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MYOSITISPhase 1NCT02501915

Kinesio Taping Effects Applied With Different Directions and Tensions

A Phase 1 study testing Kinesio Taping in people with MYOSITIS, run by Universidade Estadual de Goiás.

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

The Kinesio Taping (KT ) method was developed more than thirty years ago in order to cause sensory effects through the epidermis and dermis, generating a variety of physiological effects in other systems. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
MYOSITIS
What is being tested?
Kinesio Taping
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Feb 2014to Jan 2015
Phase
Phase 1
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 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Individuals who have authorized the evaluation procedure and through the Term Informed Consent;
  • Individuals male and female of any race, duly enrolled in some college course of Universidade Salgado de Oliveira aged between 18-50 years old;
  • Healthy subjects without disorders of locomotion without injury history the last 6 months in the lower limbs.

Who cannot join

  • They are considered unfit for research individuals who do not meet the requirements listed above ;
  • Individuals who have higher body mass index (BMI ) to 24.99, as the concentrated presence of fat on muscles can limit the effect of bracing;
  • Individuals with musculoskeletal disorders and referring pain. Since there report that the pain and dysfunction of movement restricted range of motion and function muscular18 ;
  • Individuals who possess too much on the thigh in which prevent proper attachment of bracing and the EMG electrode , or who refuse to perform the trichotomy .
  • they show taping allergy ( an allergy test by putting a small bandage on the skin will be held and observed for 24 hours ) ;
  • Patients with any contraindication how physical activity according to the guideline of the American College of Sports Medicine (ACSM , 1995), nerve root involvement, cardiorespiratory conditions and pregnancy .

About this study

Official title: Kinesio Taping Effects Applied With Different Directions and Tensions on Electromyography, Electroencephalography, Local Temperature and Muscle Strength

The Kinesio Taping (KT ) method was developed more than thirty years ago in order to cause sensory effects through the epidermis and dermis, generating a variety of physiological effects in other systems. Clinical effects are well known levels in muscle, neurological system, injuries, inflammation, edema, among other physiological effects are thus largely in the theoretical framework. Objectives: The aim of this study is to evaluate the Electromyographic (EMG), Electroencephalographic (EEG), muscle temperature and flexibility effects with the Rectus Femoral muscle KT application. Methods: This is a pilot study with six subjects in which they were divided into two groups, A and B. Group A received the application of KT from muscle Origin to Insertion and group B Insertion to Origin, with both groups taped the non-dominant limb and the dominant limb was used as control group. The first application was conducted at 0% and the second with 75 to 100% tension. Evaluations were performed before the first application, immediately and 24 hours later. After this last evaluation, was withdrawn taping, evaluated without taping, reapplied 75 to 100 % of rated voltage and in sequence. The sixth last review was conducted 24 hours after this last application. Before every application a specific vibration was performed on the patellar tendon in order to trigger a neurophysiological imbalance rectus femoral.

Conditions
MYOSITIS
Being tested
Kinesio Taping
Keywords
Muscle
Medical subject headings
Myositis

What participants receive

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

  • Kinesio TapingDevice

    Also called Kinesio Tex Tape FP (Finger Print)

    Group A received the application of KT from muscle Origin to Insertion and group B Insertion to Origin, with both groups taped the nondominant limb and the dominant limb was used as control group. Diferent tensions will be applied with the tape to see its possible different affect in the outcomes.

Study groups in NCT02501915
Study groupRoleWhat they receive
Kinesio Taping (GROUP A)ExperimentalReceived the application of KT from muscle Origin to Insertion
Receives: Device: Kinesio Taping
Kinesio Taping (GROUP B)Experimentalreceived the application of KT from muscle Insertion to Origen
Receives: Device: Kinesio Taping

What is being measured

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

  1. Muscle Activity

    Group A (n= 15) received the application of KT from muscle (Rectus femoral) Origin to Insertion, Group B (n= 15) from insertion to origin at the non dominant limb, and the dominant limb will be used as control group. The Eletromiography/ EMG (mV) will be measure during an maximum isometric voluntary contraction.

    Measured: The outcome will be evaluated 24 hours after the intervention

Secondary outcomes (1)

  1. Neurologic Activity

    Group A (n= 15) received the application of KT from muscle (Rectus femoral) Origin to Insertion, Group B (n= 15) from insertion to origin at the non dominant limb, and the dominant limb will be used as control group. The Eletroencephalography - EEG (Hz) will be measure during an maximum isometric voluntary contraction. Will be analyzed 8 channels related with the motor activity located between the frontal and the central lobe.

    Measured: The outcome will be evaluated 24 hours after the intervention

Timeline

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

  1. First posted17 Jul 2015 (estimated)
  2. Study startFeb 2014
  3. Primary completionDec 2014
  4. Study completionJan 2015

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02501915
Sponsor's protocol ID
26582214.4.0000.5289
Status last verified
Jul 2015
First submitted
12 Feb 2014
Last updated
21 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Lemos TV, Junior JRS, Santos MGRD, Rosa MMN, Silva LGCD, Matheus JPC. Kinesio Taping effects with different directions and tensions on strength and range of movement of the knee: a randomized controlled trial. Braz J Phys Ther. 2018 Jul-Aug;22(4):283-290. doi: 10.1016/j.bjpt.2018.04.001. Epub 2018 Apr 14.

    PubMed 29728298

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Kinesio Taping in people with MYOSITIS, run by Universidade Estadual de Goiás.

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 6 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 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Muscle Activity (time frame: The outcome will be evaluated 24 hours after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02501915, which also lists 1 linked publication.

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 21 Jul 2015.

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