ANZCTR - Registration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12613001272785

Ethics application status

Approved

Date submitted

15/11/2013

Date registered

19/11/2013

Date last updated

19/11/2013

Type of registration

Retrospectively registered

Titles & IDs

Public title

Kinesiology Taping on muscle performance of quadriceps femoris.

Scientific title

Influence of Kinesiology Taping on muscle flexibility and bioelectrical activity of quadriceps femoris: a randomized, placebo controlled pilot study in healthy volleyball players.

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

muscle performance in healthy athletes

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

Normal musculoskeletal and cartilage development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The aim of this study was to assess the effect of kinesiology taping (KT) on surface electromyographic (sEMG) activity and muscle flexibility of rectus femoris (RF), vastus lateralis (VL) and vastus medialis (VM) muscles in healthy volleyball players.

Active KT intervention:
In subjects from KT group, the one-time Kinesio Tape (Nitto Denko K-Active Tape 5m/5cm, Japan) over the RF in an Y shape was used to increase muscle strength (facilitation technique). The subjects were in a supine position, with knee joint passively flexed out of the bed at an angle of 90 degrees. The KT was applied longitudinally in descending direction, from RF origin (anterior inferior iliac spine) to its insertion (tibial tuberosity). The basis of KT was applied from 2 – 3 cm below RF origin without tension. The middle part of KT between origin and patella basis was applied without tension but during RF muscle passively stretching at flexed knee joint position. Finally two tails were circled around the patella and placed on the skin without tension at an angle of 90 degrees flexed knee joint position. In KT group intervention involved left RF (n=7) and right RF (n=5) and time of application was continued for 24 hours.

Passive PT intervention:
In subjects form PT group, the one-time adhesive non-elastic tape (Polovis Plus 5m/5cm, Poland) with no therapeutic influence over the same muscle was used. Subjects were in supine position with neutral knee joint position flexed at an angle of 30 degrees. All parts of the PT were applied longitudinally in descending direction in analogous Y shape. In PT group intervention involved left RF (n=5) and right RF (n=5) and time of application was continued for 24 hours. In both groups immediately after 24 hours, KT or PT applications were removed and athletes underwent a final assessment without tapes which was identical to the initial. All procedures were accomplished as one-session intervention in the same conditions (day time, ambient temperature, research room). All subjects were informed not to remove and unstuck the tapes until final measurements will be taken.

Intervention code [1]

Rehabilitation

Intervention code [2]

Prevention

Intervention code [3]

Treatment: Devices

Comparator / control treatment

subjects in control group received a single placebo taping intervention (PT group intervention)

Control group

Placebo

Outcomes

Primary outcome [1]

was to registry the resting sEMG activity of vastus lateralis (VL) and vastus medialis (VM) muscles; it was hypothesized that KT application would increase muscle activity in sEMG between initial and final assessment in any of two groups

Timepoint [1]

baseline and immediately after removal (at 24 hours) of KT or PT intervention

Primary outcome [2]

was to registry the resting and functional sEMG activity of rectus femoris (RF) muscle; it was hypothesized that KT application would increase muscle activity in sEMG between initial and final assessment in any of two groups

Timepoint [2]

baseline and immediately after removal (at 24 hours) of KT or PT intervention

Secondary outcome [1]

was to analyse the changes in rectus femoris (RF) muscle flexibility showed in Duncan – Ely test (DET); it was hypothesized that KT application would improve muscle flexibility in DET between initial and final assessment in any of two groups

Timepoint [1]

baseline and immediately after removal (at 24 hours) of KT or PT intervention

Eligibility

Key inclusion criteria

1. confirmed volleyball participation in Academic Sport Association;
2. lack of chronic nervous or cardiorespiratory diseases;
3. lack of acute and chronic musculoskeletal disorders;
4. lack of knowledge about rules of KT application;
5. good compliance and willingness to sign the written consent form

Minimum age

18 Years

Maximum age

25 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. lack confirmed volleyball participation in Academic Sport Association;
2. chronic diseases at present;
3. musculoskeletal disorders at present;
4. lower limb injuries at present;
5. pharmacological treatment at present;
6. recent surgery interventions;
7. confirmed knowledge about rules of KT application;
8. lack of informed consent of the patients

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Simple randomisation using a computer-generated
random numbers which were hidden in sequentially numbered envelopes and than selected by subjects. Random allotment contained KT group (W) or placebo group (X) as well as the choice of the left (Y) or right (Z) rectus femoris (RF) muscle for intervention in the same way.
The person responsible for participant allotment was not aware of the designations and therefore, did not know into which group the study participant would be included and which limb would be studied.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by
appropriate website (http://www.random.org/)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

STATISTICA 10 software by StatSoft Company was used for statistical data analysis. Arithmetic means, standard deviations and ranges of variation were calculated for measurable variables. A non – parametric Wilcoxon sequence pair test for dependent variables was used for comparison of results before and after the intervention. Statistical significance was set at p<0.05. A non – parametric U Mann – Whitney test for independent variables (p=0.05) or chi2 test (p=0.05) was used for comparison between groups.

For this pilot analyses included 22 subjects the team had to use non-parametric tests.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

2/08/2013

Actual

2/08/2013

Date of last participant enrolment

Anticipated

1/10/2013

Actual

1/10/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Opole

Funding & Sponsors

Funding source category [1]

University

Name [1]

Public Higher Medical Professional School

Address [1]

Katowicka Street 68, 45-060 Opole

Country [1]

Poland

Primary sponsor type

University

Name

Public Higher Medical Professional School

Address

Katowicka Street 68, 45-060 Opole

Country

Poland

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of Public Higher Medical Professional School

Ethics committee address [1]

Katowicka Street 68, 45-060 Opole

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

01/07/2013

Approval date [1]

01/08/2013

Ethics approval number [1]

Summary

Brief summary

Kinesiology taping (KT) is a popular method to support professional athletes during sport activities as well as a part of traumatic injury prevention and physiotherapeutic procedures after wide range of musculoskeletal injuries General clinical applications of KT include wide range of musculoskeletal injuries as low back pain, shoulder impingement syndrome, rotator cuff tendonitis chronic Achilles tendon pain or post – stroke muscles spasticity. However, some recent researches suggest an unclear and insufficient influence of KT in some cases. It is still needed to assess the short – term and long – term effectiveness of KT application on the muscles performance in supporting, prevention and rehabilitation procedures.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Tomasz Halski

Address

Department of Physiotherapy, Public Higher Professional School, Katowicka Street 68, 45-060 Opole

Country

Poland

Phone

+48 774 423 524

Fax

+48 774 423 525

[email protected]

Contact person for public queries

Name

Dr Robert Dymarek

Address

Department of Nervous System Diseases, University of Medicine in Wroclaw, Bartla Street 5, 51-618 Wroclaw

Country

Poland

Phone

+48 723 895 770

Fax

[email protected]

Contact person for scientific queries

Name

Dr Robert Dymarek

Address

Department of Nervous System Diseases, University of Medicine in Wroclaw, Bartla Street 5, 51-618 Wroclaw

Country

Poland

Phone

+48 723 895 770

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Kinesiology taping does not modify electromyographic activity or muscle flexibility of quadriceps femoris muscle: A randomized, placebo-controlled pilot study in healthy volleyball players.	2015	https://dx.doi.org/10.12659/MSM.894150

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically