervention KT application: 50-mm wide and 0.5-mm thick KT was applied to the tendinomuscular meridian around the ankle with three I-shaped tapes. Initially, one I-shaped tape was applied along the course of the tibialis anterior muscle, and another I-shaped tape was then applied to the peroneus longus and brevis muscles. The third I-shaped tape was applied from the abductor digiti minimi muscle and wrapped around the ankle in a figure-of-eight shape to the abductor hallucis muscle, surrounding the ankle over the medial and lateral malleoli. The tape was applied to the skin by applying zero tension, and skin problems were avoided. In patients in the splint group, 16-18 layers of cotton gauze (15-cm cast gauze) were applied from the tip of the toes to the beginning of the fibula. Following the gauze application, short leg splint application was performed in a neutral ankle position.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains
Keywords
Ankle Sprains, Kinesio Tape, Splint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients were randomised using randomisation software and divided into two groups each comprising 120 patients. Tape and splint were kept on the patients for 5 days.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Splinting
Arm Type
Placebo Comparator
Arm Description
Splinting was applied to the patients' ankle in the second group(n=120). Splint were kept on the patients for 5 days for 23 hours a day. In patients in the splint group, 16-18 layers of cotton gauze (15-cm cast gauze) were applied from the tip of the toes to the beginning of the fibula. Following the gauze application, short leg splint application was performed in a neutral ankle position.
Arm Title
Kinesio taping
Arm Type
Experimental
Arm Description
In this study, Kinesio Tape Tex Gold® kinesio tape over lateral ankle (5cm*5m) is used. 120 participants were taped for a lateral ankle sprain. 50-mm wide and 0.5-mm thick KT was applied to the tendinomuscular meridian around the ankle with three I-shaped tapes. Initially, one I-shaped tape was applied along the course of the tibialis anterior muscle, and another I-shaped tape was then applied to the peroneus longus and brevis muscles. The third I-shaped tape was applied from the abductor digiti minimi muscle and wrapped around the ankle in a figure-of-eight shape to the abductor hallucis muscle, surrounding the ankle over the medial and lateral malleoli. The tape was applied to the skin by applying zero tension, and skin problems were avoided.
Intervention Type
Other
Intervention Name(s)
Kinesio taping
Other Intervention Name(s)
Splinting
Intervention Description
In patients in the splint group, 16-18 layers of cotton gauze (15-cm cast gauze) were applied from the tip of the toes to the beginning of the fibula. Following the gauze application, short leg splint application was performed in a neutral ankle position.
Primary Outcome Measure Information:
Title
Disability
Description
Foot Function Index: The FFI is designed to measure both current state, defined as the past week, and change in status. It consists of 23 items grouped into three sub-scales. Because the FFI was developed for use with a predominately elderly outpatient population, it was designed to be both short and simple. The number of items was minimized to reflect this consideration. The sub-scales were formed to provide information on three unique aspects of function-foot pain, disability and activity limitation-as they related to foot pathology. A score is derived for each item by dividing the attached horizontal line into 10 equal segments and assigning a number ranging from 0 to 9 to each segment. To obtain a sub-scale score, the item scores for a sub-scale are totaled and then divided by the maximum total possible for all of the sub-scale items which the patient indicated were applicable.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Oedema
Description
Circumference measurement for severity of oedema(metatarsophalangeal joint,ankle circumference,5cm above the ankle,10cm above the ankle)
Time Frame
3 minutes
Title
Pain of ankle
Description
Visual analog scale
Time Frame
1 minute
Title
Range of motion
Description
Range of motion for the ankle with goniometer
Time Frame
3 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age older than 18 years Presence of ankle sprain without osseous pathology Injury having occurred within the last 72 h Exclusion Criteria: Presence of fracture, open wound Motor or sensory deficits associated with injury Systemic oedema in the lower extremities related to the heart or kidney, venous diseases Past surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TOMRIS DUYMAZ
Organizational Affiliation
Istanbul Bilgi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Bilgi University
City
Istanbul
ZIP/Postal Code
34440
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy of Kinesio Taping and Splinting in Ankle Sprain

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