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Ankle SprainsNCT03634280

Efficacy of Kinesio Taping and Splinting in Ankle Sprain

A study testing Kinesio taping in people with Ankle Sprains, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Ankle Sprains
What is being tested?
Kinesio taping
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 May 2018to 25 Sep 2018
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 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Bilgi University

    Istanbul, 34440

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Efficacy of Kinesio Taping and Splinting in Acute Treatment of Ankle Ligament Injuries

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).

Read the 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.

Conditions
Ankle Sprains
Being tested
Kinesio taping
Keywords
Ankle Sprains, Kinesio Tape, Splint
Medical subject headings
Ankle Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kinesio tapingOther

    Also called Splinting

    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.

Study groups in NCT03634280
Study groupRoleWhat they receive
SplintingPlacebo comparatorSplinting 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.
Receives: Other: Kinesio taping
Kinesio tapingExperimentalIn 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.
Receives: Other: Kinesio taping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 minutes

Secondary outcomes (3)
  1. Oedema

    Circumference measurement for severity of oedema(metatarsophalangeal joint,ankle circumference,5cm above the ankle,10cm above the ankle)

    Measured: 3 minutes

  2. Pain of ankle

    Visual analog scale

    Measured: 1 minute

  3. Range of motion

    Range of motion for the ankle with goniometer

    Measured: 3 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2018
  2. Study start2 May 2018
  3. Primary completion1 Aug 2018
  4. Study completion25 Sep 2018

Resources

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
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)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03634280
Sponsor's protocol ID
2018.05.1.02.045
Status last verified
Sep 2019
First submitted
13 Aug 2018
Last updated
6 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Kinesio taping in people with Ankle Sprains, run by Istanbul Bilgi University 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 3 inclusion and 4 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 6 Sep 2019. 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?

Disability (time frame: 5 minutes). 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 6 Sep 2019.

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