Glenohumeral Internal Rotation DeficitNCT04687683
Comparison of Immediate Effects of Different Shoulder Stretching Techniques in Overhead Athletes
A study testing Post Isometric Relaxation Group, Isolytic Stretching Group and Static Stretching Group Group in people with Glenohumeral Internal Rotation Deficit, run by Dokuz Eylul University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 13 to 40 years
- Conditions the study is for
- Glenohumeral Internal Rotation Deficit
- What is being tested?
- Post Isometric Relaxation Group, Isolytic Stretching Group and Static Stretching Group Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Dec 2024
- 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 13 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
Read the 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.
- Conditions
- Glenohumeral Internal Rotation Deficit
- Being tested
- Post Isometric Relaxation Group, Isolytic Stretching Group, Static Stretching Group Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post Isometric Relaxation GroupOther
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.
Isolytic Stretching GroupOther
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.
Static Stretching Group GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Post Isometric Relaxation Group | Experimental | The participants in this group will receive post isometric relaxation stretching in modified cross body position. Receives: Other: Post Isometric Relaxation Group |
| Isolytic Stretching Group | Experimental | The participants in this group will receive isolytic stretching in modified cross body position. Receives: Other: Isolytic Stretching Group |
| Static Stretching Group Group | Experimental | The participants in this group will receive static stretching in modified cross body position. Receives: Other: Static Stretching Group Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder internal rotation range of motion
Change of shoulder internal rotation range of motion (with bubble inclinometer)
Measured: baseline measurements, 3 minutes and 30 minutes
Secondary outcomes (5)
Subacromial space
Change of subacromial space ( with Ultrasound)
Measured: baseline measurements, 3 minutes and 30 minutes
Posterior capsule thickness
Change of posterior capsule thickness ( with Ultrasound)
Measured: baseline measurements, 3 minutes and 30 minutes
Functional Throwing Performance Index
Participants will throw a ball to shot a frame on a wall. Number of correct shots will be recorded
Measured: baseline measurements, 3 minutes and 30 minutes
Shoulder Total rotation range of motion
Change of shoulder internal rotation + external rotation range of motion (with bubble inclinometer)
Measured: baseline measurements, 3 minutes and 30 minutes
Posterior shoulder tightness
Change of posterior shoulder tightness (with bubble inclinometer)
Measured: baseline measurements, 3 minutes and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Feb 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glenohumeral Internal Rotation DeficitStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Şahiner Pıçak, Dokuz Eylul University
- Investigators
- Sevgi Sevi Yeşilyaprak, Phd, Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687683
- Sponsor's protocol ID
- 5002-GOA
- Status last verified
- Jan 2023
- First submitted
- 15 Dec 2020
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immediate Effects of Different Posterior Shoulder Stretching Techniques in Overhead Athletes With Glenohumeral Internal Rotation Deficits
- ClinicalTrials.gov ID
- NCT04687683
- Acronym / sponsor ID
- 5002-GOA
- Conditions
- Glenohumeral Internal Rotation Deficit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 29 Dec 2020 (actual)
- 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.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post Isometric Relaxation Group | Experimental | Other: Post Isometric Relaxation GroupThe participants in this group will receive post isometric relaxation stretching in modified cross body position. |
| Isolytic Stretching Group | Experimental | Other: Isolytic Stretching GroupThe participants in this group will receive isolytic stretching in modified cross body position. |
| Static Stretching Group Group | Experimental | Other: Static Stretching Group GroupThe participants in this group will receive static stretching in modified cross body position. |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Post Isometric Relaxation GroupAthletes 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. | Other | Post Isometric Relaxation Group |
| Isolytic Stretching GroupAthletes 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. | Other | Isolytic Stretching Group |
| Static Stretching Group GroupAthletes 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. | Other | Static Stretching Group Group |
Primary outcome
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)
5 secondary outcomes
Subacromial space
Time frame: baseline measurements, 3 minutes and 30 minutes
Posterior capsule thickness
Time frame: baseline measurements, 3 minutes and 30 minutes
Functional Throwing Performance Index
Time frame: baseline measurements, 3 minutes and 30 minutes
Shoulder Total rotation range of motion
Time frame: baseline measurements, 3 minutes and 30 minutes
Posterior shoulder tightness
Time frame: baseline measurements, 3 minutes and 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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.
Sevgi Sevi Yeşilyaprak, Phd study director
Dokuz Eylul University
Questions about this trial
What is this clinical trial studying?
A study testing Post Isometric Relaxation Group, Isolytic Stretching Group and Static Stretching Group Group in people with Glenohumeral Internal Rotation Deficit, run by Dokuz Eylul University.
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 7 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 10 Jan 2023. 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.
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 Gonca Sahiner Pıçak, MSc (+905058081268, gncshnr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder internal rotation range of motion (time frame: baseline measurements, 3 minutes and 30 minutes). 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 10 Jan 2023.