Comparison of Immediate Effects of Different Shoulder Stretching Techniques in Overhead Athletes

January 9, 2023 updated by: Gonca Şahiner Pıçak, Dokuz Eylul University

Comparison of Immediate Effects of Different Posterior Shoulder Stretching Techniques in Overhead Athletes With Glenohumeral Internal Rotation Deficits

81 overhead athletes with Glenohumeral Internal Rotation Deficit (GIRD) will be included in this study. Participants will be randomly divided into 3 different groups of 26 people. In each group will be applied posterior shoulder stretching exercises (PSSE) performed with different Muscle Energy Techniques (MET).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

Post Isometric Relaxation Group (PIRG) participants will perform a PSSE with post isometric relaxation (PIR) technique, Isolytic Stretching Group (ISG) participants will perform a PSSE with isolytic stretching technique and Static Stretching Group Group (SSG) participants will perform a PSSE with static stretching technique. All exercises will be performed in the modified cross-body position. Subacromial space and posterior capsule thickness will be measured using a 7-12 MHz linear transducer with USG (LOGIQ e Ultrasound, GE Healthcare, USA). Athletes' GIRD results and rotational ROM measurements will be measured and recorded using a bubble inclinometer (Fabrication End Inc, New York, USA). The upper extremity functional performance of the athletes will be evaluated with the Functional Throwing Performance Index (FTPI). Evaluations will be repeated tree times before, after the stretching exercise and 30 minutes later and the effects of different muscle energy techniques (MET) will be compared. Investigators hypothesized PSSE made with different MET techniques have different effects on Acromio-Humeral Distance, posterior capsule thickness, rotational ROM measurements and performance on overhead athletes with GIRD and the effects of MET would be superior to static stretching.

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.
81

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.
  • Name: Gonca Şahiner Pıçak, MSc
  • Phone Number: +905058081268
  • Email: gncshnr@gmail.com

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

13 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being overhead athlete
  • Glenohumeral internal rotation range of motion of the affected shoulder should be less than other shoulder and bilateral shoulder internal rotation range of motion difference should be ≥15 º

Exclusion Criteria:

  • Shoulder pain required medical attention for the last year.
  • Current shoulder pain
  • Cervical pain during upper extremity movement
  • History of fracture to the shoulder girdle
  • Systemic musculoskeletal disease
  • History of shoulder surgery,
  • Glenohumeral instability (positive apprehension, relocation, or positive sulcus test) or positive findings for a full thickness rotator cuff tear (positive lag sign, positive drop arm test, or marked weakness with shoulder external rotation)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel 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.
Experimental: Post Isometric Relaxation Group
The participants in this group will receive post isometric relaxation stretching in modified cross body position.
Other: Post Isometric Relaxation Group
Athletes will be positioned in a modified cross-body position. They will be asked to actively bring their underlying arm in the direction of horizontal adduction up to the physiological barrier barrier. The participants will be asked to perform an isometric contraction for 5 seconds in the horizontal abduction direction with 20% of the maximum muscle strength. After the relaxation, the arm will be moved towards horizontal adduction and 15 seconds active-assistive stretching will be applied. Participants will be given a 5-second rest period between contractions. This stretching exercise will be applied in 5 repetitions for one session.
Experimental: Isolytic Stretching Group
The participants in this group will receive isolytic stretching in modified cross body position.
Other: Isolytic Stretching Group
Athletes will be positioned in a modified cross-body position. They will be asked to actively bring their underlying arm in the direction of horizontal adduction up to the physiological barrier barrier. The participants will be asked to perform a contraction in the horizontal abduction direction with 20% of the maximum muscle strength. When the muscle contraction occurs, the arm will be moved quickly in 2-4 seconds towards horizontal adduction and 15 seconds active-assistive stretching will be applied. Participants will be given a 5-second rest period between stretches. This stretching exercise will be applied in 5 repetitions for one session.
Experimental: Static Stretching Group Group
The participants in this group will receive static stretching in modified cross body position.
Other: Static Stretching Group Group
Athletes will be positioned in a modified cross-body position. They will be asked to actively bring their underlying arm in the direction of horizontal adduction up to the physiological barrier. Then, the arm will be moved towards horizontal adduction and 15 seconds active-assistive stretching will be applied. Participants will be given a 5-second rest period between stretching exercises. This stretching exercise will be applied in 5 repetitions for one session.

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
Shoulder internal rotation range of motion
Time Frame: baseline measurements, 3 minutes and 30 minutes
Change of shoulder internal rotation range of motion (with bubble inclinometer)
baseline measurements, 3 minutes and 30 minutes

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
Subacromial space
Time Frame: baseline measurements, 3 minutes and 30 minutes
Change of subacromial space ( with Ultrasound)
baseline measurements, 3 minutes and 30 minutes
Posterior capsule thickness
Time Frame: baseline measurements, 3 minutes and 30 minutes
Change of posterior capsule thickness ( with Ultrasound)
baseline measurements, 3 minutes and 30 minutes
Functional Throwing Performance Index
Time Frame: baseline measurements, 3 minutes and 30 minutes
Participants will throw a ball to shot a frame on a wall. Number of correct shots will be recorded
baseline measurements, 3 minutes and 30 minutes
Shoulder Total rotation range of motion
Time Frame: baseline measurements, 3 minutes and 30 minutes
Change of shoulder internal rotation + external rotation range of motion (with bubble inclinometer)
baseline measurements, 3 minutes and 30 minutes
Posterior shoulder tightness
Time Frame: baseline measurements, 3 minutes and 30 minutes
Change of posterior shoulder tightness (with bubble inclinometer)
baseline measurements, 3 minutes and 30 minutes

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.
Dokuz Eylul University

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 (Anticipated)

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.
February 1, 2023

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.
February 1, 2024

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.
December 1, 2024

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 15, 2020

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.
December 27, 2020

First Posted (Actual)

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.
December 29, 2020

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.
January 10, 2023

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.
January 9, 2023

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.
January 1, 2023

More Information

Terms related to this study

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.
  • 5002-GOA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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