Effects of Muscle Fatigue and a Taping Technique on Shoulder Motion of Athletes

March 30, 2013 updated by: Gisele Garcia Zanca, Universidade Federal de Sao Carlos

Effects of Muscle Fatigue and Scapular Taping on Shoulder Kinematics of Overhead Athletes

The purpose of this study is to investigate the effects of muscle fatigue in the scapular kinematics of overhead athletes with and without using a kinesio taping technique for facilitating lower trapezius function. The hypothesis is that the taping technique could compensate for the negative effects caused by muscle fatigue in the scapular kinematics of healthy overhead athletes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Muscle fatigue is a potential cause of shoulder injuries in overhead athletes. Considering the important role of lower trapezius for functional scapular stability, it is suggested that a kinesio taping technique for facilitating its function could compensate for the negative effects of muscle fatigue on scapular kinematics. This is a randomized crossover study and all included athletes will be evaluated in three sessions, with a period of seven days between them: Control (fatigue protocol, without taping), Kinesio Taping (fatigue protocol with elastic taping applied with tension) and Sham (fatigue protocol with taping applied without tension). During each session, tridimensional kinematics of scapula and humerus and electromyography of serratus anterior and trapezius (upper and lower portions) muscles of dominant shoulder will be evaluated, during scaption and throwing movements, immediately before and immediately after the fatigue protocol.The changes in scapular movements (before versus after the fatigue protocol) will be compared among the sessions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • São Paulo
      • São Carlos, São Paulo, Brazil, 13.565-905
        • Recruiting
        • Universidade Federal de São Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Overhead athletes regularly training;
  • No report of shoulder pain in the last 6 months.

Exclusion criteria:

  • Previous shoulder or neck surgery;
  • Previous shoulder dislocation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Control
In this session, the athletes will be evaluated before and after the fatigue protocol, without any taping application.
Other: Fatigue protocol
Experimental: Kinesio taping
A kinesio taping technique for facilitating lower trapezius muscle function will be applied just before fatigue protocol and removed after in the end of the evaluation session.
Other: Fatigue protocol
Other: Elastic taping applied with tension
Sham Comparator: Sham
A similar technique, using the same tape, will be applied but without any tension (tension is considered to be the therapeutic effect). The tape will be applied just before the fatigue protocol and removed in the end of the session.
Other: Fatigue protocol
Other: Elastic taping applied without tension

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in scapular internal/external rotations, upward/downward rotations and anterior/posterior tilt movements
Time Frame: An average of 3 minutes before and an average of 3 minutes after the fatigue protocol, in each of the 3 evaluation sessions.
Scapular 3D kinematics will be measured during arm elevation and throwing movements, in two moments (an average of 3 minutes before and an average of 3 minutes after the fatigue protocol) in each one of the 3 sessions. The evaluation session will have and interval of 7 days between them, and in each one the athletes will perform the fatigue protocol using either a kinesio taping application, or a sham application or without using any taping, in random order. The changes in each session (before and after fatigue) will be compared among the sessions (without taping, with kinesio taping application and sham application).
An average of 3 minutes before and an average of 3 minutes after the fatigue protocol, in each of the 3 evaluation sessions.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in the median frequency of electromyographic signal from upper and lower trapezius and serratus anterior muscles.
Time Frame: An average of 3 minutes before and an average of 3 minutes after the fatigue protocol, in each of the 3 evaluation sessions.
Electromyographic median frequency will be measured from upper and lower trapezius and serratus anterior muscles in order to determine muscle fatigue development and if the changes depending on the intervention used. These assessments will be performed in two moments (an average of 3 minutes before and an average of 3 minutes after the fatigue protocol) in each one of the 3 sessions(with an interval of 7 days between them). In each session the athletes will perform the fatigue protocol using either a kinesio taping application, or a sham application or without using any taping, in random order.The changes in each session (before and after fatigue) will be compared among the sessions (without taping, with kinesio taping application and sham).
An average of 3 minutes before and an average of 3 minutes after the fatigue protocol, in each of the 3 evaluation sessions.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Sao Carlos

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gisele G Zanca, MSc, Universidade Federal de São Carlos
  • Study Director: Stela M Mattiello, PhD, Universidade Federal de São Carlos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 040/2011

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