Shoulder InjuryNCT01764620
Effects of Muscle Fatigue and a Taping Technique on Shoulder Motion of Athletes
A study testing Elastic taping applied with tension, Elastic taping applied without tension and Fatigue protocol in people with Shoulder Injury and Muscle Fatigue, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Injury, Muscle Fatigue
- What is being tested?
- Elastic taping applied with tension, Elastic taping applied without tension and Fatigue protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- May 2012to Jul 2014
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overhead athletes regularly training;
- No report of shoulder pain in the last 6 months.
Who cannot join
- Previous shoulder or neck surgery;
- Previous shoulder dislocation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de São Carlos
São Carlos, São Paulo, 13.565-905
About this study
Official title: 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.
Read the 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.
- Conditions
- Shoulder Injury, Muscle Fatigue
- Being tested
- Elastic taping applied with tension, Elastic taping applied without tension, Fatigue protocol
- Keywords
- shoulder, muscle fatigue, kinematics, athletes
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic taping applied with tensionOther
Elastic taping applied without tensionOther
Fatigue protocolOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | In this session, the athletes will be evaluated before and after the fatigue protocol, without any taping application. Receives: Other: Fatigue protocol |
| Kinesio taping | Experimental | 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. Receives: Other: Elastic taping applied with tension; Other: Fatigue protocol |
| Sham | Sham comparator | 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. Receives: Other: Elastic taping applied without tension; Other: Fatigue protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in scapular internal/external rotations, upward/downward rotations and anterior/posterior tilt movements
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).
Measured: An average of 3 minutes before and an average of 3 minutes after the fatigue protocol, in each of the 3 evaluation sessions.
Secondary outcomes (1)
Changes in the median frequency of electromyographic signal from upper and lower trapezius and serratus anterior muscles.
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).
Measured: An average of 3 minutes before and an average of 3 minutes after the fatigue protocol, in each of the 3 evaluation sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startMay 2012
- Primary completionDec 2013 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gisele Garcia Zanca, Universidade Federal de Sao Carlos
- Investigators
- Gisele G Zanca, MSc, Principal investigator, Universidade Federal de Sao CarlosStela M Mattiello, PhD, Study director, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764620
- Sponsor's protocol ID
- 040/2011
- Status last verified
- Mar 2013
- First submitted
- 18 Dec 2012
- Last updated
- 2 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Muscle Fatigue and Scapular Taping on Shoulder Kinematics of Overhead Athletes
- ClinicalTrials.gov ID
- NCT01764620
- Acronym / sponsor ID
- 040/2011
- Conditions
- Shoulder Injury, Muscle Fatigue
- Keywords
- shoulder, muscle fatigue, kinematics, athletes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Fatigue protocolIn this session, the athletes will be evaluated before and after the fatigue protocol, without any taping application. |
| Kinesio taping | Experimental | Other: Elastic taping applied with tension, Other: Fatigue protocolA 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. |
| Sham | Sham comparator | Other: Elastic taping applied without tension, Other: Fatigue protocolA 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Overhead athletes regularly training;
- No report of shoulder pain in the last 6 months.
Key exclusion criteria (2 listed)
- Previous shoulder or neck surgery;
- Previous shoulder dislocation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elastic taping applied with tension | Other | Kinesio taping |
| Elastic taping applied without tension | Other | Sham |
| Fatigue protocol | Other | Control, Kinesio taping, Sham |
Primary outcome
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).
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisele G Zanca, MSc principal investigator
Universidade Federal de Sao Carlos
Stela M Mattiello, PhD study director
Universidade Federal de Sao Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic taping applied with tension, Elastic taping applied without tension and Fatigue protocol in people with Shoulder Injury and Muscle Fatigue, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Apr 2013. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gisele G Zanca, MSc (55 16 33519579, gisele_gz@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 2 Apr 2013.